This Week at FDA: Multiple adcomms, Louisiana lawmakers crack down on medication abortion

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 Louisiana lawmakers passed a bill to criminalize possession of certain abortion drugs, US lawmakers asked FDA to regulate lethal injections, and several of FDA’s advisory committees gave their opinion on products under review.

Republican lawmakers around the country have been on the offensive against certain drugs used for abortion in recent years, specifically targeting mifepristone and misoprostol. This week, the Louisiana House approved a bill to add the two drugs to Schedule IV of the state’s Uniform Controlled Dangerous Substances Law, according to NBC News. If signed into law, possession of the medications in the state without a valid prescription could lead to fines and jail time, though pregnant women who obtain the drugs for themselves would not be liable under the law.

Several Democratic Senators led by Sens. Elizabeth Warren (D-MA) and Cory Booker (D-NJ), wrote to the Department of Justice (DOJ) to rescind a Trump-era policy that prevents FDA from regulating drugs used for executions. In another letter, the lawmakers asked FDA and the Drug Enforcement Administration (DEA) to enforce their drug regulations for lethal injections.

In a post on FDA Law Blog, Hyman, Phelps & McNamara's Steven Gonzalez reviewed legislation introduced by Republicans in the House and Senate to stop FDA from enforcing its rule to regulate laboratory-developed tests (LDTs). While these are first steps, he notes they are unlikely to be successful in repealing the rule.

Drugs & biologics

FDA announced its approval of the first interchangeable biosimilar versions of Eylea (aflibercept) to treat macular degeneration and other eye conditions. The agency said the approvals “are based on a comprehensive review of scientific evidence demonstrating that each product is highly similar to Eylea, respectively, and that they have no clinically meaningful differences from Eylea. This evidence included comparisons of each product to Eylea on an analytical level using an extensive and robust battery of physicochemical tests and biological assays, and in a comparative clinical study in patients.”

FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee met to discuss to amendments made by Section 504 of the 2017 FDA Reauthorization Act (FDARA); the amendments required pediatric investigations of certain targeted cancer drugs with new active ingredients based on molecular target rather than clinical indications for applications submitted on or after 20 August 2020. Representatives from the European Medicines Agency (EMA), the pediatric oncology investigator community, and the pharmaceutical industry presented their perspectives.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is meeting Friday, 24 May to discuss the safety and efficacy of biologics license application (BLA) for Novo Nordisk’s long-acting insulin analog product to improve glycemic control in adults with diabetes mellitus. The panel had not yet voted by the time of publication.

FDA announced that it no longer considers the Zika virus a relevant communicable disease, and would be withdrawing its guidance on donor screening for human cell, tissue, and cellular and tissue-based product (HCT/P) establishments.

FDA announced the issuance of a priority review voucher for Pfizer’s Paxlovid tablets after determining that the product meets the criteria for a material threat medical countermeasure (MCM).

FDA announced that its Vaccines and Biological Products Advisory Committee meeting to make recommendations on the selection of the 2024-2025 formula for COVID-19 vaccines has been postponed from 16 May to 5 June.

The Center for Drug Evaluation and Research’s (CDER) Office of Communication, Division of Drug Information (DDI) hosted a webinar on fraudulent drugs.

FDA announced the availability of free training material and mentoring for health care providers who want to learn more about prescribing medications to treat opioid use disorder.

FDA also announced the availability of its FY 2023 GDUFA Science and Research report. The agency deemed eight areas as research priorities.

FDA announced that it will be hosting a public workshop on 11 July on evaluating immunosuppressive effects of drugs and biologics used in utero. The workshop will discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on developing fetuses and newborn infants.

Medtech

According to Reuters, the FDA's Medical Devices Advisory Committee's (MDAC) Molecular and Clinical Genetics Panel voted 7-2 that the benefits of Guardant Health's Shield colorectal cancer (CRC) test for those aged 45 and older outweighed its risks. While the agency is expected to make a final decision later this year, if approved, it would be the second CRC test following Epigenomics' Epi proColon test, which was approved in 2016.

FDA wants feedback on a proposed study by the Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) to understand major barriers that stop manufacturers from investing in new pediatric medical device development and what incentives may motivate them. The survey is a follow-up to the agency's August 2018 public meeting on the same topic.

FDA announced it plans to co-sponsor a two-day public workshop on using patient-generated health data (PGHD) for medical device development with the Digital Medicine Society (DiMe) on June 26. Stakeholders, including industry, regulators, and patients, are expected to discuss how such data can help promote remote clinical trial data collection and support clinical outcome assessments.

Following reports in late March of a Texas farmworker developing Highly Pathogenic Avian Influenza (HPAI) from contracting bird flu, FDA this week published a list of in vitro diagnostic tests that have FDA 510(k) clearance, have been granted de novo authorization, or have emergency use authorization (EUA) to diagnose bird flu in people. The agency noted that most of the seasonal influenza tests on its list can detect influenza A/H5N1, a subtype of influenza A. However, it was noted that only tests specifically designed for subtyping can diagnose whether someone has seasonal flu or influenza A/H5.

In the ongoing saga over faulty Chinese-made plastic syringes, FDA announced that Medline Industries and Jiangsu Shenli Medical Production have initiated recalls of unauthorized plastic syringes made in China.

Hologic has initiated a class I recall of its Biozorb Marker, an implantable radiographic marker used to mark soft tissue before surgery. FDA said there have been reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, and other complications associated with the product. So far, the agency has received 71 reports of injuries but no deaths.

Vyaire Medical has initiated a class I recall of its Twin Tube sample lines used with its Vyntus CPX system, a cardiopulmonary exercise testing device. FDA said there is concern that parts of the Twin Tube can fall apart, potentially becoming a choking hazard for the user, though there have been no reported injuries.

FDA is looking for industry nominees to serve as non-voting industry representatives on several panels of the Medical Devices Advisory Committee (MDAC). The panels include the Ear, Nose, and Throat Devices Panel; the General and Plastic Surgery Devices Panel; the Medical Devices Dispute Resolution Panel; and the Orthopaedic and Rehabilitation Devices Panel.

This Week at FDA: Multiple adcomms, Louisiana lawmakers crack down on medication abortion

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