US FDA’s ‘Active Moiety’ Approach On NCE Exclusivity Codified Under Drug Pricing Legislation
Measure clarifies the meaning of new chemical entity by replacing the term ‘active ingredient,’ which encompasses esters and salts, with ‘active moiety’ as defined by the FDA; legal experts are skeptical the measure will generate cost savings and say it gives the agency wide latitude to make future changes in eligibility for 5-year exclusivity.
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Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.
They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing.
Senate and House will likely have to reconcile differences on drug pricing legislation as Senate HELP Committee seeks public comment on a discussion draft.