This Week at FDA: QMSR final rule, Dems defend FDA’s mifepristone approval, 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 released a much-anticipated final rule reforming its quality system (QS) regulation and issued several guidances. Plus, Democratic lawmakers came to defend the agency’s approval authority in a case involving the abortion drug mifepristone.

The biggest news of the week is that FDA has finally published its Quality Management System Regulation (QMSR) final rule that incorporates the International Organization for Standardization (ISO) standard ISO 13485:2016 into its Quality System (QS) regulation. The agency heeded industry concerns and has given manufacturers two years to come into compliance, instead of one year as was originally proposed.

This week, 263 congressional Democrats, including leading lawmakers in the House Energy and Commerce (E&C) and the Senate Health, Energy, Labor, and Pensions (HELP) committees, filed an amicus brief urging the Supreme Court to reverse a stay from a Texas district court judge in a case that could curtail FDA's ability to allow the abortion drug mifepristone to be marketed. The lawmakers warn that the case could have greater implications than mifepristone and could ultimately undermine FDA's ability to review the safety and efficacy of medical products.

The Biden administration sent out its initial offers to drug manufacturers that manufacture 10 prescription drugs that are participating in its Medicare Drug Price Negotiation Program under the 2022 Inflation Reduction Act. On the same day, the Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released several reports that detail how prescription drugs in the United States compare in price to drugs in other Organization for Economic Co-operation and Development (OECD) countries.

The Government Accountability Office (GAO) published a report this week on how some agencies can prepare for artificial intelligence/ machine learning (AI/ML) and other technologies. The agency noted that FDA wants updated authorities to regulate AI/ML from Congress but hasn't provided any concrete legislative asks. It said the FDA should identify the statutory authorities it needs and ask Congress for them.

FDA published several guidances this week, including guidances on genome editing, chimeric antigen receptor (CAR) T cell products, and a long-awaited draft guidance on collecting race and ethnicity data in clinical trials.

Drugs & Biologics

FDA published its Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap, updating its January 2023 draft roadmap that outlines its biosimilar regulatory science research pilot program research priorities. After stakeholder feedback, the agency says the updated document provides more clarity and context on setting research priorities.

The Center for Biologics Evaluation and Research (CBER) has published a list of guidance topics it will consider developing in the current calendar year. The center notes that the list not only includes level 1 draft guidances that it is considering finalizing but also guidances that may need to be updated and topics that are not currently covered under guidance.

FDA said its Oncologic Drugs Advisory Committee (ODAC) will meet on 14 March to discuss Geron's new drug application (NDA) for imetelstat, a first-in-class telomerase inhibitor. The injection is intended to treat transfusion-dependent anemia in adults with low- to intermediate-risk myelodysplastic syndromes who are not responding to or are ineligible for erythropoiesis-stimulating agents.

ODAC is also set to meet the following day on 15 March to consider Janssen's supplemental biologics license application (sBLA) for its intravenous infusion Carvykti (ciltacabtagene autoleucel). The drug is intended to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are resistant to lenalidomide.

Endpoints News reported that according to a Form 483 it obtained through a FOIA request from FDA, the agency found five major deficiencies during an inspection of Eli Lilly's Indiana corporate offices in September regarding its schizophrenia drug Zyprexa Relprevv (olanzapine). The agency said the company had shipped the drug to uncertified pharmacies, and failed to follow its approved Risk Evaluation and Mitigation Strategy (REMS) program.

FDA warned consumers not to use South Moon, Rebright, or FivFivGo eye drops, which are copycat products of Bausch + Lomb’s Lumify over-the-counter brand eye drops approved for redness relief. The agency said it bought the copycat products online to test them and found some of them were contaminated with Burkholderia cepacia complex, which may cause eye infections.

Medtech

The Center for Devices and Radiological Health (CDRH) announced that as of 1 February it has enrolled 31 medical devices into its Total Product Life Cycle (TPLC) Advisory Program (TAP) pilot. The center had initially asked the industry to fully fund the TAP program under the Medical Device User Fee Amendment (MDUFA V) deal but ultimately settled on launching a pilot program to assess its feasibility in helping sponsors engage external stakeholders such as payors earlier.

Reuters reported that Philips has agreed to a consent decree with FDA not to sell new devices to treat sleep apnea in the US in the coming years. Details of the settlement have not been made public yet but comes after millions of continuous positive airway pressure (CPAP) machines and ventilators were recalled in 2021 after it was found that foam in the machine could degrade and potentially cause cancer and other health issues. FDA declined to comment as the settlement is being finalized.

Simultaneously, FDA provided an update on medical device reports (MDRs) it has received regarding breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in Philips Respironics ventilators, their bilevel positive airway pressure (BiPAP) machines and CPAP machines between July 2023 and 30 September 2023. The agency noted that within that timespan it has received more than 7,000 MDRs on the issue and recorded 111 deaths.

The FDA reminded stakeholders that it is holding a third virtual town hall on 7 February to discuss its expectations regarding medical device sterilization in premarket submissions submitted by sponsors. The agency has been holding these discussions as part of its efforts to help reduce industry's dependence on ethylene oxide (ETO), which the Environmental Protection Agency has been developing rules around to reduce its use due to its potential risk for cancer.

FDA warned healthcare providers not to use certain Cardinal Health Monoject luer-lock and enteral syringes used to deliver fluid, feeding, or medications to a patient’s feeding tube. The agency said newer syringes have different dimensions than what was originally meant for marketed and may cause compatibility issues with syringe pumps, patient-controlled analgesia (PCA) pumps, or enteral syringe pumps, which may lead to overdosing, underdosing, delay in therapy, delay in occlusion alarms, and delay in feeding.

This Week at FDA: QMSR final rule, Dems defend FDA’s mifepristone approval, and more

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