Biotech Values

[DewDiligence]

Re: Might Wyeth v. Levine influence FDA?

Hi, FL. You’ve laid out a fascinating thesis. The circumstantial evidence with respect to timing does seem to support your contention of there being a connection between Bush’s attempt to rein in tort litigation and the FDA’s marked slowdown in drug approvals.

However, despite the circumstantial evidence in support of your contention, I consider it a bit far-fetched that FDA staff reviewers and mid-level managers in the Division of New Drugs evaluate their decisions on drug applications in a broad societal context. Moreover, if you want to argue that a go-slow policy was dictated from the highest levels of the FDA, you have to explain why people like John Jenkins and Janet Woodcock have repeatedly stated on the record that there has been no change in FDA policy on drug approvals. (Their contention is that there have been fewer drug approvals in the past few years because there have been fewer high-quality applications.)

Returning to your main question: If the confluence in time between Bush’s policy on tort litigation and FDA conservatism on drug applications is but a coincidence, it follows that the Wyeth v. Levine case is not apt to change anything for the better at the FDA.

In short, I respectfully disagree with your thesis even as I commend you for having thought of it. I’ll be interested to hear what other readers on this board have to say about this. Regards, Dew