This Week at FDA: Inspection backlog, tampon safety, 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, the Associated Press reported FDA is struggling to complete a backlog of drug facility inspections, and the agency said it will investigate reports of toxic metals in tampons after being pressed on the issue by Democratic lawmakers.

During the COVID-19 pandemic, FDA struggled with a growing backlog of inspections as investigators could not inspect manufacturing facilities in person and often had to rely on alternate tools, such as remote regulatory assessments. Despite the agency’s effort to ramp up inspections, the Associated Press (AP) reported this week that the agency is still struggling to catch up with inspections of about 2,000 drug manufacturing facilities in the US and more than 340 in India and China.

An analysis by AP found that more than two-fifths of facilities currently registered to manufacture drugs in the US were last reviewed by FDA before May 2019. The agency's guidelines make it mandatory to inspect facilities that have not been reviewed in the past five years, and it did not give an update on when it expects to catch up on the backlog of inspections.

NPR reported that US Democratic lawmakers are calling on FDA to address concerns about toxic metals found in tampons. Researchers published a study this summer that found arsenic and lead in more than a dozen popular tampons used in the US that could cause cardiovascular, neurological, liver, and kidney damage and increase risk for dementia and cancer.

Sen. Patty Murray (D-WA), chair of the Senate Appropriations Committee, said FDA has responded to the lawmakers' request. She said the agency has initiated an independent literature review, and an internal lab is studying the issue.

The medtech lobby group AdvaMed this week announced it has been accredited by the American National Standards Institute (ANSI) to develop industry standards for medical devices. The group said it will begin by developing standards for imaging devices in areas such as artificial intelligence (AI) and cybersecurity.

Drugs & Biologics

The Center for Biologics Evaluation and Research has published its updated standard operating policy and procedures (SOPP) for why and when staff may issue a refuse to file (RTF) decision on a biologics license application (BLA), an efficacy supplement or a prior approval manufacturing supplement, or a new drug application (NDA) or supplemental NDA. The updates include examples of where the agency may issue an RTF and certain technical updates.

External experts of the Cardiovascular and Renal Drugs Advisory Committee are scheduled to meet 10 October to discuss Stealth BioTherapeutics' elamipretide hydrochloride injections to treat Barth syndrome, a rare heart disease. The company said the drug has fast track and orphan drug designation from FDA, and a PDUFA decision date is set for early 2025.

Novartis' supplemental biologics license application (sBLA) to update the risk evaluation and mitigation strategy (REMS) for its CAR-T cell cancer drug Kymriah (tisagenlecleucel) was approved by FDA. The company asked to change the layout of the Kymriah REMS website landing page.

Pfizer's sBLA to update the package insert for its respiratory syncytial virus (RSV) vaccine Abrysvo (RSV vaccine) was approved by FDA. The update includes safety and efficacy information from the end of the first season based on a recent study of the vaccine and how it performed with the seasonal inactivated influenza vaccine in another study.

Emergent's sBLA for its ACAM2000 smallpox vaccine to also inoculate against the mpox virus was approved by FDA. The agency notes the decision to expand the indication was based on a nonclinical study that tested the vaccine on non-human primates.

GlaxoSmithKline' sBLA to update the label for its meningococcal disease vaccine Menveo (neisseria meningitidis serogroups A, C, Y, and W) was approved by FDA. The label will include new information such as the updated end of shelf-life (EoSL) acceptance criteria of the vaccine and correct certain protein information.

Medtech

Gale Force Aesthetics' Illuminate PRP platelet preparation system, which prepares autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient's point of care, has been cleared by FDA. The device uses centrifugal force to separate plasma from the blood.

FDA is hosting a webinar on 24 October on its total product life cycle (TPLC) oversight of in vitro diagnostics (IVD). Stakeholders can email the agency their questions for the webinar by 23 September.

FDA announced this week it is classifying several products as class II products with special controls. They include hydrophilic re-coating solutions used on contact lenses; blood collection devices for cell-free nucleic acids used to collect, store, transport, and handle blood specimens; endoscopic pancreatic debridement devices intended to remove necrotic tissue from a walled-off pancreatic necrosis (WOPN) cavity; open loop fluid therapy recommenders to be used as adjunctive diagnostics to analyze cardiovascular vital signs and predict a patient's estimated response to fluid therapy; radiofrequency toothbrushes; heparin and direct oral factor Xa inhibitor drug test systems; and hemodialyzer devices with expanded solute removal profile to be used as part of an artificial kidney system to treat patients with renal failure.

Medtronic has issued a class I recall for its McGrath MAC Video Laryngoscopes after receiving reports that the batteries on the devices may drop below their designed threshold, causing them to overheat and possibly explode, according to FDA. The company said consumers should stop using older versions of the devices, but for newer versions, users can follow the updated instructions, which include instructions on proper handling and disposal of the batteries.

Abbott has issued a class I recall for FreeStyle Libre 3 continuous glucose monitoring (CGM) sensors after reports that they were giving glucose readings that were too high, according to FDA. The company said users should stop using the devices suspected of having faulty sensors and throw them away.

Breas Medical has issued a class I recall for its Vivo 45 LS ventilators after the company's tests found that patients using the devices for the first time may experience a short-term increase in formaldehyde exposure, which could cause irritation or inflammation of the airways, according to FDA. The company has sent updated instructions to users to only use the ventilator at a maximum room temperature of 30 Celsius and pre-run certain devices.

FDA has published its quarterly update on its Global Unique Device Identification Database, which includes data until 28 August. The latest data shows a continued steady increase in the number of devices added to the database, including an overwhelming number of devices for orthopedics, dental, and general and plastic surgery.

FDA updated the list of augmented reality and virtual reality (AR/VR) medical devices that it has allowed on the market. So far, the agency has authorized 69 such devices, six of which were authorized this year.

This Week at FDA: Inspection backlog, tampon safety, and more

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