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Six physician groups support new legislation providing FDA authority on biologics
Six groups that represent biologic prescribers sent a letter to Sen. Lamar Alexander, R-Tenn., chairman of the U.S. Senate Committee on Health, Education, Labor and Pensions, and Sen. Patty Murray, D-Wash., a ranking member of the committee, to commend them on the bipartisan sponsorship of Section 11 of S. 2700, according to a recent release.
Section 11 of S. 2700 reportedly is part of the 21st Century Cures Act, which ensures the FDA will have full authority over the identity and standards of quality for biologics and biosimilars. The six groups that commended the two senators were: the Alliance for Patient Access, the American Association of Clinical Endocrinologists, the American College of Rheumatology, the Biologics Prescribers Collaborative, the Coalition of State Rheumatology Organizations and the Endocrine Society.
According to the release, the U.S. Pharmacopia had been responsible for the official naming and standard of quality for small-molecule drugs, but with Section 11, the FDA reportedly will be able to obtain authority over the biologics and biosimilars.
The Biologics Prescribers Collaborative and other stakeholder organizations are in support of Section 11, which will reportedly back the FDA’s efforts to ensure that the biosimilar market is safe and will scientifically and legislatively recognize the differences between traditional drugs and biologics.
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