Senate Bill Would Prevent Safety Label Carve-Outs From Delaying Approvals
Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.
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Senate Drug Pricing Legislation Clears Committee With Generic Exclusivity “Parking” Provision Unchanged
US Senate health committee advanced the Lower Health Care Costs Act with few pharma-related changes. Bill’s drug pricing provisions include the CREATES Act and a requirement that manufacturers report to HHS on price increases.
Finance Committee chairman wants a provision allowing Medicaid to make installment payments for high-cost curative treatments in drug pricing legislation. But Democrats worry such a model might encourage high prices.
Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.