House Likely Will Not Have Time For Generic Biotechnology Drug Legislation

Armen Hareyan's picture

Generic Biotechnology Drug Legislation


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, CongressDailyreports. The subcommittee met to discuss ideas for generic biotech druglegislation, but members "are far from drawing up language," accordingto CongressDaily.

A committee aide said the panelwill continue to meet informally to work on the legislation. Membersmust decide on FDA approval standards, requirements for generic biotechdrug makers and the length of time that brand-name drug companies willbe 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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