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
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. Under the program, with respect to each price applicability period, the Secretary shall—. (1) The provisions in Section 139001 of H.R.
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