Thursday, September 06, 2007

The Cost of FDA's Credibility Gap

In previous posts, I have talked about the rising challenges facing the pharmaceutical and biotech industries stemming from FDA's credibility gap. In fact, I think FDA's credibility gap is one of the most pressing business problems for biopharma companies right now and for the foreseeable future.

I want to point you to a story I just wrote, hot off the Internet's virtual presses. The story, "Avandia and the Commercial Impact of FDA's Credibility Gap" can be found on our new website Just register for the free trial, and you can read that, and many other stories we've written for our September issue.

Some of the takeaways from the story are:

1) FDA's credibility is one of the top commercial challenges facing biopharma decision makers.

2) Business leaders are re-thinking their drug development programs as a result of the current environment.

3) The FDA advisory committee on Avandia did more to hurt than help FDA's credibility crisis.

4) FDA is grappling with how to manage incoming information faster and more effectively.

Registration is easy, so go take a look. I'd love to hear thoughts from the investment community about this issue. Also, tell us what you think of the website.


Anonymous said...

I enjoyed RPM Report thoroughly. The FDA definitely is under more scrutiny than ever and its credibility is suffering. Until they find a way to cut all industry ties, and doctors that work for a specific drug company are not also on the FDA panel to approve that drug, the FDA will continually be shrouded in doubt.

Ramsey Baghdadi said...

Thanks for your comment, Cary. Do you think the drug safety reforms in Congress will be enough to do the trick? If not that, then what? Anyone else have an opinion on how FDA can become the singular voice on drug safety issues?