Rep. Waxman Says Generic Biotech Drug Legislation Likely Will Not Reach House Floor This Year

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 11 Sep 2007 - 19:00 PDT

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Rep. Henry Waxman (D-Calif.) in a speech before the Generic Pharmaceutical Association on Thursday said legislation (HR 1038) that would allow FDA to approve generic versions of biotechnology drugs is unlikely to reach the House floor this year, CQ HealthBeat reports (Bartolf, CQ HealthBeat, 9/6).

The bill would allow FDA to approve "comparable" and "interchangeable" generic versions of biotech medications through an "abbreviated" process. Companies that seek to market comparable generic versions of biotech medications would have to prove that their treatments have active ingredients "similar" to those of the brand-name versions. Companies that seek to market interchangeable generic biotech medications would have to prove that their treatments have molecular structures "comparable" to those of the brand-name versions and that their treatments have the same effects as the brand-name versions in all patients.

The legislation would not specifically require companies that seek to market comparable or interchangeable generic biotech medications to conduct clinical trials. However, the legislation would allow FDA to require trials on a case-by-case basis (Kaiser Daily Health Policy Report, 5/3).

Waxman said that although "enormous strides" have been made since he introduced the measure in February, scheduling issues would prevent the bill from being included in House legislation (HR 2900) that would overhaul FDA and reauthorize prescription drug user fees. Waxman tried to attach the generic biotech measure to the FDA overhaul bill in July but was unsuccessful. Andrea Hofelich, a spokesperson for GPhA, said the "momentum is there to keep the process moving forward," and congressional support for the legislation remains strong.

Jim Greenwood, president of the Biotechnology Industry Organization, said Waxman's comments represent "more good news" for the biotech industry, adding that he believes it is "very unlikely" that the Senate would include generic biotech drug legislation (S 1695) in its FDA overhaul bill (Bartolf, CQ HealthBeat, 9/6).

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