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The Latest in Regulatory and Reimbursement
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With just days to spare before the end of the fiscal year, the FDA’s user fee agreements have been reauthorized for another five years. The agency has been busy updating a COVID-19 EUA guidance document and finalizing a highly anticipated digital health guidance and proposed rule on investigational drug reporting requirements. Biosimilars may see a temporary increase in Medicare payments while Medicare’s telehealth services have been under review by the U.S. Government Accountability Office.
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Congress Reauthorizes FDA User Fees
On September 30, Congress passed a clean five-year reauthorization of the FDA’s user fee agreements. Biocom California’s thoughts on the reauthorizations can be found here.
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FDA Releases Updated COVID-19 EUA Guidance
The revised guidance removes several technology types from the priority list and narrows the prioritization of Emergency Use Authorization requests.
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FDA Finalizes Clinical Decision Support Guidance
The finalized Clinical Decision Support (CDS) Software Guidance, initially released in September 2019, highlights the types of CDS software functions excluded from the scope of the agency’s oversight.
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FDA Accepts First ISTAND Pilot Program Submission
CDER and CBER recently accepted the first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program, which supports the development of novel drug development tools.
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OTAT Renamed with New Authority
The FDA Office of Tissues and Advanced Therapies (OTAT), which oversees the regulation of cell and gene therapies, is now a Super Office renamed the Office of Therapeutic Products (OTP).
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Inaugural ARPA-H Director Tapped
Former DARPA scientist, Dr. Renee Wegrzyn, will be appointed by the Biden Administration to lead the newly established Advanced Research Projects Agency for Health (ARPA-H).
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Right to Try Act Reporting Requirements Finalized
FDA issued a final rule outlining the annual summary reporting requirements for investigational drugs supplied under the Right to Try Act. The final rule, effective November 14, 2022, specifies that the summary include the number of doses supplied, the number of patients treated, the drug’s use, and any serious adverse events from the drug.
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Some Biosimilars See a Temporary Increase in Medicare Part B Payment
Under the Inflation Reduction Act, certain biosimilar biological products will be subject to an increased Medicare Part B payment that is the average sales price (ASP) plus 8 percent of the ASP (instead of the usual 6 percent) for a
five-year period.
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U.S. GAO Releases Report on Telehealth Services
In a recent report, the U.S. Government Accountability Office (GAO) reviewed Medicare’s telehealth services under the waivers and flexibilities issued by HHS in March 2020 by analyzing claims data from 2019 through 2020. The office’s report outlines three recommendations for CMS to strengthen its telehealth oversight.
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Upcoming Regulatory and Reimbursement Events:
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Member Milestones
Retevmo (selpercatinib) from Eli Lilly and Company was recently granted FDA accelerated approval for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion.
TRACON Pharmaceuticals was granted FDA fast track designation for the development of envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
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Biocom California
For over 27 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over 1,600 companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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