Again, FDA Promotes Pharma's Interests

By D. Cupples   |  In a letter Friday, House Oversight Committee Chair Henry Waxman (D-CA) asked the U.S. Food and Drug Administration (FDA) to reconsider a move that could prove dangerous to the public. This is not the first time the FDA has seemed to prioritize drug companies' interests over public safety.

According to Center for Responsive Politics data, incidentally, the pharmaceutical/health products industry spent $108+ million on lobbying this year alone; during the 2000-2006 election cycles, the industry gave $67+ million to candidates for federal office.  In part, Rep. Waxman's letter states:

"I have obtained a copy of an October 2007 internal draft of new FDA guidance that
would allow drug companies to use journal articles to promote potentially dangerous uses of drugs and medical devices without prior FDA review and approval. It is my understanding that the FDA intends to issue this guidance without significant changes in the very near future. I urge you to refrain from going forward with this ill-advised guidance.

"A fundamental tenet of our drug and device laws is that a manufacturer cannot market a
drug or device for a therapeutic use without FDA approval. The draft guidance would carve a large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved (off-label) uses of their products without first obtaining FDA approval by passing out journal articles about the off-label use to physicians.

"Published reports of company funded studies can be biased in favor of the company's product. Allowing drug and device companies to freely disseminate these articles can result in doctors using questionable study results to guide their prescribing habits. In addition, allowing marketing through journal articles can reduce the incentive for drug and device companies to conduct the rigorous studies needed to win full FDA review and approval, leaving physicians and patients without definitive data on the benefits and risks of medical products." (See letter)

It's not exactly news that the FDA tends to protect drug-company interests.  In June, for example, we learned that an FDA scientist pushed for black-box warnings on the label of diabetes drug Avandia, because studies suggested that people taking Avandia faced 30% - 43% higher risks of heart attack. Black-box warnings aren't good for drug sales, because they tend to scare the public.

After complaints from FDA officials with ties to GlaxoSmithKline (Avandia's maker), the scientist "was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia." (BN-Politics) After investigating the scientist's claims, Senator Charles Grassley (R-Iowa) stepped in and chastised the FDA commissioner.

Fortunately, congressional oversight can work. The PharmaFraud blog has more information in FDA & Pharma issues.

Related BN-Politics Posts:

* FDA's Latest Pharma-Friendly Sins

* Pharma-Paid Doctors Wrote Risky Scrips for Kids

* FDA Criticized for Bureaucrats' Bonuses

* Why Are Drug Prices so High (GAO 7 Other Sources)?

* Did the FDA Endanger Diabetics?

* Pharma President is Un-named Ex-Official in Jefferson Indictment

* Contractor Fraud: Driving Up Healthcare Costs

Comments

[PharmaFraud]

Thank you for addressing this topic. Quite frankly, I attempted to cover this issue on my own blog, but as I stared at my blank screen I became convinced that I’d finally slipped into a full-blown psychotic episode. Only in a bizarre parallel universe, where up is down and sense is nonsensical, could one federal agency work to allow off-label marketing, while at the same time, another federal agency has numerous active lawsuits against Big Pharma for their engagement in the exact same practice.

And, of course, thanks for linking to my blog!

[On a Limb with Claudia]

Oh shock me. My hubby works in DSMB data management. You'd be surprised what goes on. The FDA has a long history of being scumbags.

[D. Cupples]

I agree about the long-history part. Part of the FDA's troubles seem to have started in 1992, with the passage of the Prescription Drug User Fee Act (not sure if I remember the name exactly), which directly tied FDA revenues to drug company dollars.