Thursday, July 10, 2008

FDA Says Safety First

Both the Wall Street Journal, their affiliated health blog and Pharm. Executive Magazine addresses the slowing down of drugs approved. Pharm. Executive Magazine tells us of the FDA's new policy, from labeling regulations and post marketing strategies. While, the Wall Street Journal's article gives a sweeping historical overview of the FDA's "swinging pendulum" between more lax or more conservative acceptance of drugs. Currently, with a more safety-oriented approach, the FDA is taking more precautions in approving drugs, some which have already been approved overseas. Due to Vioxx's severe side effects, FDA is weighing the potential side effects much more seriously. Last year, the FDA approved only 19 new drugs, the lowest number in 24 years. Despite this low number of drugs being approved, perhaps, doctors will feel more comfortable prescribing these drugs to their patients, leading to a greater financial success in the new drugs that do come to market.

So what does this mean for pharmaceutical companies?

Another restructuring, but this one focused on drug development and pipeline drugs. Some companies such as Schering-Plough are scrapping drugs before the expensive clinical trials begin, doubting the drug's approval by the FDA. Pharmaceutical companies will certainly be doing rigorous testing of whatever drug they look to approve. Yet, the article ends with the fact that some experimental new drugs that are being denied are costing people their health.
Tell us what you think.
Is the FDA's stringent approval policy a good thing?

No comments: