Reply #271: Good info. I'd like to add a few bits.

[mzmolly]

http://www.boston.com/news/globe/editorial_opinion/oped/articles/2005/03/10/what_ails_the_fda_payola/

"Why is the nation's most important regulatory agency appeasing the pharmaceutical industry instead of protecting the public? One answer is that it is on the industry's payroll. Literally.

Since 1992, by an act of Congress, drug companies pay the FDA ''user fees," which are earmarked almost entirely for speeding up drug approvals. ...

Even worse, the 18 standing advisory committees of outside experts who help the agency decide whether drugs should be approved include paid consultants to drug companies. They are supposed to recuse themselves from decisions that directly affect the companies they work for, but that rule is regularly waived on the dubious grounds that their expertise is uniquely valuable. (Imagine judges not recusing themselves from cases in which they have a financial stake on the grounds that their expertise is invaluable!) The advisory committee that originally recommended approval of Vioxx, for example, consisted of six people, four of whom had received waivers because of their ''potential for a conflict of interest."

http://www.msnbc.msn.com/id/10088939/site/newsweek/

The FDA is being exposed as something much less than it’s supposed to be. It’s pretty much a captive of the industry it is supposed to be regulating, and it’s a captive to the right-wing ideology of the Bush administration.

How is the FDA captive to the pharmaceutical industry?

The takeover by the pharmaceutical industry they are supposed to regulate began with PDUFA. The user fees, which is a terrible term because the public—not the drug industry—should be the users of the FDA, are contingent on the industry. They provide over half of the resources of the FDA’s Drug Evaluation Center. So this part of the agency is directly dependent on the drug industry it is regulating. We’re also seeing top-down enforcement of the industry, fierce posturing of the FDA officials and this leaning on the scales to further the agenda of the religious right. We started with corporate problems and now have all kinds of ideological problems in addition.

I'm posting this to share as well as have on the record in this discussion.

Thanks. :hi: