Expert: FDA Needs 'Muscle Behind Its Words' To Curb Citizen Petition Abuse

By Beth Wang / October 18, 2018 at 10:49 AM
Legal experts point to what they view as flaws in FDA's recently announced plan to alert the Federal Trade Commission (FTC) when brand-drug makers use the citizen petition process to delay generics from entering the market. Specifically, one law professor -- who describes the plan as a “threat and shame” approach -- says FDA, while taking a stronger stance, is still putting the onus on others to take action rather than using its own tools to tackle the issue head...


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.