A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers
FDA Law Blog
NOVEMBER 16, 2021
5376 that would implement the “Program” get pretty complicated from there. In 2025, the Secretary would select no more than 10, 15 in 2026, 15 in 2027, and 20 in 2028 and subsequent years. There would also be a renegotiation process beginning in 2027 for selected drugs for which factors that the Secretary considered had changed.
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