Hill: FDA lax on conflict-of-interest rules

Medical Marketing and Media, Oct 2000 by Dickinson, James G

The FDAs advisory committee conflict-of interest rules have been lax, says a House Government Reform Committee staff report. While the report hints at a broader scope of FDA problems with managing conflict-of interest issues, it narrows its focus to conflict-of interest issues within the agency's vaccine approval process.

The report identified a "lack of vigilance" on the part of FDA's Vaccines and Related Biological Committee's review of Wyeth Lederle's controversial rotavirus vaccine, Rotashield, in 1997 and 1998. It alleges that three out of five FDA advisory committee members were issued waivers allowing them to recommend approval for the vaccine despite their financial ties to Wyeth Lederle, or two companies developing rival rotavirus vaccines - SmithKline Beecham and Merck.