Sunday, February 27, 2005

Impact of financial remuneration on FDA Advisory Committee voting

I'm not sure how the PDUFA's provisions for mandatory fees paid by drug companies to the FDA constitute a conflict of interest as suggested by GW in a comment. These fees are required to get their drugs into the FDA approval process whether the drug is approved or not.

However, for an FDA advisory committee member evaluating the COX-2 inhibitors, affiliation with Pfizer or Merck appears to constitute a clear conflict of interest. Consider these numbers I extracted from the vote breakdown in one report. If you were one of 10 committee members taking money from Pfizer or Merck,

  • You had a 100% probability of supporting Bextra compared with a 35% if you had no such tie.
  • You had a 90% probability of supporting Vioxx compared to 36% if you had no such tie.
  • If these 10 committee members had abstained from the vote, neither drug would have been approved for marketing.
To suggest that this breakdown occurred by mere chance and had nothing to do with drug company affiliation strains credulity to say the least!

(Celebrex was approved 31 to 1 so the votes of those 10 would have made no difference.)

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3 Comments:

Blogger Henry Stern, LUTCF said...

While I'm not usually one for conspiracy theories, this strikes me as an egregious abuse of regulatory power.

I am disappointed that this story hasn't received more play in the MSM. If you have no objections, I'd like to cross-post this on my blog, in the hopes that at least some others will see it.

Thank you for doing this research!

February 28, 2005 8:10 AM  
Blogger Gina W said...

Well, yes, the fees are mandatory (waived in some cases though), but the idea behind the fees is that they are to be used to help speed the approval process. When the fee is paid, then the clock starts ticking, and the FDA has an obligation to the sponsor to meet certain goals under strict deadlines. Not only that, but the fees are, in large part, used to hire and maintain employees who review the drugs.

Furthermore, there is no obligation on the part of the sponsor to introduce a drug that is safer and more effective than drugs that are already on the market - the drug need only be deemed safe and effective. No wonder there is a seemingly endless stampede to get the me-too drugs out there and market the heck out of them. Does this approach best serve the consumer? How many ED drugs does the world really need?

March 01, 2005 10:22 AM  
Blogger Gina W said...

If the user fees constitute roughly half of the budget of the drug evaluation arm of the FDA (which they have in the past); and there is pressure on the FDA to conduct the review quickly; and the reviewers’ salaries and benefits are paid via the user fees; and the same groups (including advisors with direct ties to the pharmaceutical industry - the COX-2 example is not unusual) who approve the drug decide, when problems arise, whether a drug should remain on the market or labeling changes should be made; I see a clear conflict of interest.

Shouldn’t there be a more impartial review process with an emphasis on safety not speed? If the pharmaceutical companies and the FDA want to bring new drugs to market faster, especially the me-too variety, shouldn’t there be an excellent system in place to track ADRs then?

Other important questions arise about the advantages big drug companies have over small ones at the FDA and the effect of the system on the development of drugs for orphan diseases.

March 01, 2005 10:24 AM  

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