HHS lacks authority to approve Vermont Pharmacy Discount Program demonstration project extending Medicaid drug rebate structure to 70,000 beneficiaries without drug coverage, D.C. federal appeals court rules June 8. The opinion reverses Jan. 18 D.C. federal court decision denying the Pharmaceutical Research & Manufacturers of America's request for a preliminary injunction against the program (1"The Pink Sheet" Jan. 29, p. 7). "Because Congress imposed the rebate requirement in order to reduce the cost of the Medicaid program, and because no Medicaid funds are expended under the Vermont demonstration project and thus no Medicaid savings produced by the required rebates, we conclude that the department lacked the authority to approve the project," the appeals court says
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
