Premier Statement on FDA Action to Address the Use of Citizen Petitions to Delay Market Competition of Generics and Biosimilars

Members of Premier applaud the Food and Drug Administration (FDA) for releasing revised draft guidance on the use of citizen petitions to delay the market entry of generic medications and biosimilars. As noted by the agency, it’s become all too common for meritless citizen petitions to be filed in a brazen attempt by incumbents to prevent generic and biosimilar competition. The net effect of these efforts is not consumer protection, but a continued stranglehold on market exclusivity that only yields higher prices for patients and payers. Premier further applauds the FDA for referring anticompetitive citizen petitions to the Federal Trade Commission (FTC), and for calling out offenders in the FDA’s annual report to Congress. Today’s announcement is an important step to deter gaming of the regulatory approval process, and is critical to the creation of a more competitive generics and biosimilars marketplace.

--By Blair Childs, Senior Vice President of Public Affairs, Premier