FDA TO EXEMPT PEPFAR DRUGS FROM USER FEES

The FDA is exempting drugs that will be used for the President's Emergency Plan for AIDS Relief (PEPFAR) from Prescription Drug User Fee Act fees to lessen the financial difficulties associated with developing the products, an agency guidance says.

Most therapies included under the PEPFAR will either not be charged with fees in the first place or will qualify for a waiver, the guidance said. The products include fixed-dose combination (FDC) and co-packaged versions of previously approved therapies to treat HIV/AIDS.

In 2004, the FDA released a guidance on FDC and co-packaged drug treatments for HIV/AIDS, including preemptive attachments with examples of acceptable treatments. Any product listed in Attachment B of the fixed-dose guidance will qualify for fee exemption under the agency's public health benefit waiver, the new guidance says.

Drugs developed for the PEPFAR program could also qualify for the "barrier-to-innovation" waiver of application fees under the following conditions:

The products are included in Attachment B of the fixed-dose guidance;

The company only obtains tentative approval in the U.S. for the product; and/or

The company confirms it would make the product available at competitive prices in at least one of the 15 designated PEPFAR countries.

The guidance can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/05d-0091-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0091-gdl0002.pdf).