WAXMAN, SCHUMER PUSH BIOPHARMACEUTICAL LEGISLATION

Pharmacy Times, Volume 0, 0

Congressional generic drug advocates are pushing for legislationfor creating new fast-track procedures for the FDA to use inapproving generic biopharmaceuticals for marketing. The bill,introduced by Rep Henry Waxman (D, Calif) and Sen CharlesSchumer (D, NY) as the "Access to Life-Saving Medicine Act," couldsave billions of dollars for consumers and taxpayers by establishinga clear, efficient abbreviated pathway for approval of genericversions of such biopharmaceuticals as Epogen (epoetin alfa),Neupogen (filgrastim), and Avonex (interferon β-1a).

Although biopharmaceuticals hold the promise of improving thelives of millions of patients, they can be prohibitively expensive. Notingthat some of these treatments cost up to $100,000 per year, aspokesman for the Generic Pharmaceutical Association (GPhA) saidthat "without generic versions, the costs will cripple the health caresystem and keep needed treatments out of the hands of consumers."

Likening the proposed new legislation to the landmark 1984Hatch-Waxman Act, GPhA President Kathleen Jaeger said thatnow "Congress has the opportunity again to help countlessAmericans access lifesaving biopharmaceuticals that are safe,effective, and affordable."