Pharma's faltering - what does it mean for the FDA?

The number of drugs approved by the FDA in 2005 fell to 20 from 36 in 2004:

The lower approval numbers have led some industry executives "to complain that the FDA is denying approval to good new treatments because of the criticism the agency has faced from lawmakers" over Merck's Vioxx, which was pulled from the market over safety concerns, the Times reports. Most of the drugs that did receive FDA approval in 2005 were treatments for relatively rare diseases, while the agency delayed approval for more prominent treatments, such as Bristol-Myers Squibb's diabetes drug Pargluva. FDA and drug companies both "seem to agree that the process for testing and developing new drugs needs improvement," the Times reports.

The FDA doesn't need to approve a certain amount of drugs every year in order to be a viable, competent organization. Clearly we're seeing fallout from Vioxx and other pharmaceutials pulled from the market -- drug companies have ample reason to be more careful with safety questions. That's not a bad thing.

It can quickly turn nasty, however, if the FDA is dragging its feet unnecessarily. In the case of the diabetes drug Pargluva, the AMA gave a warning not to approve without further investigation because a brand new study indicated a higher risk of adverse cardiovascular events. That's a legitimate reason for delaying.

On the other hand, Plan B is languishing eternally because of pure politics. That is unacceptable.

Drug companies are struggling with slumping sales and they won't put up with a spooked FDA for long. If you remember from this post on ethics, certain interest groups are calling for changes in the way the FDA approves drugs, namely by including variables like ethical concerns and cost. Major changes are a definite possibility, and you can't underestimate the impact of a redefined FDA. Thankfully public opinion is with safety and efficacy concerns -- Pharma can't pull a Medicare Part D on this one.