This Week at FDA: Final EtO rule, IMDRF meeting, and more

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, FDA hosted global medical device regulators in Washington, DC, EPA finalized a rule on ethylene oxide (EtO), and FDA released a new report on artificial intelligence/machine learning (AI/ML).

The week started with the US Food and Drug Administration (FDA) hosting the International Medical Device Regulators Forum. The first two days of the five-day meeting were open to the public and were used to discuss reliance across regulatory regimes and to update attendees on the progress made by various working groups.

The Environmental Protection Agency (EPA) finally published a much-anticipated rule restricting the use of the medical device sterilization agent ethylene oxide (EtO). FDA responded by stating it shares EPA’s goal of reducing EtO exposure to workers and communities neighboring sterilization facilities while ensuring the integrity of medical device supply chains, which it said is reflected in the final rule.

Steve Grossman at the Alliance for a Stronger FDA analyzed President Biden's $3.682B FY2025 funding request to Congress, which is $168M over what was appropriated in FY2024, a nearly 5% increase. He noted that $115M of the increase would be to pay mandatory salary increases, which means there is less in the bucket to increase funding for other areas of the agency's work.

FDA published a new report on how its medical product centers will work together to regulate AI/ML products. It details the agency's goals to promote development and use of standards to accomplish its public health mission.

The agency also launched a new webpage FDA that describes how it uses inspections to help ensure drug safety and quality. The page details its policies on current good manufacturing practice (CGMP) inspections, how it conducts compliance reviews, classifies inspections, and the tools it uses in its inspection efforts.

Several guidances were released by FDA this week, including a second revision of its draft guidance for developing drugs intended to treat early Alzheimer’s disease, one that proposes updating its final guidance on medical device cybersecurity, and another that clarifies definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs.

The agency also published a final guidance that replaces a similar 2020 guidance on how generic drugmakers can submit controlled correspondence when requesting information on generic drug development. Additionally, it published a draft guidance on its medical device submission process which allows sponsors to interact early with the agency and is intended to replace a 2023 final guidance eventually.

FDA published a draft guidance on how to test devices that produce tissue temperature changes. The agency says the guidance is meant to ensure consistency and efficient review of thermal effects of devices that have such effects that are submitted in premarket applications.

It also said it plans to publish a final guidance on pharmacokinetics in patients with impaired renal function that replaces a draft version from 2020. The agency said the guidance is meant to help sponsors design studies and analyze data to assess impaired renal function on their investigational drug's pharmacokinetics (PK) and/or pharmacodynamics (PD).

Additionally, FDA published a draft version of the International Council for Harmonisation (ICH) E2D(R1) guideline for public consultation. The guidance will replace the original E2D guideline that was adopted in 2003 and clarifies the use of data sources that are either new or increasingly used in communicating postmarket adverse events such as social media, market research programs, and patient support programs.

Drugs & Biologics

In briefing documents submitted to the Oncologic Drugs Advisory Committee (ODAC) before a 15 March meeting, FDA reviewers said they were uncertain if Janssen's Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb's Abecma (idecabtagene vicleucel), both chimeric antigen receptor (CAR) T-cell therapies, would be effective in treating patients with blood cancer. The advisory committee, however, voted unanimously that the benefits of Carvykti outweighed its risks and voted 8-3 in favor of Abecma.

Reuters reported that Eli Lilly has added Amazon.com to its direct-to-consumer service, LillyDirect, to deliver prescription drugs. According to the report, LillyDirect Pharmacy Solutions can now expect to get their prescription drugs from Amazon Pharmacy or Truepill, depending on their insurer and other factors.

Reuters also reported that FDA has expanded Bristol Myers Squibb's CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to treat chronic lymphocytic leukemia or small lymphocytic lymphoma. It was initially approved in 2022 to treat patients with recurring large B-cell lymphoma in patients or for those whose other treatments had stopped working.

FDA approved Madrigal Pharmaceuticals' Rezdiffra (resmetirom) as the first treatment for moderate to advanced liver scarring (fibrosis) due to noncirrhotic non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, in conjunction with diet and exercise. The agency noted the drug works by activating a thyroid hormone receptor, which then reduces the accumulation of fat in the liver.

Chinese drugmaker BeiGene announced FDA has approved its cancer drug Tevimbra (tislelizumab-jsgr) to treat patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. It noted that the drug had already been approved for the same indication by the European Commission in 2023 and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to treat non-small cell lung cancer in three indications.

Mirum Pharmaceuticals announced FDA had approved its oral solution Livmarli (maralixibat) to treat cholestatic pruritus due to progressive familial intrahepatic cholestasis (PFIC), itching due to a rare liver disease, in children five years and older. The company said it also submitted an additional supplemental new drug application (sNDA) for a higher concentration of the drug so it can be used for younger patients.

FDA sent a warning letter to Human Microbes for selling fecal microbiota for transplantation (FMT) on its website www.humanmicrobes.org without marketing authority from the agency.

Medtech

On 21 March, FDA will host another virtual town hall on medical device sterilization. The agency has been holding these town hall meetings to educate manufacturers about sterilization alternatives to ethylene oxide, and the focus of the upcoming meeting will be consensus standards in premarket review.

FDA published a rule amending certain medical device regulations to conform to regulatory requirements under the Food, Drug, and Cosmetics (FD&C) Act. The agency added that the rule is primarily editorial to ensure accuracy and clarity and does not impose any new requirements.

FDA sent a warning letter to Nobles Medical Technology II after its inspectors found serious good clinical practice (GCP) violations in the way it managed its Institutional Review Board (IRB), selected investigators and monitors, and got signed agreements from investigators. The agency also sent a warning letter to Exactech for failing to establish corrective and preventive actions adequately, meet current good manufacturing practices (CGMP), and maintain Medical Device Reporting (MDR) protocols.

This Week at FDA: Final EtO rule, IMDRF meeting, and more

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