People like me tend to think badly of the FDA's recent track record. The FDA funding bill now in House-Senate conference committee perpetuates the system of allowing industry user fees to fund much of the drug review process, making the agency more beholden to the industry. The Senators who shepherded the bipartisan compromise bill through, Kennedy and Enzi, seem to have bought into the line of bunkum that if the FDA advisory committees were actually required to exclude those who had financial conflicts of interest, there would be no "experts" left to fill the committee slots.
Dr. Jerry Avorn of Harvard, author of Powerful Medicines and a well-known critic of the pharmaceutical industry and regulatory system, writes in this week's New England Journal that it is not as bad as all that. He reviews several recent decisions from FDA scientific advisory committees that show considerable backbone in standing up for drug safety and protecting the U.S. public. He compares the recent drug action to an action on a similar drug within the past decade, and shows that for the drugs Arcoxia (anti-inflammatory) and rimonabant (weight loss), the recent decision was much more scientifically defensible and hard-nosed than was the previous one. The one disappointment he admits to is Avandia, noting that its advantages as a drug for diabetes are so meager that it is hardly defensible to keep it on the market in light of fears of increased heart risks.
Avorn has basically given up on the FDA or Congress cleaning up its own messes and so calls on the scientists who serve on the external advisory committes to shoulder the burden of standing up for the facts. He reminds us that when we compare the regulation of the drug industry with the energy, defense and finance sectors, we have it head and shoulders above them in our ability to bring rationality and science to bear on the problems, even with our present flawed system.
Avorn J. Keeping science on top in drug evaluation [perspective]. New England Journal of Medicine 357:633-35, Aug. 16, 2007.