Drug Pricing Measures Clear US Senate Judiciary Committee
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.
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The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.
Agency staff has more freedom to launch investigations under resolutions approved at Commission’s first meeting under new chair. Mergers and rebate walls expected to be major priorities.
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.