Premier statement on FDA action to address the use of citizen petitions to delay market competition of generics and biosimilars

Sept. 19, 2019

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. The 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.

Expanded Access to Experimental Biologics Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials. The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.