BIO Uses Biomanufacturing Executive Order To Argue Against Waiving Patent Protections

The Biotechnology Industry Organization is using the president’s recent executive order on domestic biomanufacturing as ammunition against a waiver of patent protections for COVID-19 treatments and diagnostics abroad. The World Trade Organization in June partially waived patent protections for COVID-19 vaccines , and WTO members are considering expanding that waiver to coronavirus treatments and diagnostics. The Biden administration backed the initial waiver to the Trade-Related Aspects of Intellectual Property Rights, but it has kept quiet about expanding the TRIPS waiver...
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FDA Week - 09/30/2022
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Executive Order Could Lead To Big Subsidies For Domestic Biopharmaceutical Manufacturing

The president’s executive order on biomanufacturing could lead to a major law that bolsters domestic manufacturing of biologics in the same way that a 2021 executive order on supply chains precipitated the recently enacted law to give $52 billion in subsidies to domestic computer chip makers to bolster domestic manufacturing of semiconductors in the United States, according to executives at biopharmaceutical companies. The executive order also could be the beginning of a move away from the government paying to build...
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Clean User Fee Deal Spurs Debate On Policy Riders For Year-End Bill

Lawmakers’ recent deal to move forward on a clean reauthorization of FDA user fee programs in the upcoming stop-gap spending bill has sparked a lobbying battle over which of the stripped user fee policy riders -- such as those giving FDA authority over dietary supplements, laboratory-developed tests and cosmetics -- should be added to an expected year-end omnibus package, and what form those riders should take. FDA, stakeholders and lawmakers spent years negotiating the riders, and some of those hard-fought...
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FDA Week - 09/30/2022
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Vol. 28, No. 39
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CMS Approves OR, MA Continuous Enrollment, Health-Related Social Needs Demos

CMS on Wednesday (Sept. 28) approved two health-related social needs and continuous enrollment demonstrations it dubbed as groundbreaking -- one in Oregon to allow children eligible for Medicaid coverage to be continuously enrolled through age six, and older beneficiaries to keep their coverage for two years regardless of income fluctuations, and another in Massachusetts that would provide a year of coverage for Medicaid and CHIP beneficiaries that leave correctional settings and two years of coverage for the chronically homeless. The...
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