FDA Officials: Serology COVID-19 Tests Should Be Pre-Authorized

Top FDA device center officials over the weekend acknowledged early agency missteps in regulating COVID-19 serology tests and said moving forward the government should not let serology tests enter the market unless they are authorized by FDA. FDA device center head Jeff Shuren and diagnostics shop director Timothy Stenzel proposed five steps the federal government should take to ensure the availability and accuracy of antibody testing in future national health emergencies, in a Saturday (Feb. 13) New England Journal of...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 02/19/2021
FDA Volume: 
Vol. 27, No. 7
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CBO: E&C’s Medicaid Rebate Measure Would Save $15.9 Billion

House Energy & Commerce legislation to remove the cap on inflationary drug rebates in Medicaid would save taxpayers $15.9 billion over a decade, according to the Congressional Budget Office. Medicaid requires a minimum 23% rebate on brand drugs, and companies pay an additional inflation rebate when they raise prices faster than inflation. That inflationary rebate is currently capped at 100% of the Average Manufacturer Price to avoid making drug companies pay rebates greater than the price of drugs. The Energy...
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InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 02/18/2021
CMS Volume: 
Vol. 24, No. 7
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Senate Health Schedules Confirmation Hearing For HHS Nominee Becerra

After a month of pressure from advocates who blamed Republicans for holding up the process, the Senate health committee has scheduled a confirmation hearing for HHS Secretary nominee Xavier Becerra on Feb. 23, and Senate Finance committee staff said they expect to announce a hearing for him later this week. Biden’s nomination of California Attorney General Becerra in December was largely cheered by Democrats and many health care stakeholders, who championed his involvement in lowering the cost of COVID-19 drugs...
Article Type: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 02/19/2021
FDA Volume: 
Vol. 27, No. 7
CMS Issue: 
Inside CMS - 02/18/2021
CMS Volume: 
Vol. 24, No. 7






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