Drug shortages in America

Amid shortages of Pfizer’s antibiotic Bicillin L-A, Mark Cuban’s company will import 1.2 million units of Lentocilin from Portugal. By Lecia Bushak It’s Mark Cuban to the rescue for this drug shortage. Mark Cuban’s Cost Plus Drugs Company will temporarily import penicillin into the U.S. from a Portugal-based pharma company to help ease shortages of Pfizer’s Bicillin L-A, the Food and Drug Administration announced this week. Cost Plus Drugs will work with Laboratórios Atral S.A. to import 1.2 million units of Lentocilin powder and diluent for suspension for injection. The FDA originally listed Bicillin L-A as being in shortage last year. As of June, Pfizer said it has an available supply of 2.4 million units, but full availability of the drug may not happen until later in the year. Atral noted in documents that Lentocilin is not approved by the FDA and added that healthcare providers should be aware that Lentocilin S Suspension for injection must be administered “exclusively by deep intramuscular injection.” Bicillin L-A, a penicillin antibiotic that treats infections like syphilis and strep throat, is among the more than 300 drugs currently in shortage in the U.S. The factors behind the record-high shortages are complex and allowing pharma companies overseas to import drugs is only a temporary solution. This isn’t the first time in 2024 the FDA has made such a move. Earlier this year, the agency allowed French pharma Laboratoires Delbert to import another syphilis drug, extencilline. At the time, the agency noted importing extencilline would help mitigate rising syphilis cases. In March, Cost Plus Drugs also struck a partnership with Community Health Systems (CHS) to begin selling generic medications to the health system to help ease drug shortages. As part of the initial rollout of the partnership, Cost Plus Drugs is providing CHS with epinephrine and norepinephrine. This is the latest – albeit relatively unexpected – development for Mark Cuban’s healthcare enterprise. Cost Plus Drugs launched in 2022 with the goal of disrupting the pharma industry by avoiding middlemen known as pharmacy benefit managers (PBMs) and providing affordable drug prices. The organization also aims to provide transparency into drug prices so that Americans “know they are getting a fair price,” it says on its website. Other drugs affected by the ongoing shortages include cancer drugs, GLP-1s and attention-deficit/hyperactivity disorder (ADHD) drugs like Adderall. A recent report found that in addition to more drugs being listed in shortage than ever before, the shortages are also lasting longer. The average drug shortage duration is now over three years, compared to just two years in 2020, according to US Pharmacopeia.

Check out six of the latest drugs to face scarcity issues, what is causing these issues and when they can return to supply. By Molly Huth Though the chemotherapy drug cisplatin is now back in available supply, six other drugs have gone into shortage, according to multiple drug databases. Check out six of the latest drugs to face scarcity issues, what is causing these issues and when they can return to supply. 1. Dexmedetomidine hydrochloride 100 micrograms per milliliter vial for injection is used to sedate intubated adult patients in ICU and non-intubated adults in surgery. Though Accord Healthcare, Eugia Pharma and Hikma Pharmaceuticals did not specify a reason for a shortage, or a specific date for resupply, Sagent Pharmaceuticals said its supply should normalize at some point this month. 2. Betaxolol Hydrochloride Ophthalmic Suspension is a beta blocker which is used to treat glaucoma by decreasing the pressure in the eyes. This drug is in shortage due to a business decision by Novartis to halt production of the product. 3. Insulin Aspart Protamine and Insulin Aspart Mix is a mixture between fast acting-insulin and immediate-acting insulin for diabetes patients. Novo Nordisk did not specify a reason behind the shortage but two other versions of the drug are currently available. 4. Nystatin Oral Suspension is used to treat fungal and yeast infections in the mouth, often known as thrush. Leading Pharma and Pharmaceutical Associates did not specify a reason behind the shortage. Meanwhile, Wockhardt discontinued its version and said it is distributing the remaining inventory. 5. Cathflo Activase (alteplase injection) is used to prevent blood clots throughout the body and in turn prevent heart attacks, strokes, pulmonary embolisms and improve flow of medication via catheter. The drug is currently in shortage due to a voluntary recall of two batches by Genentech due to defective stoppers. 6. Dorzolamide ophthalmic solution is a form of eye drops used to decrease pressure in the eyes caused by open-eye glaucoma and hypertension in the eyes. Bausch Health, Leading Pharma and Sanoz did not specify a reason for the shortage.

While cisplatin is now available, other cancer drugs remain in limited supply as drug shortages continue nationwide. By Lecia Bushak A chemotherapy drug that had been in shortage for months is now available again, according to the Food and Drug Administration. Amid record-high drug shortages impacting over 300 medications, cisplatin – a chemotherapy injection that’s used to battle bladder, ovarian or testicular cancer – is now back in supply. FDA Commissioner Dr. Robert Califf posted on X last week noting that the national shortage of the critical cancer drug was over. “Since the shortage was announced last year, we’ve taken strategic steps within our statutory authority to tackle cancer drug supply issues,” Califf wrote. “The FDA will continue to work with drug manufacturers, supply chain companies, health systems and clinicians, including pharmacists, to help restore access to essential cancer treatments and other medicines that are currently in short supply.” The shortages impacting cisplatin and other cancer drugs have had a severe impact on healthcare providers and patients, as physicians have reported having to ration medication or delay treatments. A recent survey out of the nonprofit National Comprehensive Cancer Network (NCCN), found that only 7% of surveyed cancer centers reported a shortage of cisplatin as of June – compared to 70% in June 2023. However, the survey also highlighted emerging concerns, as 89% of the cancer centers surveyed reported shortages of important anti-cancer agents as well as supportive care medications. Nearly 60% of cancer centers reported a shortage of vinblastine, 46% reported etoposide was in short supply and 43% were facing shortages of topotecan. Other cancer drugs facing shortages include dacarbazine, 5-fluorouracil and methotrexate. “Most of them are still managing shortages for more than one type of medication right now,” NCCN CEO Crystal Denlinger said in a statement. “These shortages not only put a burden on patients, caregivers and providers, but they could also delay vital clinical trials and slow the pace of progress for new cancer therapies.” Many of those drugs “form the backbones” of effective multi-agent regiments across both curative and palliative treatment settings, the NCCN added. It also appears that these persistent drug shortages are having an impact beyond immediate patient care. The survey found that clinicals trials were feeling a negative impact, with 43% of centers reporting that shortages were affecting budgets, enrollment and administrative burden. Alyssa Schatz, senior director of policy and advocacy at NCCN, argued in a statement that the federal government will need to establish economic incentives – like tax breaks of manufacturing grants – for generic drugmakers in order to spur increased supply. The survey results echoed that sentiment, with 75% of cancer centers noting they’d like to see the federal government create economic incentives to encourage generic drugmakers to make more affordable cancer drugs.

U.S. has reached peak medicine scarcity 

The medicines supply crunch has reached a high, with access uncertainty surrounding many life-saving drugs.  By Marc Iskowitz Much like strained supply led to pandemic-era hoarding of household items, overbuying of medicines due to access uncertainty is exacerbating some drug shortages. Indeed, the emergence of a kind of pharmaceutical panic-purchase is one of several phenomena triggered by vulnerabilities in the medicine supply chain, according to a recent report. A “multifaceted and interrelated” mix of factors has resulted in a fragile market for medicines, says United States Pharmacopeia (USP), the longstanding compendium of drug information which is also involved in mitigating shortages. These factors range from price, geography, manufacturing and quality issues. Taken together, USP explains, they’ve decreased the resilience of the supply chain and have led to an increase in the number and duration of drug shortages.

What drugs are in shortage?

At the end of 2023, the Food and Drug Administration was tracking 125 active drug shortages, over a quarter of which were new. This number has increased steadily over the past decade. Two other groups tracking shortages, the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service, tallied 323 total active shortages during the first quarter of 2024. That’s the highest number since officials began tracking data more than two decades ago, eclipsing the previous all-time record of 320 shortages in 2014, per ASHP. Through March, there were nearly 50 new shortages. The average duration of all shortages hit nearly three years, up from a nearly two-year span in 2020. These drugs are also staying in shortage for longer time periods, with almost a quarter spending more than five years in shortage, USP noted. Underscoring the persistence and slow pace associated with resolving drug shortages, only a small percent of those new drug shortages – four products – was reported and resolved within 2023. According to several groups, older injectable hospital drugs are particularly susceptible. USP’s Medicine Supply Map identified a severe risk of shortage for 91% of generic sterile injectables in 2023. That includes 58% of injectable drugs that newly entered shortage last year, although USP observed that no one therapeutic class of drugs was disproportionately affected. Its list ranges from standard of care chemotherapy, to antibiotic clindamycin to liraglutide, Novo Nordisk’s GLP-1 drug Victoza. Other basic and life-saving products on the shortage list include oxytocin, Rho(D) immune globulin, pain and sedation medications, as well as ADHD meds.

What is causing drug shortages?

Race-to-the-bottom pricing is one factor contributing to the fragility of the system in general. The majority of drugs in shortage are priced under $5 – both injectables and solid oral dose medications. Meanwhile, branded drugs, which tend to have higher prices, are less likely to go into shortage. Low prices create vulnerability in the supply chain because a lack of favorable pricing can prompt a manufacturer to decide to discontinue that product, resulting in fewer drugmakers in a given market. For instance, nearly half of discontinued products last year were low-margin oral meds, USP found. The supply chain itself has become more complex and fragmented. USP’s Medicine Supply Map shows that in 2021, the United States accounted for just 10% of active pharmaceutical ingredient (API), the key starting materials for drugs, with India accounting for 50%. This demonstrates how reliant the United States is on international sources to manufacture a finished drug product, even though it’s the largest producer of sterile injectables and second largest maker of solid orals as finished products. Then there are the quality issues. As the FDA, which paused inspections during COVID-19, gets back to factories it hasn’t visited for several years, its inspectors are finding faults. Fixes for production to get fully back on track, can take anywhere from six to 18 months. USP’s data show that facilities that account for nearly 40% of the production volume for drugs in shortage received inspection results of “voluntary action indicated” (VAI) – meaning that objectionable conditions were found, but the inspectors did not take regulatory action. Then again, sometimes safety and quality issues identified at a facility can result in an action, leading the facility to halt supply. That was what happened in the well-publicized 2023 case of cancer drug cisplatin, a sterile injectable medicine which is complex to make. The FDA identified a range of issues at the facility, which was responsible for about half of all cisplatin in the U.S. market. At the time, few other companies were producing this low-priced product, so others didn’t necessarily have the capacity to ramp up production to make up the difference. Meanwhile, the manufacturer stopped all production at the inspected facility. Press coverage fueled uncertainty about access among groups that rely on these lifesaving products for their patients and that uncertainty likely caused panic-driven overbuying. Indeed, USP found that the volume of cisplatin sold in the U.S. market was 17% greater in the one month and 15% greater six months following the report of the shortage.  Ditto for carboplatin. As of May, both drugs were still listed on the FDA’s drug shortage database. “Since there were no changes in how these drugs were utilized clinically in this time period, demand from protective purchasing for carboplatin and cisplatin likely increased and exacerbated the shortage,” USP wrote.

What can be done to fix it?

If the cisplatin case exemplifies how the vulnerabilities and the effects of a single shock can conspire to wreak havoc on an already fragile market, they also hold the key to shoring up the system to prevent future crunches. Shortages may have hit a high-water mark, but experts say strengthening the medicines supply chain can stem the tide. Among policy solutions, USP’s report suggests creating incentives that differentiate suppliers based on reliability and resilience, as well as building an early warning capability to prevent being blind-sided by crises in the supply chain. The group also recommends fostering more geographic diversity in the manufacturing base for drug products, identifying drugs at risk for shortage and establishing a list of vulnerable medicines and coordinating supply chain resilience and reliability efforts. Momentum is growing on that front. Last year Congress held four hearings on shortages, and congressional action on the issue may be imminent. ASHP joined a White House-sponsored roundtable last July, along with manufacturers, providers, and others to discuss national shortages in key cancer medications and provide steps the federal government could take to expand availability and access to medications. University of Utah’s Erin Fox, the university’s associate chief pharmacy officer who’s been providing data on drug shortages since 2001, told the Associated Press that “this is truly the most interest I’ve ever seen.”

Politicians on both sides of the aisle have called out U.S. dependence on manufacturing overseas as one of the many factors behind drug shortages. By Lecia Bushak Factors behind the record-high level of the nation’s drug shortages are myriad and complex, but more politicians are pinpointing the U.S. dependence on foreign manufacturing as a leading role in the crisis. As such, lawmakers from both sides of the political aisle have sought to find solutions to the issue as patients continue to report having to ration medication or wait for weeks to fill a prescription. Last month, Senate Finance Committee chair Ron Wyden, (D-Ore.), and ranking member Mike Crapo, (R-Idaho), crafted a draft bill that would create a new Medicare program to encourage transparent purchasing practices among healthcare providers. This came months after Democratic lawmakers led by Rep. Jamie Raskin, (D-MD), targeted Big Pharma companies like Pfizer, Sandoz and Teva Pharmaceuticals as the culprits in drug shortages, and called on them to address the problem. Yet others have pinned the blame on the Food and Drug Administration’s slowdown  of drug manufacturing inspections, as well as America’s ties to drugmakers overseas, particularly in China and India. What policymakers should do to fix this multifaceted problem remains up in the air but some have ideas for suggested actions. In a guest column published in The Mercury this week, Nick Iacovella, SVP of public affairs and communications at the nonprofit Coalition for a Prosperous America, argued that the U.S. has become “dangerously dependent” on foreign manufacturers,” adding that generic drugs account for 91% of all U.S. prescriptions. For the record, the Coalition for a Prosperous America states on its website that it advocates “strategic trade, tax and growth policies” in the interest of its “bipartisan coalition of farmers, ranchers, manufacturers and labor organizations.” Of note, Iacovella was the former deputy director of communications for Sen. Marco Rubio, (R-FL). Iacovella argued in his column that Chinese and Indian manufacturers’ global share of active pharmaceutical ingredient filings has increased in the last several decades to a point where drugmakers from these countries supply much of the generic drug supply in the U.S. He added that lawmakers in Congress will need to craft a “comprehensive approach” to drug shortages, including rebuilding U.S. domestic production of essential medicines. Some proposals have already been put forward on this front, with Iacovella referencing a bill offered up by Senate Majority Leader Chuck Schumer, (D-N.Y.), last year to incentivize generic manufacturing in the U.S. The four-point plan would seek to ensure drugmakers are providing transparency around shortages and require them to report safety issues, where they source raw materials and when demand is overriding supply. The plan would also aim to make sure there are enough manufacturers producing generic drugs; improve production safety and quality; and incentivize domestic manufacturing and onshoring. “It creates a series of vulnerabilities and problems when the country’s generic drug market is so reliant on foreign actors,” Schumer noted in a statement at the time.

The average drug shortage duration is now over three years, compared to only two years in 2020. By Lecia Bushak Amid record volumes of drug shortages in the U.S., it appears the shortages are lasting longer year-over-year, according to a US Pharmacopeia (USP) report. The USP Annual Drug Shortages Report, released this month, examined the impact and economic factors of drug shortages throughout 2023. Its goal: To provide policymakers and industry leaders with “data-driven insights to shape policies and investments to prevent and mitigate future drug shortages.” The average drug shortage duration is now over three years, compared to two years in 2020, the report found. The average duration lasted 1,202 days as of December 2023, compared to 706 in 2019. The sturdy also highlighted that generic injectables are often most at risk, with 53% of new shortages affecting those types of medicines. Using data from USP’s Medicine Supply Map, the report  pinpointed a “severe risk of shortage” for 91% of generic sterile injectable shortages in 2023. 2024 has already seen the highest number of active drug shortages since 2001, with 323 medicines affected, according to the American Society of Health-System Pharmacists. The shortages haven’t discriminated when it comes to the therapeutic area: oncology, psychiatry, cardiovascular, gastroenterology and a number of other areas have been impacted. But sterile injectables are “particularly vulnerable to supply chain disruptions when compared to solid oral dose medications because of their increased manufacturing complexity,” the authors wrote. Unsurprisingly, lower-cost generics – which are more likely to be discontinued by manufacturers, due to a lack of incentives to produce them – have a higher risk of shortfalls. The average unit price for injectables in shortage was $46, compared to $392 per unit for those that weren’t in shortage. This also affected solid oral drugs, with the average price of those in shortage being $3.4 per unit compared to $17.5 per unit. That’s a “significant difference in cost,” which “stems from the wide spectrum of drug products and their manufacturing complexities,” the authors wrote. Discontinuation of drug products rose by 40% in 2023, the report found, from 100 drugs in 2022 to 140 in 2023. That’s the highest rate of discontinuation since 2019. Nearly half of the products discontinued in 2023 were priced lower than $4. “The lack of a financial incentive to produce a less profitable drug constrains supply and can also create the opportunity for manufacturers to discontinue products, which can lead to or exacerbate a drug shortage,” the authors noted. Complex vulnerabilities, as well as slowdowns and problems in Food and Drug Administration inspections, prevent the pharmaceutical supply chain from being resilient, the authors added. A lack of transparency into the supply chain “makes it difficult to gain a consistent, reliable and adequate view of the supply of a drug,” they wrote. The authors urged lawmakers to craft policy that incentivizes a “high-quality and adequate supply chain that differentiates suppliers based on reliability and resilience.” Lawmakers have increased the heat on the pharma industry in recent months. In February, a group of Democratic lawmakers sent letters to several Big Pharma companies, including Pfizer and Teva Pharmaceuticals, to underscore the importance of solving the shortages, especially for life-saving cancer drugs like cisplatin.

The Association of Health Care Journalists compiled a list of tips, story angles and resources for reporters who are covering the ongoing drug shortages. By Lecia Bushak As drug shortages continue at a historic high – with more than 300 medications currently in deficit – the Association of Health Care Journalists (AHCJ) has released a tip sheet for reporters covering the issue. In a recent blog post, the AHCJ pinpointed several of the causes of the shortages and provided journalists with various tips for story ideas as well as resources for how to find expert sources that can assist them in their work. AHCJ noted in its post that journalists could examine the angle of how the shortages are affecting patients as they search different pharmacies for available medications, ration doses or even live without their medications for weeks or months. “You could also look into the reasoning behind shortages, in particular drug classes and what needs to happen to try to mitigate those situations, and report on proposed policy fixes and how those could help,” AHCJ continued. The organization provided a list of possible expert sources, including Erin Fox, PharmD, MHA, BCPS, FASHP, associate chief pharmacy officer for shared services at the University of Utah; Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP; and Julie Gralow, MD, FACP, FASCO, chief medical officer and EVP of the American Society of Clinical Oncology (ASCO), among others. The post also included links to previous news coverage, as well as resources like ASHP’s Current Drug Shortages database and the Senate Finance Committee’s May 2024 draft legislation that would tackle shortages. The AHCJ post comes amid a worsening situation for access to prescription drugs. In April, the American Society of Health-System Pharmacists (ASHP), which tracks drugs in shortage, released a report noting that shortages had reached a record high of 323 medications affected. That surpassed the previous record-high of 320 in 2014. “All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz wrote in a blog post at the time. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas.” He added that the ongoing shortages for ADHD drugs “remain a serious challenge for clinicians and patients.” The issue has reached such a breaking point that it’s attracted attention from lawmakers in Congress. In February, a group of Democratic lawmakers led by ranking member of the House Oversight and Accountability Committee, Rep. Jamie Raskin, (D-MD), sent letters to major drugmakers including Pfizer, Sandoz and Teva Pharmaceuticals to call on them to address the issue. The letters highlighted amoxicillin, a penicillin antibiotic – as well as cancer drugs like carboplatin and cisplatin as being in short supply, which has resulted in oncology practices having to ration doses and even curtail patients’ treatments. Months later, the shortages continue. Fox, the University of Utah leader, told AHCJ that it’s concerning that the problem isn’t getting better. As such, journalists will likely need to cover the story for the long-term – and from a variety of different angles. The factors driving the shortages are varied, and include issues like a lack of incentives for generics production in the U.S. or the Food and Drug Administration being behind on manufacturing inspections since the COVID-19 pandemic.

As shortages continue to affect obesity drugs like Ozempic and Wegovy, telehealth company Ro launched a GLP-1 Supply Tracker to help patients fill prescriptions. By Lecia Bushak As obesity drugs continue to face shortages and patients scramble to fill prescriptions, telehealth company Ro has launched a tracker that monitors GLP-1 supply. The GLP-1 Supply Tracker aims to provide patients with real-time data on shortages affecting GLP-1 drugs like Ozempic and Wegovy, as well as supply alerts specific to patients’ geography. Shortages are currently affecting a record number of medications in the U.S. and semaglutide injections have been listed as being in shortage on the Food and Drug Administration’s website since March 2022. Currently, the 0.25 mg, 0.5 mg and 1 mg doses of Wegovy are listed as being in shortage on the FDA’s tracker due to a record-high demand increase for the drug. As a result, many patients across the U.S. have struggled to find pharmacies that can fill their GLP-1 prescriptions and some have had to either stop treatment entirely or pursue questionable medical options. Part of Ro’s reasoning behind launching the GLP-1 Supply Tracker is to provide patients with more live information about where they can go to fill prescriptions. The tracker updates in real-time based on patients submitting reports. The Supply Tracker consists of a reporting section where patients can submit information about shortages at specific pharmacies or list the drug, dose and pharmacy where they found available supply. Ro then provides an option to report shortage information to the FDA, “with no additional steps required,” the company noted. The tracker also includes the option for patients to sign up for automated email alerts that are sent out when a GLP-1 drug becomes available in their area. The alerts include the pharmacy’s name, address and phone number. “The GLP-1 shortage challenges are exacerbated by a lack of accurate, up-to-date, and accessible GLP-1 supply information,” said Zachariah Reitano, co-founder and CEO of Ro, in a statement. “Patients deserve better.” The company also noted that the platform will be free and available for any patient or healthcare provider who’s interested. In light of these lingering shortages, major obesity drugmakers like Eli Lilly and Novo Nordisk have recently sought to boost manufacturing for the drugs. Novo Holdings, Novo Nordisk’s parent company, bought Catalent for $16.5 billion earlier this year in an effort to increase Wegovy production; and it’s spending $8 billion to expand a plant in Denmark. Meanwhile, Lilly just earmarked another $5.3 billion to boost production of its GLP-1 drugs Mounjaro and Zepbound. In the meantime, patients can now use Ro’s GLP-1 Supply Tracker to receive more up-to-date information about supply.

Some ADHD drugs are back in supply following months of shortages, FDA says

Teva Pharmaceuticals appears to have replenished most of its Adderall shortages, except for a 5 mg dose, which it says will be resolved by June. By Lecia Bushak Some drug manufacturers of attention-deficit/hyperactivity disorder (ADHD) drugs have replenished their supply after battling shortages for months, according to the Food and Drug Administration’s database. The FDA’s online drug shortage database now notes that nine manufacturers of ADHD drugs have those medications back in supply, including Teva Pharmaceuticals. That’s a slight improvement from last fall, when only six manufacturers listed all their ADHD drugs as available. A search for amphetamine – a stimulant used in Adderall and the generic versions of Adderall – on the FDA database shows that all doses of Alvogen Pharma, Sandoz and Elite Laboratories’ ADHD medications are now available. Teva, meanwhile, appears to have resolved most of its Adderall shortages, with all doses except a 5 mg version now available. The pharma giant projected that the shortage of the 5 mg dose will be resolved in June, noting that it is manufacturing and distributing “consistent with historic levels” amid unprecedented demand. Aurobindo Pharma also continues to face shortages with an estimated availability of September. The ADHD drug shortage, which has plagued the U.S. since 2022, affects the 8 million people living with ADHD in the U.S. by making it difficult to get prescriptions filled. Patients have taken to TikTok and social media to portray how the shortages have impacted their daily lives, schoolwork and careers. “Since not being on my meds, I have been… doing some stuff,” TikToker Sarah notes half-jokingly in one recent video. “Let’s look at what I’ve been doing – or not doing. First we have this super random, impulsive bathroom renovation going on. Oh look, it’s my computer under a pile of clothes that I need to [use] to do the schoolwork that I’m not doing… Send help.”

@sarahvaught23 Its the last one for me. I feel like its self explanatory #adderalshortage #adhd #adhdtiktok #fyp ♬ Funny – Gold-Tiger

Another TikToker who considers herself a mental health advocate, Naomi Makessa, posted a video recently that shows what it’s like for a person with ADHD to be told by their pharmacist that their medication is not in stock. “I don’t know what I’m going to do,” she says in the video as she starts crying. “Because I need my meds. I don’t know what I’m going to do.” The video then shows her struggling to clean or get through the school day.

@naomimakessa #adhd #adhdtiktok #adhdmeds #adhdmedshortage #adderral #dexedrin #conserta #vyvanse #ritalinn #focalin #neurospicy #neurodivergent #adhdmedicine #adhdmedication #adhdadult #adhdinwomen #adhdblackwomen ♬ original sound – Nae | Mental Health Artist

While it appears the ADHD shortage is showing signs of letting up, the FDA noted that it’s still working to address the limited availability of the drugs still in shortage. “The public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” an FDA spokesperson told NBC News. The return of some ADHD drugs to availability comes several months after lawmakers in Congress put the spotlight on Big Pharma companies, calling on them to address the ongoing shortages. A group of Democratic lawmakers, led by Rep. Jamie Raskin (D-MD), sent letters to Pfizer, Sandoz and Teva Pharmaceuticals requesting the companies take action to boost availability of the drugs, which include chemotherapy drugs, amoxicillin and ADHD drugs.

As major obesity players aim to boost manufacturing to meet high demand for GLP-1 drugs, Eli Lilly is looking ahead to a pill version of the drug that’s currently in a Phase 3 trial. By Lecia Bushak The demand for GLP-1 drugs like Ozempic and Zepbound is so high that the introduction of a pill form of these drugs would need to be developed in order to ease shortages, an Eli Lilly executive told Quartz this week. Nearly all doses of Lilly’s weight loss drugs Zepbound and Mounjaro, which are injections, are currently listed as being in shortage — with limited availability expected through June, the pharma giant stated. Currently, only the 2.5 mg versions of both are available for now. Similarly, Novo Nordisk’s injectable GLP-1 drugs Ozempic and Wegovy have faced shortages since 2022, amid a nationwide drug shortage crisis that is affecting more than 300 medications. The limited availability of the weight loss pills is largely driven by unprecedented demand, as more than 40% of Americans are currently living with obesity. In a recent interview with Quartz, Patrik Jonsson, Lilly’s president of diabetes and obesity, suggested that a new weight loss pill would need to get on the market to ease the existing shortages. “Even if we take the combined supply of our [medications] and the competition, it’s not sufficient to meet the needs of 110 million Americans,” Jonsson told the outlet. Lilly has sought to bolster its manufacturing facilities through $3 billion in investments over the last two years. The company has also said that it expects to double its incretin capacity in the second half of 2024 compared to the second half of last year. Despite all of these efforts — including a new facility in North Carolina that will focus on incretin production — the supply is not enough to meet the demand, according to Jonsson. “We will continue to increase supply, but taking into account the huge need, there would probably continue to be supply constraints until we had an oral medicine with an injectable-like efficacy,” Jonsson continued. Lilly is currently in the process of investigating such a pill, known as orforgilpron, which led to 14.7% weight loss at 36 weeks in a Phase 2 trial. The pill, which will still need to show efficacy in a Phase 3 trial, could be a more convenient option for some patients who are hesitant to use injectables. Jonsson has said in previous statements that “it’s impossible to reach all [of those patients] with injectables,” and “I think that’s the big opportunity we have for orforgilpron.”

The nation’s ongoing drug shortages have forced leaders on Capitol Hill to act. By Jack O’Brien A bipartisan pair of senators proposed a voluntary Medicare provider incentive program to curb the nation’s ongoing drug shortages. Senate Finance Committee Chair Ron Wyden, (D-Ore.), and ranking member Mike Crapo, (R-Idaho), unveiled the draft legislation last week that would establish a new Medicare program for provider organizations and physicians to encourage “transparent, reliable, and resilient purchasing practices” Specifics for the proposed program include minimum three-year contracts with generic manufacturers present high shortage risks, purchase volume commitments and stable pricing measures, contingency contracts requirements with alternate manufacturers and a ban on exclusive contracting requirements for providers. Wyden and Crapo also proposed changes to the Medicaid Drug Rebate Program to allow for reductions or waivers to the inflation rebate for certain generics in the event of shortages. Wyden said in a statement that America’s continued lack of affordable, essential generic medicines is unacceptable and pinned blame on “monopolistic middlemen.” “Our bipartisan proposal uses the power of Medicare and Medicaid to ensure the entire American health care system has adequate supply for key medicines across the country,” he stated. “Middlemen like GPOs should not be able to do business with Medicare if their contracting practices are actively worsening the drug shortage challenge in America.” Crapo added that the pair are eager to work with the rest of the Senate Finance Committee to advance the bill to the floor.

The 1.7 mg dose of Novo Nordisk’s Wegovy is now available, but smaller doses remain in limited supply as high demand continues. By Lecia Bushak Even as the U.S. reached a record high in drug shortages last month, one dosage of Novo Nordisk’s GLP-1 drug Wegovy has returned to availability. The 1.7 mg dose of Wegovy is now listed as available on the Food and Drug Administration’s website, which means two doses – this one and the 2.4 mg dose – are no longer officially in shortage. Smaller doses, however – including the 1 mg, 0.5 mg and 0.25 mg, remain in limited supply. Novo Nordisk said it has been working to replenish supply of Wegovy and its other GLP-1 drug, Ozempic, as the pharma giant faces shortages amid high demand. Even though the 1.7 mg dose is currently being listed as available, Novo has warned that continuing high demand may make it difficult for some patients to fill their prescriptions. “Novo will continue to follow its plan to gradually increase overall supply throughout the rest of the year, but it’s important to recognize that overall demand will continue to exceed supply,” a spokesperson told Reuters. “This means that some patients may still have difficulty filling Wegovy prescriptions.” Novo has a dedicated page on its website to updates about Wegovy, noting there that it’s made significant investments and has increasing capacity to produce more quantities of the drug. The Danish drugmaker noted it had started doubling the amount of the lower dose strengths of Wegovy into the U.S. market starting in January. Plus, in February, Novo’s parent company Novo Holdings acquired Catalent in a $16.5 billion deal to increase Wegovy production. Other popular weight loss and diabetes drugs, including those manufactured by Eli Lilly, are also currently facing shortages. Most doses of Lilly’s Zepbound and Mounjaro are listed as being in shortage according to the FDA, with limited availability expected through the second quarter of the year. For now, just the 2.5 mg versions of both Zepbound and Mounjaro remain available.

The parma giant said nearly all doses of Zepbound and Mounjaro will be in limited supply until early summer. By Lecia Bushak Eli Lilly’s weight loss drugs Zepbound and Mounjaro will face shortages through June as demand remains high. The Food and Drug Administration has listed most doses of Zepbound — the GLP-1 drug was approved in late 2023 as an obesity treatment — as being in limited supply through the second quarter of this year. Nearly all doses of Mounjaro, a type 2 diabetes treatment, are also listed as being in short supply. The 2.5 milligram versions of both Zepbound and Mounjaro remain available for now, according to the FDA. Patients taking Zepbound have flocked to TikTok in recent days to complain about the impact of the shortages on their weight loss journeys. The shortages mean patients’ treatment plan can be disrupted as they search for pharmacies that stock their doses. “National shortage — can’t get it,” one TikToker says in a video, talking about her Zepbound prescription. “I’ve been really adhering to my low carb, high protein, and really trying to refrain from my recreational drinking. But I’m terrified of the food noise coming back… All we can do is just wait, and hopefully they get it restocked soon.”

@ohgeemiranda1 Scared but staying postitive #zepbound #tirzepatide #mounjarojourney #weightloss #shortage #weightlossprogress #weightlosscheck ♬ original sound – Miranda Dean

@shutupsam39 One more week until my local phǎrmacies hate me 🙂 #zepbound #glp1 #nationalshortage #weightloss ♬ original sound – lolno

“We recognize this situation may cause a disruption in peoples’ treatment regimens and are working with purpose and urgency to help meet the surge in demand,” an Eli Lilly spokesperson told CNBC. The company added that it was banking on its recent investments in manufacturing capacity to progressively increase production of its medicines throughout 2024. Last year, Lilly invested $450 million into its North Carolina facility, Research Triangle Park, aiming to boost manufacturing for all of its diabetes products. Trulicity and Mounjaro have faced shortages since 2022, driven largely by high demand for the medicines. At the time, Lilly noted that it planned to double its incretin capacity by the end of 2023. The pharma giant said that it was also in the process of developing a new plant in North Carolina that will focus on incretin production, with the goal of shipping products by 2025. Other players in the obesity space, such as Novo Nordisk, have made similar moves in the last year to increase production amid soaring demand. In February, Novo Holdings acquired Catalent in a $16.5 billion deal, with the plan of selling Novo Nordisk three of the company’s fill-finish sites to boost manufacturing. At the time, the drugmaker noted the addition of the three sites was part of its aim to reach “more people living with diabetes and obesity with current and future treatments.”

More than 300 medications are currently in shortage in the U.S. — the highest level ever recorded. By Lecia Bushak Drug shortages in the U.S. have reached a record high — with 323 medications currently in shortage, according to a recent report out of the American Society of Health-System Pharmacists (ASHP). That eclipsed the previous record-high of 320 in 2014. ASHP noted that drug shortages had reached their highest level since the University of Utah Drug Information Service began tracking the data in 2001. Cancer drugs, obesity drugs like Ozempic, amoxicillin and attention-deficit/hyperactivity disorder (ADHD) medications have all been impacted during this current streak of shortages, which has gradually been increasing since 2021. Other classes of drugs affected include central nervous system (CNS) drugs, antimicrobials and hormone agents. There have been reports of healthcare providers having to ration or substitute drugs to treat patients, as well as patients with ADHD having to drive hours to find a pharmacy to fill their Adderall prescriptions. The most “worrying” shortages are affecting generic sterile injectable drugs, such as chemotherapy drugs, ASHP CEO Paul Abramowitz wrote in a recent blog post. Many of the drugs in shortage are generic medications. While a variety of factors contribute to drug shortages, experts say the fragility of the pharmaceutical supply chain, specifically when it comes to generics, plays a big role. Pharma companies are less incentivized to manufacture less expensive generic drugs, making them more at risk of shortages. Food and Drug Administration Commissioner Robert Califf highlighted the issue in a fireside chat earlier this year, calling it an “economic failure.” “You don’t have to be a business genius to figure out why that’s happening,” he said, adding that it was “a system that’s fundamentally broken.” Earlier this month, the Department of Health and Human Services released a report outlining policy considerations that would help mitigate supply chain vulnerabilities and prevent drug shortages. The paper called for building “supply chain resilience” by boosting the diversification of supply and ensuring efficient manufacturing practices. However, Abramowitz noted in the blog post that ASHP has “serious concerns” about HHS’ proposed financial penalties for hospitals and urged the agency to take other suggested steps to mitigate shortages. Abramowitz called on policymakers to fix the root causes of the drug shortages. Other drugs, in particular GLP-1s, are experiencing shortages due to unprecedented demand in recent years. In a statement on April 2, Eli Lilly noted that all doses of its type 2 diabetes drug Mounjaro would be in limited availability until the end of August, and that the supply situation “is due to larger than expected demand.” Lilly urged healthcare providers to “consider the impact of limited product availability on patients when making treatment choices, particularly for new patient initiations.” The pharma added it was committed to future replenishment of all doses of Mounjaro.

Adderall prescription fills plummet 11% amid shortage

The rate of people filling their Adderall prescriptions has declined as drug shortages persist, leaving many patients without access to necessary medication. By Lecia Bushak The rate of people filling their Adderall prescriptions fell by 11% between the first half of 2022 and the first half of 2023, according to a recent data analysis from Truveta and CNN. The drop in prescriptions getting filled is linked to the broader Adderall shortage, which the Food and Drug Administration officially announced in October 2022. When researchers adjusted for age, they found that adults over the age of 18 had a higher average fill rate than adolescents under the age of 18. However, adults also saw a bigger drop in fills between January and May 2022 and the same time period of 2023. Adderall, which is a combination drug of amphetamine and dextroamphetamine, is used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy.  In ADHD patients, Adderall boosts dopamine and norepinephrine in the brain, which can improve focus and attention, as well as alleviate anxiety. The report examined more than 336,000 people who had an ADHD diagnosis as well as an Adderall prescription fill between 2016 and 2023. The data is preliminary and has not been peer-reviewed. The researchers found that the rate of first time Adderall prescriptions began steadily declining after a peak rate of 7% in March 2022 – and has not returned to pre-shortage levels yet. Since shortages have affected Adderall as well as Vyvanse, patients with ADHD have been struggling to stay medicated – and sometimes even function in their day-to-day lives. Scores of people have complained about the problem on social media, particularly TikTok, noting they have been unable to get their prescriptions filled at the pharmacy or have been forced to ration their doses.

@livingwith.adhd

Is anyone else struggling to get their ADHD medication?? Its so annoying having to case after it every month 😭 #adhd #adhdmedication

♬ original sound – Beth | ADHD 🧠

In one video, a TikToker describes having to drive two hours to find a pharmacy that could fill her prescription following a two week delay. Dr. David Goodman, assistant professor in the department of psychiatry and behavioral sciences at the Johns Hopkins School of Medicine, told CNN that being unable to fill prescriptions for ADHD can leave patients losing track of school, work or daily chores. “It would be like ordering glasses and not being able to get them for months,” he told CNN. “I mean, how are you going to function in the world without your glasses?” The shortage is especially pertinent given that ADHD prescriptions for drugs like Ritalin and Adderall surged during the COVID-19 pandemic, with women and young people seeing the highest increases, according to a study released in January.

Bloomberg noted that while the FDA doesn’t list Zepbound as being in short supply and Lilly has said its available to pharmacies through their wholesaler, multiple pharmacies have complained about shortages of all or some dosages. By Jack O’Brien It’s no surprise that Eli Lilly’s obesity drug Zepbound is a hot commodity. However, it’s such a hot commodity that Amazon and Rite Aid can’t keep their supplies of the drug up enough to meet demand, according to a report from Bloomberg Thursday afternoon. The outlet noted that while the Food and Drug Administration doesn’t list Zepbound as being in short supply and Lilly has said its available to pharmacies through their wholesaler, multiple pharmacies have complained about shortages of all or some dosages. Four doses of Zepbound are listed as unavailable on Amazon Pharmacy and a company spokesperson told Bloomberg that there is a nationwide shortage of weight loss drugs. Meanwhile, Rite Aid told MT Newswires that Zepbound has had some “sporadic supply constraints” due to high demand. “We continue to communicate and work with our suppliers to mitigate where possible,” the company added. Since the GLP-1 revolution kicked off in earnest at the end of 2022 and throughout last year, Zepbound, its diabetes drug counterpart Mounjaro and rivals from Novo Nordisk – Wegovy and Ozempic – have routinely been in short supply due to widespread off-label use for weight loss. In February, the FDA’s drug shortage website identified 10, 12.5 and 15 mg doses of Mounjaro as being in short supply through March. Lower doses of the drug, however, remained available. However, it’s worth noting that these reported shortages come as Lilly aims to improve access to its GLP-1 drugs. A few weeks ago, Lilly announced that it partnered with Amazon to distribute select medications through the drugmaker’s telehealth offering LillyDirect. Through this partnership, physicians can send prescriptions to either LillyDirect Pharmacy Solutions or to Amazon Pharmacy and they will be delivered to a patient’s home. As the drugs have received unprecedented consumer demand, they have bolstered Lilly’s bottom line. Last quarter, Mounjaro’s revenue topped $2.2 billion, up from $279 million in Q4 2022, while Zepbound generated nearly $176 million in its first quarter on the market. Additionally, Amazon launched same-day delivery of prescription medications in New York City and the greater Los Angeles area just this week.

A group of bipartisan Senators have asked the Department of Defense to provide an update on the pharmaceutical supply chain amid drug shortages. By Lecia Bushak More than a quarter of drugs listed as essential medicines by the Food and Drug Administration are categorized as “very high risk” when it comes to drug security, according to a recetnly report released by a group of bipartisan senators. The report, conducted last year by the Under Secretary of Defense for Acquisition and Sustainment, examined risks linked to the Department of Defense’s pharmaceutical supply chain. Being “very high risk” means the drugs face quality issues linked to their sources, active pharmaceutical ingredients (APIs) and key ingredients — and are entirely manufactured overseas in China or India, where U.S. regulators have struggled to keep up with inspections in recent years. A group of bipartisan Senators including Elizabeth Warren, (D-MA), Marco Rubio, (R-FL), and Richard Blumenthal, (D-CT), sent a joint letter to the Department of Defense requesting information about the military’s efforts to address the serious issues in the pharmaceutical supply chain. The letter comes amid widespread drug shortages that have impacted medications from attention-deficit/hyperactivity disorder (ADHD) drugs to chemotherapy treatments. In 2023, drug shortages reached the highest level in nearly a decade. “While there are several causes of drug shortages, supply chain disruptions due to quality failures are a growing concern,” the senators wrote in the letter. “In many cases, only a handful of pharmaceutical companies manufacture a particular generic drug. When these companies experience quality concerns or manufacturing challenges, there is enormous strain placed on the supply chain, leading to widespread disruptions.” The letter noted that 58% of drug manufacturers that made drugs for the U.S. market were based overseas in 2022, exposing the drug supply chain to potential safety risks, given that domestic regulators have a reduced ability to conduct oversight in India, China and other foreign countries. The report categorized drugs in a hierarchy of drug security, with the most secure drugs being manufactured entirely in the U.S., using domestic APIs/ingredients. One-quarter of drugs on the essential medicines list were ranked as most secure. Moderately secure drugs are manufactured in Canada and Mexico, and those at moderate risk are Trade Agreement Act (TAA) compliant. High risk drugs are manufactured by non-TAA compliant sources. Those categorized as very high risk are 100% dependent on Chinese manufacturers, using only Chinese APIs/ingredients, the report said. The senators’ letter pointed to tacrolimus — a drug used in organ-transplant patients and veterans who had lost a limb — as being one example of the negative impact supply chain issues were having on patients. One of the generics of tacrolimus, manufactured in India by pharma company Intas Pharmaceuticals, proved to be less effective than the brand-name version of the drug — and in some cases, was even dangerous, causing kidney failure and seizures in some patients, according to a report by Bloomberg. “We appreciate DoD’s attention to these important matters and look forward to strengthening the resilience of our pharmaceutical supply chain,” the letter concluded. The group of senators have asked the Department of Defense to provide answers to several questions by April 1. This includes describing the steps that the agency has taken to assess the pharmaceutical supply chain risks and identify those that are “most critical to beneficiary care at military treatment facilities.”

Mark Cuban Cost Plus Drug Company will begin selling generic injectables to CHS to jumpstart its mission of easing nationwide drug shortages.

by Lecia Bushak Mark Cuban Cost Plus Drug Company struck a partnership with Community Health Systems (CHS) to sell its generic medications to the nationwide health system amid ongoing drug shortages. Cost Plus Drug Company launched in early 2022 with the goal of offering generic drugs at cheaper costs and skipping middlemen known as pharmacy benefit managers (PBM). The partnership with CHS will initially involve Cost Plus Drugs providing epinephrine and norepinephrine — injectables that are typically used to treat life-threatening conditions, from allergic reactions to cardiac issues.  Currently, epinephrine is listed on the Food and Drug Administration’s drug shortages website. In a press release, CHS noted the partnership will focus on several goals including lowering the cost of drugs, manufacturing medications that are on the shortages list, reducing pharmaceutical waste and preventing dosing errors. “This partnership has the potential to shine a light on all of the ways cost Plus Drugs can work with like-minded providers to create a better approach to drug delivery in hospitals and in multiple care delivery environments,” Cost Plugs Drugs CEO Alex Oshymansky said in a statement. Lynn Simons, president of healthcare innovation and chief medical officer at CHS, added that the two companies plan to disrupt the way providers purchase products and services. CHS-affiliated hospitals in Texas and Pennsylvania will be the first to buy the drugs from Cost Plus Drugs, with the goal of expanding the partnership throughout CHS’ 70 acute care hospitals and locations. The partnership comes shortly after Cost Plus Drugs announced it would begin manufacturing its own generic drugs.  Earlier this month, a roundtable at the White House featured Federal Trade Commission chair Lina Khan, Mark Cuban and Oshymansky, among others, who discussed price transparency as well as the potential impact Cost Plus Drugs will have on the industry. Oshymansky noted that Cost Plus Drugs will initially manufacture epinephrine and norepinephrine for ICU patients, then build up to making pediatric chemotherapy treatments.  The company’s new $11 million fill-and-finish facility in Dallas will serve as its manufacturing location, with the goal of easing drug shortages. Currently, Cost Plus Drugs offers 2,500 generic drugs through its online pharmacy, with Cuban noting in a recent interview with CNBC that the company has “probably a couple million patients now.” “[W]e’re setting records almost every single week,” Cuban noted in the interview. “We’re about to open up our manufacturing plant this week, where we will be releasing sterile injectables for generics that are on short supply.” Cuban said the company plans to meet the demand of shortages through its robotically-driven production line, which it plans to expand so that “over the next five years, there will no longer be any more shortages in sterile injectables.” Cuban did note, however, that the company was not making money yet. “But that’s OK,” he said. “We’re changing an industry, we’re saving patients.”

The CDC has updated its guidance on the tetanus and diphtheria (Td) vaccine after MassBiologics announced it would discontinue the shot, noting it will be in limited supply.

by Lecia Bushak Recently, drug shortages have been hitting the U.S. hard, with shortages affecting cancer, attention-deficit/hyperactivity disorder (ADHD) and GLP-1 drugs. Now, the U.S. can also expect limited supply of tetanus shots moving forward, according to the Centers for Disease Control and Prevention (CDC). The CDC recenlt updated its guidance on the tetanus and diphtheria (Td) vaccine, or TdVax, noting that its manufacturer, MassBiologics, has discontinued the shot. As a result, the agency expects the supply of the vaccine to be limited throughout 2024. Tetanus, also known as “lockjaw,” is a bacterial infection caused by Clostridium tetani, which produces a toxin that triggers painful muscle contractions. Tetanus spores are typically found in the environment — in dirt, dust and manure — and humans can get infected through broken skin. TdVax was historically one of two Td vaccines available in the U.S., with the second one — Tenivac — manufactured by Sanofi. Since the discontinuation of TdVax, Sanofi has said it will take steps to boost its supply of Tenivac. “Temporary ordering controls are in place in the public and private sectors to help manage the gap in supply,” the CDC noted. Tdap vaccines, which cover diphtheria, tetanus and acellular pertussis, remain available. In its guidance to physicians, the CDC said that what remains of the limited Td supply should be preserved for patients who cannot receive the Tdap vaccine. In most other cases, physicians and pharmacists can administer the Tdap vaccine instead of the Td shot. “Tdap vaccine is an acceptable alternative to Td vaccine, including when a tetanus booster is indicated for wound management,” the CDC stated. “This guidance will remain in place until the period of temporary ordering controls for Td vaccine ends.” The latest Td shot supply block is shadowed by the larger drug shortage issue — which has impacted hundreds of medications, including chemotherapy drugs like cisplatin.  The issue has snowballed into an increasingly complex supply chain issue, with many hospitals and physicians rationing doses to patients or delaying treatment entirely. In response, a group of Democratic lawmakers has been calling on Big Pharma companies to address the shortages.  Last week, policymakers led by ranking member of the House Oversight and Accountability Committee, Rep. Jamie Raskin (D-MD), sent letters addressed to Pfizer, Sandoz and Teva Pharmaceuticals urging the drugmakers to produce more generic drugs.

A group of House Democrats called out three Big Pharma companies to address nationwide drug shortages impacting cancer, ADHD and antibiotic drugs.

by Lecia Bushak A group of Democratic lawmakers are calling on Big Pharma companies to address U.S. drug shortages – which are impacting hundreds of medications from chemotherapy treatments to mental health drugs. Led by ranking member of the House Oversight and Accountability Committee, Rep. Jamie Raskin, (D-MD), a group of Democrats sent letters to Pfizer, Sandoz and Teva Pharmaceuticals last week detailing the impact of shortages on patients and hospital systems — and requesting the pharma companies to take action. The letters pinpointed various cancer drugs — including carboplatin and cisplatin — that are in shortage, as well as amoxicillin, a penicillin antibiotic. They also highlighted attention-deficit/hyperactivity disorder (ADHD) drugs like Adderall, that currently face shortages, arguing there was an “urgent need” to boost their supply. In a letter addressed to Pfizer CEO Albert Bourla, the lawmakers emphasized that while the U.S. has experienced cancer drug shortages in the past, the current one is “particularly acute,” with the majority of hospital systems negatively impacted last year. “[I]n many instances, oncology practices were forced to ration doses or provide less desirable alternatives to a patient’s recommended treatment,” they wrote. The lawmakers also highlighted one of the root causes of generic drug shortages: Pharma companies have less financial incentive to manufacture enough generic drugs that are often sold at a cheaper cost than branded medications. Some manufacturers have even discontinued generic drug production due to lack of profitability. “It is extremely concerning that pharmaceutical companies may not be motivated to produce generic drugs like carboplatin, cisplatin, and methotrexate, because they are not as lucrative as producing patented brand name drugs,” the letter stated. “As a principal supplier of carboplatin, cisplatin, and methotrexate, it is critical that Pfizer continues to increase production of these life-sustaining cancer medications, even amidst potential lower profitability.” In another letter, this time to Sandoz, the lawmakers argued that parents and children depend on amoxicillin to treat a variety of childhood illnesses that can range in terms of severity from mundane to life-threatening. Additionally, antibiotics like amoxicillin are 42% more likely to experience shortages compared to other prescription medications, the lawmakers added. Finally, the lawmakers’ letter to Teva outlined the need for ADHD drugs that are currently in shortage. “[P]reviously capable students are now barely able to get passing grades, and adults are forced to contact every local pharmacy in an attempt to obtain a medication that may be the difference between being productive and focused in the workplace or losing their livelihoods,” they wrote. The letters requested information from the three pharma companies on the steps they are taking to address the current shortages as well as to prevent future shortages. The lawmakers have asked the pharma companies to provide responses by March 6.

People are flocking to TikTok to discuss, commiserate and share tips on accessing crucial treatments.

by Lecia Bushak The U.S. continues to face shortages of hundreds of drugs, from life-saving chemotherapy drugs to popular weight loss meds like Wegovy, and those shortages are expected to extend into 2024. In response, patients who are struggling to get their prescriptions filled are banding together on TikTok to discuss, commiserate, offer tips and figure out how to live without crucial medications.

@philsmypharmacist Good luck trying to find your ADHD medication. Supply chain and inflation gonna get you #adhd #neurodivergent #trump #biden #support #medicine ♬ original sound – Philsmypharmacist

Videos about the shortage of ADHD drugs, including Vyvanse and Adderall, are popular on TikTok. In clip after clip, people complain that they can’t get their ADHD prescriptions filled for months. Others say they’ve been switched to a different drug or manufacturer, and the treatments simply aren’t working for them. “If you are seeing this video, you may or may not be an ADHD girlie in bed, in near tears, with your tea and emotional support penguin, over the Vyvanse shortage,” one TikTok user said.

@beccas_version If you’re someone with #ADHD struggling with the medication shortages right now, you are not alone. I have been tracking the Vyvanse shortage ever since I was originally perscribed it. While there is no one entity or issue fully to blame as it’s a complex issue, it’s frustrating that this has yet to be solved. While there are so many pressing issues right now in health care and beyond, this is impacting millions of people with no end in sight. I’ll post an update video if and when new updates come out. #adhdtiktok ♬ original sound – Becca Morgan

“You know the feeling of rationing your medication, forgetting to refill your medication because you’ve been rationing your medication, and the medication helps you remember to do stuff, but you don’t have the medication so you don’t remember to fill the medication?” TikToker Alexis Amber said half-jokingly in a video.

@daiquiriheiress #medicationshortage #adhd #imso ♬ original sound – alexis amber

Other videos show people with ADHD jumping around instead of focusing, or others lying in bed unable to function. Commenters echo those concerns: They can’t access their medications and it’s impacting their ability to function. “I am scared,” one commenter wrote. “I was so close to having a full on life breakdown before I was finally diagnosed. I will 100% lose my job and sanity if I can’t get meds.” “I’m literally trying so hard not to cry because my meds are all out of stock,” another commenter added. “They keep me normal. I literally have trouble driving without them.” “The shortage caused me to drop out of college,” a third commiserated. “Finals week without my meds was my last straw.”

@stringshredder Starting to regret not getting that DSR form! #adhd #adhdmeds #mentalhealth #neurodivergent #neurotypical #neurospicy #adhdtiktok ♬ Elevator Music – Lesfm

The problem has led many people to turn to the app to seek out alternatives. “It’s really concerning and a huge problem for a lot of adults,” Sarah Al Potter explained in one video. “I no longer take ADHD medication because I started experiencing shortages, and I was like, ‘No, I have to function. I have to find an alternative here.’” “There should not be a shortage of any kind of mental health medication out there because people like me — neurodivergent people, autistic people, people with bipolar disorder. We need these medications in order to thrive, survive and continue to live a productive life,” she added.

@sarahalpotter #stitch with @find_your_magic the #adhdprobs currently going on with #adhdmeds #medication #adhdtiktok #adhd #adhdtiktokcommunity #adhdtiktoker #adhdtiktoks #adhdinwomen ♬ original sound – Sarah Al Potter

But ADHD drugs aren’t the only medications impacted by shortages and manufacturing backups. According to the Food and Drug Administration’s drug shortages page, hundreds of other drugs are in short supply. They include amoxicillin powder, cisplatin and clonazepam. Dr. Eleonora Teplinsky, an oncologist and social media influencer, described the impact that chemotherapy shortages have on patients. She cited cisplatin, a chemotherapy drug that treats testicular, ovarian, bladder and other types of cancer, as one example. “Imagine if you or a friend or family member was going through cancer treatment, and could not get the best possible chemotherapy that they needed or you needed,” Teplinsky said in the video. “Imagine if you were also told, ‘Well we can give you one dose, but we can’t guarantee a second or a third or a fourth dose.’ Imagine the fear and the anxiety and the nerves all of that would cause.” Teplinsky urged viewers to reach out to their elected officials: “Let’s make a difference,” she said. “Let’s all do it together.”

@drteplinsky #weneedchemodrugs #chemo #chemotherapy #oncologist #cancersurvivor #cancerdoctor ♬ original sound – Eleonora Teplinsky, MD

Of course, popular weight loss drugs such as Ozempic and Wegovy are experiencing shortages due to high demand. In 2023, the FDA issued a warning about unauthorized versions of the GLP-1 drugs beginning to circulate amid the shortages. Novo Nordisk, which manufactures Ozempic and Wegovy, plans to boost production in 2024. The company recently bought three of Catalent’s fill-finish sites that will be dedicated to boosting supply of the GLP-1 drugs. But in the meantime, people are waiting weeks and even months to get their weight loss prescriptions filled. Others are able to start the drugs but have to abruptly stop when their pharmacy runs out.

@holisticgynecology #MemeCut #Meme Wegovy backorder! Wegovy drug shortage 😩 #wegovybackorder #wegovyshortage2023 #wegovyshortage #lifeontiktok ♬ original sound – holisticgynecology

@bourbonrx If these pharma companies could get it together… that woukd be great #GLP1 #wegovyshortage #semaglutide #ozempicshortage #mounjaroshortage ♬ kardashianicon krisjenner – user64444993513

@branneisha So far what I’ve heard 7.5-12.5 MJ & 2.5-7.5 Zepbound is hard to locate. All strengths of Wegovy (except 2.4) too #zepbound #glp1 #shortages ♬ original sound – callum🫠

TikToker Jenna, who goes by @weightdoc on the platform, noted in one video that people often have to call 15 to 20 different pharmacies each month in order to locate an available dose of their weight loss drug. “That’s a lot of work, and not everybody has time and wants to call 15 to 20 pharmacies,” she said in the video.

@weightdocWhat to do about the wegovy shortage 😮 ♬ original sound – Dr Jennah | WeightDoc

@rosies.journeyy grwm while we chat about what happened after stopping semaglutide injections! #pcosweightlossjourney #wegovyweightloss #wegovy #wegovyshortage #semaglutide #semaglutideforweightloss #stoppingwegovy #semaglutidepcos #mounjarojourney #mounjaromonth1 #mounjaropcos #grwm ♬ original sound – rosie

Other TikTokers posted detailed videos on how to get GLP-1 drugs during a shortage. Many of the tips involve driving to faraway locations and calling every available pharmacy, from mom-and-pop shops to giant retailers.

@dinosaurmonkeyfarts Top 5 tips on how to find Wegovy or Mounjaro during a shortage. #glp1 #pcos #shortage ♬ original sound – DinosaurMonkeyFarts

Just this week, House Oversight Democrats sent letters to Big Pharma companies calling on them to address the shortages. Led by Rep. Jamie Raskin (D-MD), the Democrats sent letters to Pfizer, Sandoz and Teva Pharmaceuticals asking for a briefing on the issue — as well as a concrete plan to solve it — by March 6. “The current oncology drug shortage affects the clinical decision-making process, patient outcomes and quality of life, and without crucial oncology drugs, cancer patients face severe gaps in their treatment and an increased risk of severe, life-threatening complications,” the letter to Pfizer stated. In addition, the Federal Trade Commission recently announced it would be opening an inquiry into shortages plaguing generic drugs, as well as scrutinizing the practices of “middlemen” in the manufacturing supply chain.

The FTC and HHS added that the joint RFI aims to evaluate the impact of both entities on the overall generic medicines market by how they influence pricing the availability of drugs.

by Jack O’Brien The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) announced Wednesday that they would probe group purchasing organizations (GPO) and drug wholesalers for contributing to the nation’s ongoing generic drug shortages. The two federal agencies issued a Request for Information (RFI), seeking public comments regarding the market concentration of GPOs and drug wholesalers as well as their contracting practices. The FTC and HHS added that the joint RFI aims to evaluate the impact of both entities on the overall generic medicines market by how they influence pricing the availability of drugs. The general public will have 60 days to submit comments, documents and data at Regulations.gov, where they will be posted. In function, GPOs negotiate with drugmakers on behalf of healthcare providers for generic drugs and other medical supplies. Drug wholesalers, meanwhile, are companies that purchase drugs directly from manufacturers and deliver them to provider clients. Both GPOs and drug wholesalers are lucrative industries and, in the case of the latter, largely consolidated.  The three largest drug wholesalers — Cencora (formerly AmerisourceBergen), Cardinal Health and McKesson Corporation — account for more than 90% of wholesale drug distribution in the U.S., according to a study by the Commonwealth Fund.  Additionally, the healthcare GPO service market is a growing one that is projected to top $1.8 billion in 2029, according to data published by Valuates Reports at the end of last year, well exceeding its market size of $911 million in 2022. The report indicated this significant increase would be due to the increasing demand for cost-effective healthcare solutions.  The FTC has already been looking into a handful of GPOs as part of a separate investigation into the behavior of pharmacy benefit managers (PBM), including Emisar Pharma Services, Zinc Health Services and Ascent Health Services. “For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” FTC Chair Lina Khan said in a statement. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen. We look forward to public input as we assess how enforcers and policymakers can best address chronic drug shortages and promote a resilient drug supply chain.” HHS Secretary Xavier Becerra said the “devastating reality” of prescription drug shortages adversely impacting patient care is one that the federal government is seeking to curtail with this investigation.  “Today’s announcement is part of the Biden-Harris Administration’s work to tackle health care monopolies and lessen the impact on vulnerable patients who bear the brunt of this lack of competition,” he stated. “Today’s initiative is just one more action by HHS to best address shortages of generic drugs.” 

The FDA has listed 10, 12.5 and 15 mg doses of Eli Lilly’s popular diabetes drug Mounjaro on its drug shortages list.

by Lecia Bushak As GLP-1 drugs continue to face widespread shortages amid unprecedented demand, the Food and Drug Administration recently listed several higher doses of Mounjaro as being in limited supply. The FDA’s drug shortage website has identified 10, 12.5 and 15 mg doses of Eli Lilly’s diabetes drug Mounjaro as being in short supply through March. Lower doses of the drug, however, remain available. That’s a change from last month, during which only the 12.5 mg dose of Mounjaro was in shortage. Lilly told Reuters this week that it is working on boosting production of Mounjaro.  “We recognize this situation may cause a disruption in people’s treatment regimens and we are moving with urgency to address it,” the pharma giant said. In what is a common narrative around the rise of GLP-1s, Lilly as well as Novo Nordisk have experienced a supply chain squeeze when it comes to their popular weight loss drugs.  Novo has experienced Wegovy shortages since 2022, and in January 2023 decided to pull back on marketing efforts until those shortages were addressed. To help fill in those supply gaps, Novo Holdings — Novo Nordisk’s parent company — said it was acquiring drug manufacturer Catalent in a $16.5 billion deal announced this week.  Novo Holdings said it plans to sell three of Catalent’s fill-finish sites to Novo Nordisk in order to boost production of Wegovy and help the pharma company reach “more people living with diabetes and obesity with current and future treatments,” it said in a press release. However, Lilly expressed concern about the acquisition shortly after it was announced, as Lilly relies on Catalent to produce some of its own products. “Catalent is an integral part of manufacturing commercial and pipeline products for the industry, especially in diabetes and obesity, and we have products with these sites as well,” Lilly chief financial officer Anat Ashkenazi told analysts.. “Our focus today is on ensuring continuity of supply of medicine for patients is uninterrupted… [and] we intend on holding Catalent accountable to their contracts with us.” Lilly CEO David Ricks even called on antitrust regulators to scrutinize the acquisition, telling the Financial Times that “given the nature of this transaction — a vertical integration where the client list of Catalent might number in excess of 100 entities, all of which plan to compete in some way with Novo Nordisk — it sets up for an interesting inquiry by everybody [including] politicians.” Even as Lilly struggles to meet demand for Mounjaro, its other newly approved GLP-1 drug Zepbound has helped boost its bottom line.  The pharma released its quarterly report Tuesday, noting that its quarterly revenues rose 28% year-over-year, with Mounjaro and Zepbound largely contributing to that growth.

The Mapping America’s Pharmaceutical Supply (MAPS) Act would create a database that identifies supply chain weaknesses before they turn into a drug shortage.

by Lecia Bushak Drug shortages across cancer, attention-deficit hyperactivity disorder (ADHD), diabetes and other therapeutics have remained a persistent problem in the U.S. — and despite congressional setbacks, some lawmakers are trying to push legislation through to address it. Earlier this month, Rep. Larry Bucshon, (R-IN), and Rep. Doris Matsui, (D-CA), introduced a bipartisan bill that would help the federal government prepare for future drug shortages by creating a database mapping the pharmaceutical supply chain. The bill — called the Mapping America’s Pharmaceutical Supply (MAPS) Act — would design a database that tracks a drug product’s country of origin, the quantity manufactured and other information to pinpoint supply chain weaknesses before they snowball into a shortage. The goal is for the Department of Health and Human Services (HHS) to use the map to predict future supply disruptions. “Recent drug shortages across the nation have made it acutely clear that we need to improve our ability to anticipate, identify and respond to cracks in the system,” Matsui said in a statement.  She added that the lack of end-to-end visibility into every step of the nation’s pharmaceutical supply chain contributes to issues around reliance on other countries for key drug ingredients or how unexpected disruptions would impact the drug supply.  “The MAPS Act allows the U.S. to take control of our pharmaceutical supply chain, while recognizing the importance of collaboration between the government and private sector,” Bucshon added in a statement. While the U.S. has always faced drug shortages from time to time, the list of active ones reached its highest level in a decade last year, with more than 300 drugs being reported as in low supply. The American Society of Health-System Pharmacists, which monitors drug shortages, found in a survey conducted last year that one in three hospitals reported skipping or delaying prescriptions to patients due to supply issues. The survey also found that 57% of hospital pharmacists said they faced critical shortages of chemotherapy drugs, and this was having a negative impact on patients. Many of the recent drug shortages have dragged on over time without getting resolved, according to a recent IQVIA report. Among the 132 active shortages listed in the IQVIA report, 75% were active for over a year, with 58% active for more than two years. Congress returns to tackle drug shortages In the last year, lawmakers in Congress have sought to pass several pieces of legislation that aim to address the lingering problem.  However, gridlock between Republicans and Democrats left several bills in the air, with Republicans blocking a Democratic effort to include a drug shortage provision in the Pandemic and All Hazards Preparedness Act. During this past summer, GOP leaders unveiled a draft of another bill, the Stop Drug Shortages Act, which aimed to boost transparency among pharmacy benefit managers and require the Food and Drug Administration to report active pharmaceutical ingredient metrics for generic drugs. Since then, however, a back-and-forth between Republicans and Democrats in Congress left several drug shortage bills in limbo, with both sides seeking to block each other’s efforts. “Unfortunately, many of the proposals in the Republican discussion draft may actually lead to more drug shortages and increased profits for the pharmaceutical industry, while raising costs for consumers,” Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) said during a September 2023 hearing on the drug shortage crisis.  Meanwhile, the American Hospital Association voiced its support of the MAPS Act, most recently noting that it was an important bipartisan legislation that will strengthen the pharmaceutical supply chain for healthcare providers and patients and improve access to high-quality care. The drug shortage issue also recently spurred the FDA to announce it would allow the U.S. to import a syphilis drug, extencilline, from French pharma company Laboratoires Delbert — amid a limited supply of Pfizer’s Bicillin L-A.

The FDA took a step to address the shortage of syphilis drugs as Pfizer’s main treatment, Bicillin L-A, remains in limited supply – all while syphilis cases continue to rise.

by Lecia Bushak As the U.S. continues to face a series of drug shortages – from cancer drugs to obesity drugs – the Food and Drug Administration is turning to a French pharma company to help ease the dearth of Pfizer’s syphilis drug, Bicillin L-A. In recent days, the FDA announced it would temporarily allow the U.S. to import a different syphilis drug manufactured by Paris-based Laboratoires Delbert, known as extencilline, amid rising syphilis cases. In an announcement, the FDA noted that extencilline “has been determined to be equivalent to Bicillin L-A and is currently authorized and marketed in other countries.” The agency said extencilline will only be available by prescription and noted that it is working with partners to resolve the “programmatic implications” of this announcement, adding that it will provide updates. Laboratoires Delbert said it would import 1.2 million units of powdered extencilline, along with 2.4 million units of its injectable version. Pfizer first pointed out shortages of Bicillin L-A, which treats syphilis and other bacterial infections, last year. It said its dwindling supply of the drug was caused by a combination of factors, including increased demand amid a spike in syphilis infection rates, exacerbated by competitive shortages. Syphilis is a bacterial infection that is often spread through sexual contact, and appears as sores on the genitals or mouth. Syphilis cases have been on the rise in the U.S. in the last few years, with cases rising 74% between 2017 and 2021, according to the Centers for Disease Control and Prevention. In addition, cases of congenital syphilis have risen more than 203% in that same period. Some public health experts have pointed to the disruption of STI prevention services during the COVID-19 pandemic as being part of the reason behind the rising cases. However, other researchers have sought to establish a potential link between changes in sexual practice in the last decade, such as unprotected casual sex and the rising use of dating apps. Shortages of Bicillin L-A led 39 health organizations, including the Association of Maternal and Child Health Programs and AIDS United, to write a letter to the White House’s Drug Shortage Task Force in October 2023 urging the team to prioritize making more of the antibiotic available. “As the only manufacturer of penicillin G benzathine in the U.S., Pfizer’s inability to provide adequate quantities of Bicillin L-A has left the FDA, the CDC, and many local and state health departments scrambling to ration existing supply of the drug and develop contigency plans,” the letter said. Bicillin L-A isn’t the only drug in short supply in the U.S. Attention-deficit hyperactivity disorder, cancer and diabetes drugs have all faced record levels of shortages in the last year, and pharmacists and healthcare providers are reporting a negative impact on patient care. A survey released by the American Society of Health System Pharmacists last year found that one in three hospitals reported skipping, delaying or reducing the amount of medication to patients due to shortages. Nearly all hospital pharmacists said they were experiencing shortages, leading them to ration drugs.

The report found that low-cost drugs, particularly generics, are more likely to face shortages than high-cost drugs.

by Lecia Bushak Drug shortages in the U.S. — exacerbated by the COVID-19 pandemic — remain a stubborn problem, especially for a select group of medications. Attention-deficit hyperactivity disorder (ADHD), cancer and diabetes drugs were all impacted by record levels of shortages in 2023, with pharmacists and healthcare providers reporting a negative impact on patient care. A recent report out of IQVIA this week sheds light on some of the aspects of the issue — and points to the shakiness of the generics industry, which is more likely to face shortages than high-cost drugs. The report includes shortages listed by the Food and Drug Administration, noting that the U.S. faced shortages among 132 molecules. Over the last five years, an average of 25 new molecule shortages hit per year. They also tend to drag on over time without getting resolved. Of the 132 active shortages listed in the report, 75% were active for over a year, while 58% were active for over two years. Additionally, the report found that shortages are more likely to occur in drugs with low list prices, with low-cost drugs accounting for 56% of the 125 drugs in shortage. Eleven percent of all drugs costing less than $1 per extended unit faced shortages, compared to 1.3% of drugs priced at $500 or more per unit. “Shortages disproportionately affect generics,” explained Craig Burton, SVP of policy and strategic alliances at the Association for Accessible Medicines, in an IQVIA Institute video breaking down the report. “For companies doing business in the generic space… the report points to the rising challenge of overall sustainability of generic manufacturing and some of the challenges facing the industry as a whole.” Burton added: “There is a very real danger that the low-cost generics we take for granted may not always be there.” Oncology drugs have been particularly hit hard with shortages since 2020, with four drugs – cisplatin, methotrexate, capecitabine and carboplatin – facing shortages between March and June of last year. However, other therapeutics have been impacted by shortages as well, with pediatric oral liquid antibacterials, injectable antibacterials and anesthetic shortages included in the report. Psychiatric medications have also faced shortages, spurred by what the authors of the report believe is increased awareness of mental health issues and greater access to mental health care via telehealth. ADHD drugs, in particular, have been in stark shortage. Finally, GLP-1 drugs that treat diabetes and obesity have faced significant shortages since hitting the market in recent years, with use of the drugs doubling since 2020. There are a variety of factors behind drug shortages, including manufacturing quality problems, supply issues and backlogs in regulatory inspections. “Many shortages last more than a year, which speaks to the … [need] to deal with shortages [by preventing] them on the front-end,” explained Burton. “Once a product is in shortage, it’s not easily solved. There may be a long ramp-up time, there’s certainly marketing uncertainties, there’s pricing dynamics… All of which can discourage entry of other manufacturers that might alleviate the shortage.”

It’s a new year but a lingering problem around opioids in America remains. However, it may not be the one most people are thinking about. On December 28, 2023, the Drug Enforcement Administration issued a pre-published notice that it would continue on with its plan to reduce the supply of codeine, morphine, oxycodone and other opioids this year. On Wednesday, the final production quotas were published in the Federal Register.   The decision came nearly two months after a notice listing the proposed APQs was published in the Federal Register and opened to public comment until December 4.  The agency received nearly 4,700 comments from a host of stakeholders, both foreign and domestic, who argued that there were issues with medication out of stock at the pharmacy level, nationwide shortages as well as instances of patients switching to fentanyl or other medications obtained from illegal sources. Ultimately, the DEA said that after considering all of the relevant factors, it determined that the aggregate production quotas (APQ) of prescription opioids should be reduced from 2023 levels and “are sufficient to meet the forecasted domestic and foreign medical needs.”

According to two opinion pieces published in The Hill this week, there’s no simple answer to the nation’s ongoing drug shortages. It’s no secret that the nation is enduring a severe, complicated drug shortage – but what can be done about it. According to two opinion pieces published in The Hill this week, there’s no simple answer. On Monday, Randall Lutter, a senior fellow at the Manhattan Institute, a conservative think tank, called on Congress to demand the Food and Drug Administration do more to explain itself, mitigate shortages and increase supplies of approved medicines. Lutter charged that the FDA’s publicly released data does not fully encapsulate the severity of the drug shortages nor does it explore the persistence of the problem.  He wrote that Congress’ passage of the CARES Act in 2020, which gave the FDA greater power to collect information from drugmakers on potential shortages has not been effective, with a 22% rise in unresolved pharmaceutical shortages from February 2022 to September 2023. In order to fix this issue, Lutter said Congress should require an independent assessment of four components of the FDA’s response plan. “First, it needs to ascertain the timeliness of FDA’s listing and delisting of drugs and biologics in shortage,” he wrote. “Second, Congress ought to measure the effectiveness of FDA’s response to short-term shortages versus persistent ones. Third, it should quantify the success of FDA’s response to especially severe shortages. And lastly, Congress needs information on the effectiveness of select shortage-mitigation measures, such as importation of foreign drugs.” He added that Congress should also take steps to formalize and promote the agency’s efforts to encourage drugmakers of similar drugs approved and marketed abroad to export them to the U.S. Meanwhile, Raymond J. March, a research fellow and director of FDAReview.org at the Independent Institute and an assistant professor of economics at North Dakota State University, criticized political promises from both sides of the aisle and the White House that have not remedied the drug shortages dilemma. March wrote that the “clear culprit” preventing an increase in the domestic drug supply is regulation and said federal efforts to fix the problem are unlikely to help due to what he deemed to be excessive red tape. By easing drug import policies, similar to how the U.S. relaxed its stance on manufacturing and transportation requirements of Chinese medical goods at the start of the COVID-19 pandemic in early 2020, March asserted that the supply of medicines in this country could be replenished. “Drug shortages are a serious and sometimes deadly threat. While disruptions in the supply chain exacerbate this problem, they merely indicate a more systemic issue: the stringent regulatory environment that hinders the supply of essential medications in the U.S.,” he wrote.

In addition to the ongoing drug shortages in America, the European Union listed hundreds of critical medicines this week in a bid to prevent shortages. The Food and Drug Administration stated Tuesday that Sodium Chloride 14.6% Injection and Sodium Chloride 23.4% Injection are currently in shortage. The American Society of Health-System Pharmacists (ASHP) also maintains a running list of current drug shortages and sorts them by name of the drug, bulletin revision date and bulletin creation date. Below are drugs that the ASHP revised the bulletin for during the past week: • Mitomycin Injection • Bupivacaine Injection • Potassium Chloride Injection • Potassium Phosphate Injection • Nirsevimab-alip Intramuscular Injection (Beyfortus) • Vitamin A Injection • Desmopressin Acetate Nasal Spray • Carboplatin Solution for Injection • Cefdinir Oral Presentations • Cisplatin Injection • Fentanyl Citrate Injection • Fluorouracil Injection • Glucagon Injection • Heparin Sodium Premixed Bags • Hydroxyethyl Starch • Lidocaine with Epinephrine Injection • Midostaurin Capsules • Leucovorin Calcium Injection • Acetylcysteine Oral and Inhalation Solution • Adenosine Injection • Alfuzosin Extended-Release Tablets • Amifostine Injection • Aminophylline Injection • Atropine Sulfate Injection • Betaxolol Tablets • Bumetanide Injection • Busulfan Injection In addition to the ongoing drug shortages in America, the European Union listed hundreds of critical medicines this week in a bid to prevent shortages. Australia also warned of a scarcity of critical medicines following a year marred by widespread drug shortages.

However, experts have expressed skepticism that using the Defense Production Act will result in the fixes to the national drug shortages that the White House is aiming for. The nation’s ongoing drug shortages is a top health policy priority for the White House, which has explored an unconventional approach to fixing the issue. At the end of last month, President Biden announced that he would leverage the Defense Production Act to boost domestic production of prescription drugs and essential medicines. The Defense Production Act allows the president to order private manufacturers to expedite and expand the production of materials and services used to promote national defense. Many may recall when Former President Trump utilized the law to respond to the start of the COVID-19 pandemic in March 2020. Ultimately, the Biden administration is slated to spend $35 million to boost production of drugs that are commonly in shortage for hospitals and health systems. Of note, these 15 cancer drugs only account for just over 10% of the drugs included in the Food and Drug Administration’s shortage list. However, despite using the levers at the president’s disposal, experts have expressed skepticism that using the Defense Production Act will result in the fixes to the national drug shortages that the White House is aiming for. An administration official told STAT News earlier this week that this plan to boost production won’t expand the supply of the chemotherapies that are currently in shortage. This action by the administration comes after years of severe supply chain challenges that were disrupted in part by the pandemic as well as other contributing factors. This is yet another example of the Biden administration taking aim at vulnerabilities in the current drug production system. Two years ago, the White House issued an executive order to establish a private-public consortium to boost domestic production of these critical medicines. While Marta Wosińska, senior fellow at the Brookings Institution’s Schaeffer Initiative on Health Policy, told Axios that the administration’s latest directive is “quite positive,” there has been a clamoring among some public health experts for additional actions. “I’d like to see along the full manufacturing process more quality investment, because we know quality is one of the major issues behind drug shortages, whether domestic or overseas,” Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, told Axios.