In a revised draft guidance released on Wednesday, the US Food and Drug Administration (FDA) explains how drugmakers can qualify for user fee waivers for drugs intended to treat human immunodeficiency virus (HIV).
Under Section 736(d) of the Food, Drug, and Cosmetic Act
(FD&C), drugmakers can qualify for waivers or fee reductions for contributing to public health if the fee is considered a "barrier-to-innovation" or if the developer qualifies as a small business.
While FDA says it assesses waiver requests on a case-by-case basis, most fixed-combination HIV therapies and single-entity versions of previously approved HIV therapies proposed for use in the President's Emergency Plan for AIDS Relief (PEPFAR) will qualify for a barrier-to-innovation waiver for both application and postapproval fees.
The revised draft guidance updates a 2007 guidance
entitled User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR
to include single-entity versions of previously approved antiretroviral therapies for the treatment of HIV.
When reviewing barrier-to-innovation fee waiver requests, FDA says it will consider whether the product under development is innovative and whether the fee(s) would be a "significant barrier to the applicant's ability to develop, manufacture, or market" the product.
FDA says it will generally consider products listed in attachment B of its 2006 guidance on fixed-combination HIV drugs
to be innovative "because simplified regiments that will facilitate distribution and patient compliance, particularly in treatment-naïve patients, are needed in developing countries," though the agency says it may not approve fee waivers for some combinations if there are sufficient alternatives available.
FDA also says that while the 2006 guidance is focused on fixed-combination products, the scientific principles in the guidance also apply to single-entity drugs that are components of combinations listed in attachment B.
As for whether the fee is a significant barrier, FDA says it plans to consider HIV products for PEPFAR use to fall under "other circumstances" that would justify a fee waiver.
, Federal Register Notice