House Likely Will Not Have Time For Generic Biotechnology Drug Legislation This Year

Main Category: Biology / Biochemistry
Also Included In: Pharma Industry / Biotech Industry
Article Date: 02 Nov 2007 - 10:00 PDT

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The House will not have enough time this year to develop and pass legislation that would allow FDA to approve generic versions of biotechnology drugs, the House Energy and Commerce Health Subcommittee concluded at a meeting on Wednesday, CongressDaily reports. The subcommittee met to discuss ideas for generic biotech drug legislation, but members "are far from drawing up language," according to CongressDaily.

A committee aide said the panel will continue to meet informally to work on the legislation. Members must decide on FDA approval standards, requirements for generic biotech drug makers and the length of time that brand-name drug companies will be able to retain market exclusivity for their products.

The Senate's version of the legislation would allow 12 years of market exclusivity. The Senate Health Education Labor and Pensions Committee approved its measure in June, but the full Senate is not expected to vote on the bill this year (Edney, CongressDaily, 11/1).

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