Premier Statement on FDA Action to Address the Use of Citizen Petitions to Delay Market Competition of Generics and Biosimilars
By Blair Childs, Senior Vice President of Public Affairs, Premier
Members of Premier applaud the Food and Drug Administration (FDA) for finalizing guidance on the use of citizen petitions to delay the market entry of generic medications and biosimilars. 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 which is not consumer protection, but, rather, a continued stranglehold on market exclusivity that only yields higher prices for patients and payers. 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.
