This Week at FDA: QMSR is upon us, FDA transparency, 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, we finally laid eyes on FDA’s proposal to overhaul its medical device quality system regulation, read up on a survey on FDA transparency, and saw FDA update two EUAs for COVID-19 drugs.

Leading the news this week was FDA’s long-awaited proposed rule to align its Quality System Regulation with the international standard ISO 13485. The resulting regulation will be known as the Quality Management System Regulation (QMSR), and FDA is proposing a one-year transition period for device makers from the date the regulation is finalized.

The Department of Health and Human Services (HHS) issued a report this week detailing progress made toward strengthening the US medical supply chain during the COVID-19 pandemic.

We also took a look at this research letter in JAMA Network Open on FDA transparency. The letter was based on a survey of more than 1000 participants that found, by and large, that most respondents favored transparency measures. “Support for all transparency measures was high. Specifically, 86.2% of participants supported the disclosure of the reasons medications are not approved, 66.7% supported the release of basic information about medications in development, 77.6% supported the disclosure of the reasons clinical studies are placed on hold, and 77.2% supported the disclosure of the reasons studies are permitted to resume,” the authors found.

Drugs and biologics

This week, FDA revised the emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) to double the initial dose of both substances from 150 mg to 300 mg. Subsequent doses will remain at the 150 mg amount, and FDA said that patients who have already received the 150 mg initial dose should get an additional dose “as soon as possible to raise their monoclonal antibody level to those expected for patients receiving the higher dose.”

FDA also moved to limit the use of GlaxoSmithKline and Vir’s COVID-19 antibody sotrovimab in areas where the circulating variants have high levels or resistance to the drug.

Boehringer Ingelheim’s Jardiance (empagliflozin) will be available to more patients to treat heart failure, following its latest approval this week. Jardiance was initially approved to help control glucose in adults with type 2 diabetes and has since been approved to reduce risk of hospitalization and death in heart failure patients with low ejection fraction.

After being sued by several compounding pharmacies and being remanded in court, FDA said it considers its memorandum of understanding (MOU) with states regarding limits on the amount of compounded drugs that can be distributed interstate to be suspended. FDA said it will no longer enter into new agreements with states, nor does it expect states that already signed to comply with the agreement. FDA will instead go through the notice-and-comment rulemaking process before finalizing the MOU.

Medical devices

While the QMSR proposed rule was the biggest news of the week, there was plenty of other news related to medical devices.

Earlier this week, FDA authorized the first condom specifically indicated to reduce the transmission of sexually transmitted infections during anal intercourse. The ONE Male Condom was classified into class II (special controls) via the de novo pathway. “The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” said Courtney Lias, director of FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices within the Center for Devices and Radiological Health.

FDA also recently published the available Patient Problem Codes associated with its legacy Alternative Summary Report (ASR) program. The codes were previously added to the agency’s MAUDE database. The ASR program was ended it June 2019 and FDA notes that reports ASR reports received between 1999 and April 2019 are not in MAUDE and can only be found on in the legacy reports listed here.

Three Class I recalls were announced in the last week.

Arrowhead International, a Teleflex subsidiary, is recalling the Arrow-Trerotola Percutaneous Thrombolytic Device due to the risk of tip damage during use. FDA said it received 35 complaints through December 2021, 14 of which reported injuries. No deaths have been reported. Two Class I recalls were announced for unauthorized COVID-19 products, E25Bio’s COVID-19 Direct Antigen Response Tests and BASE10 Genetics’ RNAstill MTM specimen collection kits. Both devices, FDA said, were distributed “without proper premarket clearance.”

Speaking of COVID-19 tests, FDA now has a webpage listing all authorized at-home over-the-counter COVID-19 tests. The current count is 14 antigen and 3 molecular tests authorized for such use.

This Week at FDA: QMSR is upon us, FDA transparency, and more

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