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Under the pathway, manufacturers can use safety and efficacy data from existing products in their applications for their own products. This product would be a more potent prescription version than the OTCs, Casberg notes. Starting in 2026, the provision will affect 10 Part D drugs.
The initial list, which takes effect in 2026, has the potential to roil formularies since it includes a mix of high-volume, preferred brands and a group of high-cost specialty drugs for autoimmune conditions (psoriasis) and cancer. In both cases, a shift in formulary placement could lower prescription volumes and reduce member utilization.
Inflation Reduction Act Speaking during the keynote panel “FDA & ARPA-H: Life Sciences, Biopharma & Medtech Priorities in a New Year”, Califf discussed the Inflation Reduction Act of August 2022, which aims to lower prescription drug prices.
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