US FDA, USP Cooperate On Small Molecule Drug Monograph Updates To Speed ANDAs
Generic applicants can request monograph changes while FDA assessment is ongoing.
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HHS lacks authority to require drug price disclosures in TV ads, judge rules. Even if legislation were to explicitly give the Trump Administration such authority, First Amendment issues would still linger.
Remarks to reporters prompt surprise and confusion among stakeholders and likely reflect the president’s impatience with the pace of regulatory and legislative pricing reforms.
Policymakers should clarify link between high drug prices and innovation and figure out how to “rebalance” high prices with non-price innovation incentives before proceeding with policies aimed directly at lowering prices, Conti and David propose in the Health Affairs Blog.