What's the FDA to do? The agency has taken no small amount of criticism in recent years for approving drugs with serious and potentially deadly side effects. Vioxx, Avandia, anemia drugs--just to name a few--have surrounded the agency in controversy. And recent news that the FDA can't guarantee the safety of the U.S. drug supply because its oversight of foreign drug manufacturers is horribly lax hasn't helped.
So it's not surprising that the FDA has clamped down on new drug approvals, green-lighting only 15 New Molecular Entities this year. For companies looking to launch drugs for diseases that already have treatment options, the FDA has raised the bar, demanding that the new drugs aren't just safe and effective, but more effective than currently-available treatments. This, of course, hasn't pleased pharma and biotech companies, which have seen their drugs delayed or rejected. Novartis CEO Daniel Vasella (photo), Schering-Plough CEO Fred Hassan and outgoing Wyeth CEO Bob Essner have all spoken out about that slowdown in approvals, with Essner going as far as saying the FDA is creating "drug monopolies" with its new policy.
The FDA maintains that there's been no change in its policy, and blames the lag in approvals on Big Pharma, which has submitted fewer NDAs this year. However, the agency has increased the number of public drug safety warnings and black box warnings. Yet a recent poll found that 84 percent of the public believe Big Pharma still has too much influence over the FDA. "Whatever action we take, someone's going to be unhappy. That's why it takes a special kind of person to work here," says FDA's Janet Woodcock. "A masochist."
- see this Fortune article for more
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