Beltway Insider

Clinton or Trump? Either Way, Change Is Coming

Clinton or Trump? Either Way, Change Is Coming

Donald Trump and Hillary Clinton offer clear contrasts on the issues of the Affordable Care Act, entitlement reform, and drug pricing.

Reframing the Debate: Why Drug Spending Can Lower Costs

Reframing the Debate: Why Drug Spending Can Lower Costs

Rising healthcare costs, coupled with high-profile stories of price gouging at some small pharmaceutical companies, have left consumers feeling ripped off

The FDA's Actions Open Door to 'Truthful, Non-Misleading' Marketing

The FDA's Actions Open Door to 'Truthful, Non-Misleading' Marketing

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That change is coming about in the wake of a string of First Amendment-based losses for the FDA in federal courts around the country.

Finding a Better Strategy for Pricing Drugs

Finding a Better Strategy for Pricing Drugs

We need to consider that not every expenditure is beneficial to patients: perhaps that Super Bowl commercial or that sales meeting in Maui may not be in their best interest.

Speeding up FDA Approvals Calls for Pause

Speeding up FDA Approvals Calls for Pause

The idea that 30 days is enough time for the FDA to evaluate anything is, of course, quite silly. But Sen. Cruz takes it one step further.

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

An Election Year Puts Pharma In The Spotlight

An Election Year Puts Pharma In The Spotlight

In a town where the main business is politics, the election of a new president heightens the intensity.

What Happens Now with Off-Label Communications?

What Happens Now with Off-Label Communications?

Anyone who thinks that the argument over off-label communications is just about marketing and sales is looking at the issue through very narrow blinders

Washington Insider: Patient Power and Social Media

Washington Insider: Patient Power and Social Media

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Would you expect that patient power exerted through social media might shake the job of a high-level FDA center director?

Washington Insider: Drug-Safety Legislation

Washington Insider: Drug-Safety Legislation

When will the pharma industry resume working with Congress on drug safety?

Washington Insider: 21st Century Cures

Washington Insider: 21st Century Cures

Passing the 21st Century Cures Act was a bipartisan success due to open lines of dialogue among stakeholders

Washington Insider: Good-bye, Commissioner Hamburg

Washington Insider: Good-bye, Commissioner Hamburg

Perhaps the best testament to Commissioner Hamburg's tenure is that crises were uniformly handled responsibly

Washington Insider: Paul Thacker

Washington Insider: Paul Thacker

After a decade spent stalling, denying and attacking critics, the University of Minnesota has finally admitted some complicity in the death of a patient during a clinical drug trial.

Washington Insider: James G. Dickinson

Washington Insider: James G. Dickinson

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The FDA has to respect First Amendment limitations regulating scientific communication

Washington Insider: John Kamp

Washington Insider: John Kamp

The FDA must address its policies to accommodate the new medical and media environment

Washington Insider: POC Communications

Washington Insider: POC Communications

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With POC on the march, the FDA will have to stretch its monitoring efforts to keep up

Washington Insider

Washington Insider

One issue lurking for marketers is the potential elimination of the tax exemption for advertising

Washington Insider - Dec 2014

Washington Insider - Dec 2014

I come not to bury government but to praise it—at least the singular agency I know best: FDA

Washington Insider: Mistruths and half-truths about oncology meds

Washington Insider: Mistruths and half-truths about oncology meds

Demonizing new treatments distracts from the real problem: policies that focus on the near-term

Washington Insider : Science, Not Ideology

Washington Insider : Science, Not Ideology

A charge of sexism against the FDA clouds the views surrounding a drug's application

Washington Insider: Open Payments

Washington Insider: Open Payments

Problems and changes have set ablaze criticism over the Sunshine Act's implementation

Washington Insider: When FDA Overstates its Case

Washington Insider: When FDA Overstates its Case

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What happens when it's the FDA—not a medical marketer—that is doing the overstating?

As I See It: Patient Centricity

As I See It: Patient Centricity

A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive

Let FDA top performers set pace, study says

Let FDA top performers set pace, study says

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A Manhattan Institute analysis says that helping underperforming FDA drug review divisions match the output of high-performing divisions could cut development costs and speed approval of new treatments.

Did lawyers help write labeling rules?

Did lawyers help write labeling rules?

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Nineteen Republicans on the House Energy and Commerce Committee want FDA commissioner Margaret Hamburg to explain the role the American Association for Justice (trial lawyers) played in drafting proposed changes to generic drug labeling.

As I See It: FDA's social-media moves

As I See It: FDA's social-media moves

FDA has insisted that its antique regulations can address every new promotional challenge

It's time to replace the FDA, says Newt Gingrich

It's time to replace the FDA, says Newt Gingrich

Former Speaker of the House and presidential candidate Newt Gingrich has declared that it's time to replace FDA

As I See It: FDA and marketing materials

As I See It: FDA and marketing materials

The more clarity that FDA provides, the more confident companies can be in their medical communications

Did "pay-to-play" confab help Zohydro approval?

Did "pay-to-play" confab help Zohydro approval?

US senators Joe Manchin (D-WV) and David Vitter (R-LA) are asking whether a "pay-to-play" meeting between drug industry executives and FDA officials influenced the agency's approval of Zohydro

Broadcast DTC risk info could shrink

FDA's Office of Prescription Drug Promotion (OPDP) plans to research the effects that could follow changing the risk information the agency requires to be included in such direct-to-consumer ads.

As I See It: Access to data

As I See It: Access to data

We need for pharmaceutical companies to come forward and make the pledge to stop hiding data

Waxman, a tough critic of industry, is retiring

Waxman, a tough critic of industry, is retiring

California Democrat Henry Waxman, one of the strongest FDA overseers and drug industry critics on Capitol Hill, will step down when the House of Representatives adjourns for the mid-term elections

Breakthrough requests swamp FDA

Breakthrough requests swamp FDA

FDA's drug center says it has been so overwhelmed with industry's response to its new Breakthrough Therapy program that it is becoming difficult to promise an "all hands" commitment.

As I See It: FDA and the First Amendment

As I See It: FDA and the First Amendment

FDA's Warning Letter to Aegerion is a bureaucratic thumb in the eye to the US Court of Appeals

Supreme Court declines drug free-speech case

Supreme Court declines drug free-speech case

The US Supreme Court has declined, without comment, to hear a closely watched appeal by former InterMune CEO Scott Harkonen on whether someone can be prosecuted for speaking truthfully about a drug.

FDA stand on compounding criticized

Public Citizen has written FDA asking it to stop making "misleading" statements about pharmacy compounding

As I See It: Small is the new Big

As I See It: Small is the new Big

It's fast becoming an n of 1 world, where every disease is an orphan disease and success is measured by individual outcomes

FDA and advisory panels mostly on the same page

FDA and advisory panels mostly on the same page

A McKinsey Center for Government analysis shows that in the period 2001-2010, FDA approved 88% of NDAs and BLAs that were supported by advisory committees and did not approve 86% of those not endorsed by the committees.

RTI to study DTC ad response for FDA

Under a $4-million contract from FDA, RTI International researchers will look at consumers' responses to risk, benefit and cost information in direct-to-consumer prescription drug ads

As I See It: Quality programs

As I See It: Quality programs

Keeping up with quality programs often feels like a safari in a jungle of government paperwork

AdCom chair bows out of meeting under fire

AdCom chair bows out of meeting under fire

Under pressure from Public Citizen and FDA, Dermatologic and Ophthalmic Drugs Advisory Committee chair Lynn Drake withdrew her acceptance of an invitation to provide a presentation to industry on winning a favorable panel endorsement.

Faster reviews increase risks: study

Two researchers say that expedited review of new drugs may have exposed some patients to safety risks that had not been well characterized.

As I See It: FDA reorganization

As I See It: FDA reorganization

Could PAG change the FDA inspection paradigm from honest, objective assessments to faster, easier ones?

Feds to take closer look at "native advertising"

Feds to take closer look at "native advertising"

The Federal Trade Commission has announced a Dec. 4 workshop to "examine the practice of blending advertisements with news, entertainment, and other content in digital media."

FDA cracking down on quality lapses

FDA's director of drugs, Janet Woodcock, said in September that she will personally direct the agency's latest push to advance pharmaceutical quality.

As I See It: Transparency and clinical trial data

As I See It: Transparency and clinical trial data

By opposing making clinical trial data public, Pharma is once again swimming against the current

Stakeholders anxious over FDA data policy

Stakeholders anxious over FDA data policy

FDA stakeholders in industry and academia told the agency in August that they're concerned about its newest initiative to make clinical trial data more publicly available

Industry ties may expand indications

A study of government drug review advisory panels suggests that those with members who have financial ties to the drug industry recommended expansion of labeled disease indications for the drugs examined

As I See It: The Sunshine Act's CME exclusion

As I See It: The Sunshine Act's CME exclusion

CMS recognized that the rules in place for CME provide for separation from supporter influence

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