Drug shortages in America

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.

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.