Senate Shift Could Mean ‘Renewed’ Attention on Generic Drugs

The "changing political dynamics in the Senate" could indicate a "renewed effort on" reforming the 1984 Hatch-Waxman Act, which governs drug patents, CongressDaily/AM reports (Fulton, CongressDaily/AM, 6/7). The Hatch-Waxman Act sped approval for generic drugs while adding five years to the patent life of brand name medicines. Although there have been no "official discussions" on the issue, members of the Senate Health Education, Labor and Pensions committee as well as the Commerce and Judiciary committees have "expressed interest" in reforming the law. Earlier this year, Sen. Patrick Leahy (D-Vt.), the new Judiciary Committee chair, introduced a bill that would require generic drug companies to submit to the Federal Trade Commission and Justice Department terms of deals reached with their brand-name rivals that result in keeping generic products off the market. Leahy intends to hold oversight hearings on the issue this year (CongressDaily/AM, 6/7). The FTC has received the go-ahead from the Bush administration to investigate such agreements. In addition, Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.) have introduced a bill (S 812) to "speed generic drugs to market." Reps. Jo Ann Emerson (R-Mo.) and Sherrod Brown (D-Ohio) also have introduced a similar bill (HR 1862). Further, the House Energy and Commerce Committee is considering changes to the Hatch-Waxman law as part of the Medicare prescription drug benefit bill it is working on. Sources told CongressDaily/AM that "removing some barriers" generic drug manufacturers face when trying to get their versions to market "would save the government money" when paying for drugs under Medicare. The committee plans to hold a hearing next Wednesday on medications, both generic and prescription (CongressDaily/AM, 6/7).