Finally FDA Gets a Modicum of Common Sense

Feeling heat from Congress and the public, the FDA finally took a step in the right direction in terms of drug safety yesterday, announcing new rules that will bar some experts receiving money from pharmaceutical companies and makers of medical devices from serving on advisory committees voting on those same company's products.

A medical expert receiving more than $50,000 from a company whose product is being evaluated or a competitor would be banned from serving on FDA committees. Those making less than that could join a committee and participate in discussions about products, however, which means bad decisions remain likely.

The straw that broke the proverbial camel's back: Reports that massive conflicts of interest were involved in an advisory committee's voting on Vioxx, Bextra and Celebrex more than two years ago.

So far, the only known loophole in these tougher rules: Waivers in the selection process of experts advisers are possible, but only the FDA commissioner can approve them, and the agency claims those exceptions will be rare. Still, some Congressmen still remain concerned about hidden loopholes that could completely circumvent these tougher rules. In the meantime, the major marketing arm of drug companies, the Pharmaceutical Research and Manufacturers of America, is laying low... for now.

All that said, this long overdue news shouldn't lower your guard one tiny bit when it comes to trusting the purported safety of a drug. Yesterday's announcement by the FDA is merely a single step among a marathon of them that need to take place. Besides, patients who take better responsibility for their own health decisions typically have better outcomes too.

New York Times March 22, 2007 Registration Required

The Ledger March 22, 2007