STAT+: Lawmakers introduce bill to require drugmakers to provide key info to both FDA and U.S. Patent Office

A new bill seeks to have the FDA and the U.S. Patent Office coordinate efforts to prevent drugmakers from unfairly extending monopolies on their medicines.

Sep 14, 2023 - 20:00
STAT+: Lawmakers introduce bill to require drugmakers to provide key info to both FDA and U.S. Patent Office

Amid concerns over monopolies held by drugmakers, a bipartisan group of lawmakers introduced a bill that would require the companies to certify they have provided the same information to different federal government agencies when seeking marketing approval and patent protection.

The goal is to ensure the Food and Drug Administration and the U.S. Patent and Trademark Office coordinate efforts to prevent pharmaceutical companies from unfairly extending monopolies on their medicines, according to Sen. Maggie Hassan (D-N.H.), who spearheaded the legislation.

The bill emerges two years after the Biden administration issued an executive order directing the agencies to work together to promote more competition and lower drug prices. The move came in response to complaints that drug companies regularly file inconsequential claims to win extra patent protection and misuse patent laws to inhibit or delay competition.

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