This Week at FDA: SCOTUS throws out mifepristone case, House subcommittee passes FDA budget

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 Supreme Court (SCOTUS) rejected a lawsuit challenging FDA's ability to allow mifepristone on the market, House lawmakers moved an FDA FY2025 budget forward, and an inspector general report found FDA's ability to oversee infant formula supply was inadequate.

The biggest news this week came out of SCOTUS, where the justices unanimously decided to throw out a lawsuit that was brought by the Alliance for Hippocratic Medicine to restrict FDA's ability to allow the sale of mifepristone, one of two drugs used for medication abortions. As noted by SCOTUSblog, the justices stated that the group did not have legal standing to challenge FDA's authority.

E&E News reported that the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies passed a $25.9B FY 2025 budget that includes funding for FDA, sending it to the full committee for consideration. The budget was approved on party lines: Republicans argued the bill was fiscally responsible and prevents wasteful spending and Democrats said it would jeopardize food security and FDA's ability to do its work.

The Office of Inspector General at the Department of Health and Human Services (HHS-OIG) published a report that found that the FDA's policies and procedures are inadequate to identify and respond effectively to risks regarding infant formula. The report was commissioned in response to the 2022 infant formula crisis and concluded with nine recommendations to improve the agency's procedures, including better training and reporting.

The Center for Drug Evaluation and Research (CDER) has launched an Emerging Drug Safety Technology Program (EDSTP) that aims to help industry understand how artificial intelligence (AI) and other emerging technologies can be used to conduct pharmacovigilance (PV). In particular, the program is meant to facilitate discussions between industry and CDER on how to use such technologies, allow the FDA to learn more about the technologies, and ultimately, allow it to use that knowledge in its regulatory and policy decisions.

Robert Ball, deputy director of CDER’s Office of Surveillance and Epidemiology, took part in a Q&A to discuss FDA’s experience with AI in PV and what it hopes to achieve with EDSTP. For those who wish to participate in the program, the agency has published a web page detailing the requirements and how to apply.

FDA has published a notice asking individuals and consumer organizations to volunteer or nominate consumer representatives to serve as voting and non-voting members on its advisory committees. The agency listed almost 30 panels that need consumer representatives, and almost all of them need someone to join immediately.

Last week, the FDA agreed with its Vaccines and Related Biologic Products Advisory Committee (VRBPAC) to recommend that manufacturers produce 2024-2025 COVID-19 vaccines based on a monovalent JN.1-lineage coronavirus vaccine composition. This week, the agency added that they should use the KP.2 Strain of JN.1-Lineage if feasible.

Drugs & Biologics

FDA finalized a guidance on what to consider when developing oligonucleotide drugs. The guidance details the agency's thinking when evaluating clinical pharmacology data and recommends when to conduct clinical assessments and what assessments are suitable.

FDA has proposed amending its administrative order that sets requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) use. If finalized, the order would require such drugs with acetaminophen to have a warning that acetaminophen can cause severe skin reactions. Stakeholders can comment on the proposed order on www.regulations.gov under docket no. FDA-2024-N-2422 until 29 July.

FDA's Compounding Quality Center of Excellence announced it is holding a series of virtual discussions with outsourcing facilities to educate them on the agency's oversight of such facilities. The first meeting of the series, scheduled for 18 July, will discuss how to establish outsourcing facilities.

The British Medical Journal (BMJ) reported that FDA's Peripheral and Central Nervous System Drugs Advisory Committee unanimously recommended approval of Eli Lilly’s monoclonal antibody donanemab to treat Alzheimer’s disease. If the agency agrees, it will join Eisai and Biogen's Leqembi (lecanemab), and Biogen’s Aduhelm (aducanumab), which has been withdrawn, as the only drugs approved to treat Alzheimer’s in the US.

After giving Eli Lilly's cancer drug Retevmo (selpercatinib) accelerated approval in 2020 to treat patients 12 and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, the FDA this week announced it has granted the drug traditional approval and has expanded the indication to patients as young as two. The drug was also granted breakthrough designation and orphan drug designation and was submitted under the agency's voluntary Assessment Aid program.

French drugmaker Ipsen announced that FDA has granted accelerated approval for its drug Iqirvo (elafibranor) to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). The drug is currently only for patients who don't respond well to UDCA or can't tolerate UDCA.

Medtech

FDA published a web page to explain why there have been several safety recalls for over-the-counter eye drops over the past months, how the agency regulates the products, and how it monitors their manufacturing. It noted that consumers should not use OTC eye drops intended to treat serious eye conditions, homeopathic eye drops, and those that contain ingredients such as silver sulfate and methylsulfonylmethane (MSM).

Medline Industries has initiated a class I recall for its Sub-G Endotracheal Tube with Subglottic Suction, which is used to keep patients' airways open, drain fluids, clear blockages, and generally help them breathe. The FDA said the company has received reports that certain components of the product could detach or tear, leading to airway obstruction, resulting in a lack of oxygen and potentially death.

Megadyne has issued a class I recall for its Mega Soft Pediatric Patient Return Electrode, which is used to heat, cut, or stop bleeding in small children during electrosurgery. The FDA said the company has received four reports of children inadvertently burned by the device during surgery, and it could cause third-degree burns, scarring, and the need for additional surgery.

Swedish MedTech manufacturer Getinge has issued a class I recall for its Vaporizer Sevoflurane Maquet Filling, part of its Flow anesthesia systems used to mix liquid Sevoflurane with oxygen during an anesthetic procedure. FDA said the company has received reports of discoloration and corrosion inside the vaporizer after the product was used with low-water content sevoflurane manufactured by Piramal or Baxter, and warned it could degrade to become hydrogen fluoride, a toxic acid, that may cause serious injury or death.

Teleflex and its subsidiary Arrow International issued a class I recall for their Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits used during cardiac and non-cardiac surgery to treat patients with acute coronary syndrome or complications from heart failure. FDA said a manufacturing error could cause the catheter's balloon to be overtwisted that could prevent it from fully inflating ultimately leading to lack of blood flow to the patient and potentially death.

This Week at FDA: SCOTUS throws out mifepristone case, House subcommittee passes FDA budget

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