This Week at FDA: Dueling mifepristone rulings, CBER head makes executive decision, 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. We’ve been following the tumult surrounding the dueling rulings by US district judges over mifepristone, which could have major implications for FDA’s regulatory authority.

Late last Friday, US District Judge Matthew Kacsmaryk, of the Northern District of Texas, ruled against FDA in Alliance for Hippocratic Medicine v. FDA, staying the agency’s approval of mifepristone granted more than two decades prior. His ruling gave the administration 7 days to appeal before it would enter effect.

Nearly immediately after, US District Judge Thomas Rice, of the Eastern District of Washington, issued a competing ruling ordering FDA to not to alter the status quo for mifepristone in 17 states and the District of Columbia. The Texas court ruling was quickly appealed to the Fifth Circuit Court of Appeals, which stayed part of Kacsmaryk’s ruling, but allowed parts that would roll back some of FDA’s more recent moves to facilitate access to medication abortion via the drug. On Thursday, the Department of Justice sought emergency relief from the Supreme Court. While the matter remains in legal limbo, Reuters reports that some providers have already started limiting access to the drug.

The ruling has raised questions about FDA’s authority to regulate medical products and has produced multiple takes on how the agency could respond to an unfavorable ruling, including some calls for the agency to simply ignore it by exercising its enforcement discretion, though the White House has pushed back on this as a possibility.

Hundreds of drugmakers have voiced their support of FDA in the case, Reuters reports, and Jim Stansel, general counsel for the lobby group PhRMA, wrote a blog post on Wednesday arguing that “FDA should remain the authority on the safety and effectiveness of medicines.”

We also learned that FDA staff were leaning toward rejecting Sarepta’s gene therapy for Duchenne muscular dystrophy before Center for Biologics Evaluation and Research (CBER) Director Peter Marks stepped in to request an advisory committee meeting to review the drug, according to a report from STAT+ (paywall). Marks also reportedly intervened to allow the company to submit the drug for accelerated approval over his staff’s finding that the application was deficient.

Following the recent economic downturn, BioPharma Dive reported this week that drugmakers have laid off more than 5,000 employees since the start of the year. The news comes as Pear Therapeutics, a digital health company, announced it has filed for bankruptcy protection under Chapter 11.

Medtech giant Medtronic is laying off 59 workers amid the closure of its Silicon Valley-area facility. The cost-cutting measure came as the company saw its sales slip in the first two fiscal quarters of last year before finally leveling out in the third quarter.

Drugs & Biologics

This week, FDA issued draft guidance detailing its expectations for the format and content of over-the-counter monograph order requests (OMORs), a key component of the recent OTC monograph reforms under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

FDA also announced it will convene advisory committees to review Pfizer’s biological license application (BLA) for its respiratory syncytial virus (RSV) vaccine Abrysvo to prevent the disease in infants up to 6 months of age by immunizing pregnant individuals and whether Eisai’s Alzheimer’s drug Leqembi (lecanemab) should receive standard approval after it was granted accelerated approval last year.

Following a proposed order issued in October 2021, FDA will move forward with exempting certain categories of biological products from the CARES Act shortage reporting requirements. The two categories of products the agency is exempting are blood and blood components for transfusion, as well as cell and gene therapy products, where a single lot treats one patient.

The agency will also hold a meeting in June on the financial transparency and efficiency of its prescription drug, biosimilar, and generic drug user fee programs, as well as a public workshop the same month on its Rare Disease Endpoint Advancement Pilot Program.

Reuters reports that FDA has halted enrollment in Merck KGaA’s clinical trial for its multiple sclerosis drug evobrutinib.

Medtech

FDA took Dutch device-maker Philips to task again for its recall of certain ventilators, bi-level positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. The agency said the number of replacement and remediated devices that have been shipped to consumers in the US is considerably less than the 2,460,000 number of "new replacement devices and repair kits" posted on Philips' website. The agency said that number includes manufactured repair kits that the company has shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers.

"We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device," said FDA. "We encourage consumers to contact Philips to get an update on the status of their replacement device."

In response, Philips issued a statement that 2.2 million devices it has repaired or replaced have actually been sent to patients in the US.

FDA has updated information about Abbott's recall of FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems’ reader devices that are at risk of catching fire from their lithium-ion batteries if not properly maintained. The agency notes that users who are not experiencing problems with their product, and are using the USB cable and power adapter provided by Abbott can continue to use the product.

FDA also published a number of medical device guidances this week including a final guidance on non-clinical testing, animal studies and clinical studies, and labeling for peripheral percutaneous transluminal angioplasty (PTA) balloon and specialty catheters premarket applications. The agency notes it does not apply to combination products that include PTA catheters.

This Week at FDA: Dueling mifepristone rulings, CBER head makes executive decision, and more

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