Friday, September 21, 2007

FDA Compromise Bill Passes: Adding Up the Score

The House passed by a 405-7 vote on Wednesday, 9/19 a compromise measure to extend the FDA's Prescription Drug User Fee Act (PDUFA) by another 5 years. The Senate followed suit the next day and it was anticipated that the bill would quickly be signed by the President, in time to prevent the FDA from having to issue pink slips to 2000 employees as time runs out on the old PDUFA arrangement.

The compromise bill contains several important measures, and some provisions that remind us about the adage of not wanting to watch either sausage or legislation being made. Here's a quick run-down from my point of view:

Good News
  • The FDA has increased authority to require companies to do post-marketing safety studies, and impose fines on companies that do not comply. In the past, the vast majority of these requested safety studies were never completed, and the FDA had only the blunt instrument of withdrawing the drug from the market as a method of enforcement.
  • The FDA will for the first time have a computerized safety monitoring system utilizing insurance and pharmacy claims data. The existing system depends solely on voluntary reporting of side effects and drug reactions and is estimated to miss 90% of such events.
  • The House eliminated some Senate provisions that would have protected drug companies from liability suits. Under the compromise version it is harder for a drug company to argue in court that since the FDA approved the drug and its labeling, the company has no liability if the drug ends up killing people.
  • The FDA can actually force companies to alter labels rather than always having to ask nicely.
  • Companies are required to post results of all clinical trials of approved drugs on a public, searchable website.
  • The FDA gains some new powers to better police deceptive advertising.

Bad News
  • The basic PDUFA mechanism remains in place. The industry, not the U.S. public, provides the lion's share of the funds that the FDA uses for the drug approval and safety monitoring process. This perpetuates the basic flaw that FDA critics argue has been the result of PDUFA--that the FDA inevitably sees the industry as its client, rather than seeing its overriding duty as protecting the public health.
  • Conflict of interest waivers, allowing scientists with financial ties to the industry to participate in FDA advisory panels despite the rules that supposedly ban such participation, was a particular political football. The Senate version wanted no limits on waivers; the House wanted only one waiver per meeting. (I would vote for none.) The compromise result is delightfully Byzantine. The FDA should count how many waivers it granted in the 2007 fiscal year and reduce the number granted by 5% per year in each of the following 5 years. Congress--ya gotta love 'em.
  • The pediatric trials scam continues. For initially excellent motives, Congress agreed that if a company tested its drugs in kids, they would get a 6 month patent extension in exchange. It turned out in practice that the cost of the research in kids was substantially less than the profits made from the 6 month extension, leading to major abuses where drugs that would never be used in kids were tested in kids anyway just to get the extension. The Senate had reasonably wanted to reduce this extension to 3 months; but the compromise version keeps it at 6 months.
  • Stronger powers to regulate drug ads, especially a moratorium on direct-to-consumer ads for new drugs, were beaten down by intense lobbying by the media and advertising industries, which clearly don't want to see the DTC-ad cash cow dry up.
Harris G. House passes bill giving more power to the F.D.A. New York Times, Sept. 20, 2007.

Kaiser Daily Health Policy Report. House approves prescription drug user fee act reauthorization.

Wilde Mathews A, Kang S. Media industry helped drug firms fight ad restraints. Wall Street Journal, Sept. 21, 2007; page B1.

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