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Latest From Legislation
At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling.
Outgoing Biotechnology Innovation Organization CEO suggests consideration of price inflation caps instead of 'big discounts' in Medicare Part D and says that industry should fund a cap on beneficiary out-of-pocket costs in the program.
In a marked departure from previous years, budget proposal offers few specifics on cost reductions, but the $135bn savings estimate is a tacit endorsement of the Grassley-Wyden bill in the Senate.
President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.
Next round of biomedical innovation legislation provides opportunity to require insurance reimbursement of investigational drugs and related medical services, as well as new incentives for small biotech companies to offer expanded access programs, stakeholders say.
Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.
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