Lawmakers revise generic drug legislation

WASHINGTON — Legislation intended to require the U.S. Food and Drug Administration to act upon applications for generic drugs within 180 days of being filed that are in short supply or when there are too few manufacturers on the market is being revised, a House Energy and Commerce Committee aide told Bloomberg.

H.R. 749 was introduced Jan. 30 by Reps. Gus Bilirakis (R- Fla.) and Kurt Schrader (D-Ore.). It is intended to lower drug prices by having more generic competition. The bill also would create a transferable priority review voucher that the FDA would award to a manufacturer that brings a generic drug to market when a branded product doesn’t have any competition.

 “There are a group of drugs where there’s not a lot of competition where this could help expedite the review process if FDA would be able to meet that 180-day time clock,” David Rosen, an attorney with Foley & Lardner LLP in Washington, told Bloomberg. “Rosen is the chair of the firm’s FDA regulatory practice and was employed at the FDA for 14 years.

However, it is unclear if a 180-day window to approve generic drugs is doable. “The net benefits and practical feasibility of a six-month review are unclear as is, consequently, the market value of a priority review voucher for generic applications,” said Allan Coukell, senior director for health programs at the Pew Charitable Trusts. “Perhaps more important than shortening the duration of review is reducing the number of review cycles.”