This Week at FDA: Congress takes up FDA bills; CDRH leans in for more authority on shortages

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week the US House and Senate held hearings on some major pieces of health care legislation, the FDA drafted two guidances on human gene therapy products and chimeric antigen receptor (CAR) T cell products, and vaccine manufacturers have submitted applications to authorize another COVID- 19 booster shots.

Lawmakers on the Senate Health, Energy, Labor and Pensions (HELP) Committee passed the PREVENT Pandemics Act on Tuesday, which includes provisions that would require the FDA to publish a slew of guidance and better prepare for the next pandemic. On the House side, the Energy and Commerce Committee held a hearing on riders for the FDA user fee reauthorization bill that include the 21st Century Cures 2.0 bill and President Biden’s proposed ARPA-H agency.

Medical Devices

The FDA published a fact sheet on mitigating medical device shortages during public health emergencies. The sheet outlines some of the lessons learned from the COVID-19 pandemic, particularly as they pertain to the authority to require some manufacturers to provide the agency with information on possible supply chain interruptions, as was granted by the CARES Act in March 2020. Still , according to the fact sheet, CDRH would be better situated to protect public health if it had the authority to require manufacturers to provide notice of any potential device shortage, regardless of whether a public health emergency was active.

The FDA also continues to issue recalls for COVID-19 tests that have been found to give false results – with three new recalls listed in the last week alone.

Google has partnered with electronic health records software company Meditech to embed its clinical software tools into Meditech’s Expanse record-keeping system, according to this report from STAT. The move could lead to Google’s suite of software being integrated into hospital systems.

Drugs and Biologics

The FDA published its FY2022 over the counter (OTC) monograph drug user fee program (OMUFA) fee schedule in which facilities fees would go up about 20%. The higher-than-expected fees were based on a perfect storm of fewer fee-liable facilities in FY2022 compared to FY2021 combined with the statutory need to raise a specific amount of funding under the Act. The large increase in facility fee risks putting some companies out of business and may lead the agency to readjust the fees, an industry source told Focus.

Both Pfizer and Moderna have requested the FDA authorize a second booster for their COVID-19 vaccines after presenting data that immunity from Comirnaty and Spikevax, respectively, wanes six months after the first booster.
Lawmakers in the Senate Finance committee duked it out over prescription drug prices this week – watch the entire hearing here, if you like. While Democrats advocated for negotiating lower Medicare drug prices, Republicans pushed back at the idea calling for it price controls.

What we’re reading

AstraZeneca is considering abandoning efforts to get its COVID-19 vaccine approved in the US if it continues to face regulatory difficulty, according to original reporting in the Financial Times. You can read an open-access version from Reuters here.

The FDA published its annual report on its medical countermeasures (MCMs) program report this week. The agency works with the Department of Defense to maintain the program and the report details of those medical countermeasure activities. This year’s update provides additional information on FDA’s response to COVID-19, and a new infographic that updates its efforts for the start of the public health emergency.

Ellen Sigal, the founder of Friends of Cancer Research (FOCR), reflects on 10 years of the FDA’s breakthrough therapy designation in Nature Reviews Drug Discovery, a publication in the Nature group. She says the program has gone far beyond what she had imagined a decade ago in spurring innovation in new cancer therapies.

On the topic of cancer drugs, a new analysis in BioMed Central looks at the increasing number of anticancer drugs that have been approved based on the results of a single-arm trial.

What’s we’re watching

The FDA is holding a public meeting on March 22 titled “Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act.” It will include an independent third-party contractor presentation on BsUFA II and take in stakeholder feedback.

On the same day, the Duke Margolis Center for Health Policy is holding a webinar on artificial intelligence/machine learning (AI/ML). It will address frameworks for regulating AI/ML products, good machine learning practices (GMLP) and postmarket evaluation. It will also include a fireside chat with Jeffrey E. Shuren, director of CDRH.

Also up for CDRH is its periodic virtual town hall for COVID-19 test developers on 23 March. As usual, the agency hopes to address technical questions about the development and validation of tests for SARS-CoV-2.

FDA’s CDER and its Biomarker Working Group is holding a virtual workshop between 23-24 March to discuss multi-component biomarker concepts and terminology, and address gaps in those concepts and terminologies.

The Office of Management and Budget (OMB) reports that it received a draft guidance from the FDA on 11 March titled, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The executive agency is reviewing the guidance.

Rep. Michael Burgess (R-TX), reportedly is submitting a bill (HR 7084) to the House Energy and Commerce Committee. The initial language of the bill seems to require that all connected medical devices need to show reasonable assurance of safety and effectiveness throughout the product’s lifecycle.

© 2022 Regulatory Affairs Professionals Society.

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