Washington Insider

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

FTC sees gain in high court pay-for-delay rule

FTC sees gain in high court pay-for-delay rule

The Federal Trade Commission (FTC) says that a June Supreme Court decision finding so-called pay-for-delay patent dispute settlements not inherently anticompetitive has put the agency in a stronger position to protect consumers from such settlements

Study links DTC ads, statin overuse

A study of prescription drug direct-to-consumer advertising suggests that it may promote over-diagnosis of high cholesterol and over-treatment for populations where risks of statin use may outweigh potential benefits.

As I See It: Dealing with the Surveillance State

As I See It: Dealing with the Surveillance State

Just like the NSA can monitor national security, FDA market-watchers can track what pharma marketers are doing.

FDA revising promotion guidances, says Abrams

FDA revising promotion guidances, says Abrams

The FDA is reviewing two drug-promotion guidances, according to CDER Office of Drug Promotion director Tom Abrams

Ruling shields scientific opinions

The Second Circuit Court of Appeals affirmed a New York federal court ruling that scientific opinions in a journal article could not give rise to claims of false advertising

As I See It: The battle for better compliance

As I See It: The battle for better compliance

While there are successes in the battle for better adherence/compliance, we're losing the war

FDA: Industry clamoring for breakthrough status

FDA: Industry clamoring for breakthrough status

FDA director of drug evaluation and research Janet Woodcock says she is amazed that FDA has had more than 30 requests for its new breakthrough therapy designations and it has granted 11 already.

As I See It: Activism and the FDA

As I See It: Activism and the FDA

Appendages of the HHS secretary's apron strings, FDA commissioners must toe the "party line"

FDA: Pradaxa fell prey to "stimulated reporting"

FDA: Pradaxa fell prey to "stimulated reporting"

FDA drug safety officials say that an influx of numerous bleeding reports associated with Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) is a case of "stimulated reporting"

New approval paths needed: report

Organization including the Pew Charitable Trusts are voicing basic suppor for FDA's efforts to develop an alternative approval pathway for certain drugs

As I See It: the Sunshine Act

As I See It: the Sunshine Act

People in the industry must be worried about the type of care doctors are now giving

Drug quality is FDA's top 2013 priority: Hamburg

Drug quality is FDA's top 2013 priority: Hamburg

FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality

"Conditional approval" draws dissent

The idea of scaling back premarket clinical trials comes under fire

As I See It: Life under the "Sunshine Act"

As I See It: Life under the "Sunshine Act"

While we all like the sun, life under the final rules for the "Sunshine Act" provisions of the Affordable Care Act is going to be complicated and treacherous for drug companies and their agencies.

FDA mulls fast approval for unmet-needs drugs

FDA mulls fast approval for unmet-needs drugs

FDA is exploring an alternative drug-approval pathway for drugs intended to address unmet medical needs by "limited use" approvals.

Innovator risks over generic warnings

The Alabama Supreme Court ruled that a man who claims he was injured by a generic version of Pfizer's Reglan can sue the innovator company.

As I See It: FDA and the First Amendment

As I See It: FDA and the First Amendment

FDA has never won a First Amendment case, and its string of losses led it to bring this one under false colors


Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.

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