FDA ISSUES GUIDANCE ON COMBINATION HIV DRUG APPLICATIONS

The FDA has issued a guidance for industry clarifying whether companies submitting drug applications for fixed-dose combination (FDC) and co-packaged versions of previously approved antiretroviral drugs for treating HIV/AIDS must pay user fees under the Prescription Drug User Fee Act, or whether they qualify for a waiver.

Also, many of the applications, products and establishments may be eligible for a public health or a barrier-to-innovation waiver, the guidance says. The FDA expects that most of the applications for FDC and co-packaged HIV therapies proposed for use in the President's Emergency Plan for AIDS Relief (PEPFAR) will either not be assessed fees in or will qualify for a waiver.

In May 2004, to encourage applicants to submit applications for HIV combination therapies for use under PEPFAR, the FDA issued a draft guidance on FDC and co-packaged HIV drugs providing examples of acceptable combinations and explaining that the Federal Food, Drug and Cosmetic Act provides for certain circumstances in which the FDA can waive user fees.

The guidance can be viewed at www.fda.gov/cder/guidance/7265fnl.pdf.