FDA Draft Guidance Reviews Priority-Review Voucher Plan

October 23, 2008
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

Rockville, MD (Oct. 23)-The US Food and Drug Administration released a draft guidance that reviews the agency’s plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases. The document, Guidance for Industry: Tropical Disease Priority Review Vouchers, explains the agency’s proposed procedures for granting vouchers and how sponsors may use the vouchers.

A sponsor can earn a priority-review voucher when it applies for a new drug or biologic designed to treat tropical diseases such as malaria, tuberculosis, or cholera (see the draft guidance for the full list). The voucher may be used by the sponsor to obtain a priority review for a different application; and a voucher can be transferred to another sponsor. The sponsor must notify FDA it intends to use the voucher at least one year in advance of submitting the application.

The plan stems from the new section 524 of the Food, Drug, and Cosmetic Act (FDCA), which was added in the Food and Drug Administration Amendments Act of 2007 (FDAAA). Under section 524, a voucher can be used to obtain a priority review for any drug application under section 505(b)(1) of the FDCA or section 351 of the Public Health Service Act. Drug applications cannot include an active pharmaceutical ingredient that has been previously approved in any other application under section 505(b)(1) the Act or section 351 of the PHS Act.

The program was designed to encourage drug development for diseases found in poor and developing countries, as the guidance states “there has been remarkably little progress over the past 50 years in development of drugs for these diseases.”

Comments may be submitted online at http://www.regulations.gov or by writing the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, RM 1061, Rockville, MD 20852. View the full text of the guidance here.