FDA Week - 12/07/2018

FTC Ready To Help FDA Stop Petition Abuses But Doesn’t Say How

By John Wilkerson / December 6, 2018 at 1:10 PM
The Federal Trade Commission says it stands ready to help FDA thwart citizen petition abuses aimed at delaying generic and biosimilar competition, but FTC’s comments to FDA offer no insights into how the antitrust enforcer would improve upon its past, limited performance in curtailing citizen petition abuses. FDA warned brand drug makers in a recently published draft guidance that it will alert the FTC to citizen petition abuses. The guidance describes criteria for determining petition abuses. “[T]he agency stands ready...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.