House Energy and Commerce Subcommittee Hearing Focuses on Market Entry of Generic Medications, USA

Main Category: Pharma Industry / Biotech Industry
Article Date: 23 May 2005 - 0:00 PDT

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Members of the... House Energy and Commerce Health Subcommittee at a hearing on Wednesday said that brand-name pharmaceutical companies are "gaming" the patent system to block market entry of lower-cost generic medications and raised the possibility of legislation to address the issue, CQ HealthBeat reports. Subcommittee Chair Nathan Deal (R-Ga.) said that he called the hearing to examine proposals to increase the use of generic medications, identify obstacles to increased use and determine the need for legislation to remove such obstacles. Deal said that generic pharmaceutical companies could pay user fees to FDA to expedite the approval of generic medications and reduce the backlog of 700 applications at the agency. In addition, Deal said that a tiered copayment system in Medicaid might encourage beneficiaries to use generic medications. He said a recent federal court decision that could limit the ability of generic pharmaceutical companies to clarify the patent status of brand-name medications might "only be solved by legislation." Under the 2003 Medicare law, generic pharmaceutical companies would have had the ability to obtain declaratory judgments in certain cases.

Hatch-Waxman Act Revisions?
At the hearing, Energy and Commerce Committee Chair Joe Barton (R-Texas) raised the possibility of revisions to the 1984 Hatch-Waxman Act to make generic medications more accessible. Generic Pharmaceutical Association President Kathleen Jaeger said that the group supports such revisions, adding that lawmakers should "consider and identify new loopholes" and "take appropriate action." Rep. Sherrod Brown (D-Ohio) said, "The constitution requires the federal government to protect intellectual property. It also requires defined limits on that protection to prevent exploitation of consumers." However, some subcommittee Republicans "expressed some reservations about going too far in spurring generic drug use" because in certain cases brand-name medications might benefit patients more (CQ HealthBeat, 5/18).

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