MACPAC Poised To Recommend Higher Rebates For Fast-Approval Drugs

Though they will not vote until Friday (April 9), nearly all congressional Medicaid adviser said Thursday that they support recommendations to hike Medicaid rebates for accelerated approval drugs and to impose additional inflationary rebates on companies that miss deadlines for post-market studies of those drugs. The draft recommendations by the Medicaid and CHIP Payment Access Commission leave it to Congress to determine how much rebates should be increased, whether some drugs should be excluded and at what point inflationary rebates...
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IDP Issue: 
Inside Drug Pricing - 04/12/2021
IDP Volume: 
Vol. 4, No. 15

FDA: Inspection Lag Puts Generic Drug Exclusivity At Risk

In its latest guidance for the generic drug industry, FDA indicates that due to the backlog of onsite facility inspections, some generic drug makers might not be able to meet requirements for tentative approval for their drugs and as a result might not qualify for 180-day exclusivity, which raises questions about whether FDA will use its authority to disqualify companies from exclusivity, and if so, how the agency would decide which companies qualify and which don’t. While some sources said...
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FDA Issue: 
FDA Week - 04/09/2021
FDA Volume: 
Vol. 27, No. 14


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