FDA Offers PDUFA Waivers for Antiretroviral HIV Drugs

Innovative antiretroviral HIV drugs may qualify for PDUFA fee waivers or refunds if the fee would be a significant barrier to development, according to new FDA draft guidance aimed at implementing the President’s Emergency Plan for AIDS Relief.

Valid reasons to claim the PDUFA fee is a significant barrier include limited resources and “other circumstances” including when the applicant certifies it will make the product available at competitive prices under the Emergency Plan for AIDS Relief, the agency said.

Other valid circumstances are when applicants submit an application for a product for HIV treatment from among the examples listed in the agency’s 2006 fixed combination guidance and when the applicant only seeks a tentative approval in the U.S. due to patents or exclusivity on the innovator product.