This Week at FDA: Lawmakers promote research bills, Biden works to reschedule marijuana, upcoming FDA meetings
Editor's Note: This article was updated 21 May to reflect Bristol Myers Squibb's acquisition of Juno Therapeutics.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, US lawmakers forwarded several bills on medical research, the Biden Administration took concrete steps to down-classify marijuana, and FDA announced several important meetings next week.
Members of the House Energy and Commerce Committee’s Subcommittee on Health met this week to discuss 21 bills, many of which deal with medical research. They forwarded to the full committee legislation to facilitate research on cancer drugs for children; to require the Department of Health and Human Services (HHS) to raise awareness of the potential risks and benefits of human cell and tissue product transplants; and enhance National Institutes of Health (NIH) research and programs on autism.
The Biden Administration took a major step toward down-classifying marijuana from a Schedule I drug to a Schedule III drug under the Controlled Substances Act. In its notice, the department emphasized the medical use of marijuana.
The US Food and Drug Administration is hosting several important meetings next week including a two-day public workshop on 20-21 May to discuss its science and research initiatives for generic drugs. The meeting fulfills a commitment made under the Generic Drug User Fee Amendments (GDUFA III) deal, according to the agency. FDA is seeking input from stakeholders, including industry and researchers, on topics such as nitrosamine drug substance-related impurities, combination products, and predictive tools.
FDA is also hosting another town hall on medical device sterilization on 23 May. The agency previously has used town halls to discuss how manufacturers can move away from sterilizing their products with ethylene oxide (ETO), which has come under increasing restrictions from the Environmental Protection Agency (EPA) as a pollutant and potential carcinogen.
Several advisory committee meetings are on the FDA’s calendar, including a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on 22 May. Panel experts will discuss the impact of implementing sections of the 2017 FDA Reauthorization Act that require certain pediatric cancer drugs to be assessed based on their molecular mechanism of action rather than clinical indication.
The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet on 23 May to discuss and vote on whether Guardant Health's Shield colorectal cancer test meets FDA requirements. The in vitro diagnostic test is intended to screen patients 45 years of age and older who are at average risk of colorectal cancer.
The Endocrinologic and Metabolic Drugs Advisory Committee will meet on 24 May to discuss Novo Nordisk's biologics license application for NNC0148-0287 injection (insulin icodec) to improve glycemic control in adults with diabetes mellitus.
Drugs & Biologics
FDA announced it plans to host a webinar on 26 June to discuss a recently finalized rule that goes into effect 20 May on direct-to-consumer prescription drug advertising. The rule requires major statements in ads to be presented in a clear, conspicuous, and neutral manner. The agency intends to provide an overview of topics such as different categories and types of promotion and their regulatory requirements.
FDA also announced it is hosting a two-day in-person workshop 11-12 July at its White Oak headquarters to discuss transplacental transfer of drug and biological products with immunosuppressive properties and their potential clinical impact on developing fetuses and newborn infants. The agency plans to discuss potential gaps in knowledge on how immunosuppressive drugs and biologics may affect utero exposure and how to collect relevant data.
Bristol Myers Squibb's (BMS) drug Breyanzi (lisocabtagene maraleucel) has received accelerated approval from FDA. It was acquired as part of BMS' purchase of Celgene which bought Juno Therapeutics, and is approved to treat relapsed or refractory follicular lymphoma in adults who have received two or more treatments before. The decision was based on the results of a Phase 2, open-label, multicenter, single-arm trial.
Amgen's Imdelltra (tarlatamab-dlle) also received accelerated approval. Imdelltra is approved to treat extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. It was reviewed under Project Orbis, which allowed the agency to review it concurrently with the Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), Israel’s Ministry of Health (IMoH), and UK Medicines and Healthcare products Regulatory Agency (MHRA).
The Center for Biologics Evaluation and Research (CBER) published its annual report on deviations and unexpected events in manufacturing biological products, and nonreproductive human cells, tissues, and cellular and tissue-based products (HCT/P). The report covers deviation reporting from manufacturers between October 2022 and September 2023.
FDA also published new and revised draft product-specific guidances. The guidances provide product-specific recommendations, including how to design bioequivalence studies for product-specific abbreviated new drug applications (ANDAs).
Medtech
In the ongoing saga over faulty plastic syringes from China, FDA announced an import alert for Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group for failing to meet its quality system requirements and not preventing Chinese-made syringes from entering the US. The agency has added the companies to its list of companies from whom users should not use plastic syringes unless it is absolutely necessary.
FDA issued a safety communication warning the public to not use Cue Health’s COVID-19 tests for home and over-the-counter (OTC) and COVID-19 tests for use in patient care settings because they may give false results. The warning comes after the agency handed the company a warning letter on 10 May after inspectors found it had changed the tests, which could reduce their reliability.
FDA updated the public on the ongoing recall of Philips Respironics’ Trilogy Evo Continuous Ventilators due to potential power malfunctions caused by a software glitch. The agency said the company has developed a software update to address the issue.
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