Prasugrel Intellectual Bias: FDA Makes Changes, Congress Demands Answers
Recent improvements to FDA's screening process for intellectual conflicts of interest among advisory committee members are likely to be part of the agency's response to a congressional inquiry into the review of Lilly's prasugrel (Effient)
You may also be interested in...
FDA offered Public Citizen’s Sidney Wolfe a seat at the table for discussion, but no vote. Members need to report relevant information about their conflicts in a timely manner, the agency says.
Adjusting advisory committee conflict of interest rules has emerged as a high-priority issue in reauthorizing the drug user fee program, and several bills already propose loosen those rules. Sen. Kay Hagan’s draft FDA reform legislation may prove to be the most loosening proposed to date.
The April 1-2 meeting of the Endocrinologic & Metabolic Drugs Advisory Committee ended in equivocal results for the sponsors involved, but sends an unequivocal message of hope to diabetes drug development companies: the new cardiovascular safety bar adopted by FDA in December is surmountable