An uptick in most significant level of device recalls

Jun 07, 2024

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Driving The Day

A computer-run, modular device that customizes drug infusions for individual patients is seen inside a patient’s room in the Covid-19 Intensive Care Unit at a medical center.

The number of medical devices recalled for serious reasons increased last year. | Elaine Thompson/AP

2023 SPIKED — The number of the most serious medical device recalls classified by the FDA jumped last year, a development the agency’s top device regulator partly attributes to an increase in inspections.

The number of Class I recalls in 2023 was 102, an increase from the previous year’s 65 and a recent low of 45 in 2020, according to FDA data.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, told POLITICO that the agency is “not drawing a lot of conclusions” from the recall increase.

“That increase in 2023, we’ve been looking into it,” Shuren said. “Clearly, some of it can be explained by a small number of companies where we went in, did inspections, found that there were issues they should have reported as recalls. And then they had to report them all.”

The Advanced Medical Technology Association, the largest medical device trade association, did not comment on the increase.

Not all recalls are the same: Even among Class I recalls, the underlying issues vary, and an increase can result from a number of reasons, according to Madris Kinard, the founder of adverse event tracker Device Events and a former FDA public health analyst.

“It could be device issues being walked more slowly because they were critical during the pandemic or software updates that couldn’t be fulfilled,” Kinard said.

The other major consideration is that the number of recalls can’t always indicate how many devices were impacted.

“Is it eight devices, is it 800,000 devices, just going by the number of recalls doesn’t necessarily show you how serious the impact would be on the industry, or to hospitals or to other companies that are trying to come into the market.”

The bigger picture: The number of overall device recalls is decreasing, according to Shuren. He noted that more devices are coming onto the market; there are about 257,000 different types of medical technologies.

“We don’t see a red flag at the moment,” Shuren said.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. A friend is adding laser tag to his celebration of 30 years on this floating rock. What throwback activities have you recently enjoyed?

Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

A message from CVS Health:

CVS Caremark is driving biosimilar adoption and reducing costs. Our health plan sponsors, like employers, have already saved more than $315 million, and many patients now have a $0 co-pay. In the first three weeks of April, we dispensed more biosimilars than the entire market combined in 2023. We are redesigning the pharmaceutical landscape to help clients and members realize savings by increasing biosimilar adoption. Learn more.

BIRD FLU

Cage-free chickens walk in a fenced pasture at an organic farm.

A novel version of bird flu has infected poultry in Mexico. | Charlie Neibergall/AP

A FATAL CASE — A day after the World Health Organization reported a fatal case of the first laboratory-confirmed human H5N2 avian influenza infection in Mexico on Wednesday, health officials at a WHO webinar said that while the source of the exposure to the virus is unknown, H5N2 viruses have been found in poultry in Mexico.

The individual had developed fever, shortness of breath, nausea and other symptoms on April 17. On April 24, they sought medical attention and passed away the same day.

The development is worrisome because this version of the virus hasn’t been seen before and how the person who died was infected is unknown, Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health, said.

“This individual was clearly quite sick prior to infection, so what this means for the general public, we can’t say,” Nuzzo said. “But we also can’t just throw away our concern based on the fact that the individual may have been at high risk for severe illness.”

In the U.S.: The version of the virus found in the Mexico case is different from the H5N1 bird flu strain circulating among dairy cows in the U.S.

CDC updated its technical report on avian influenza Wednesday with additional details of recent U.S. cases and a case in Australia.

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Eye on the FDA

DONANEMAB MEETING ON DECK — A long-awaited advisory committee for Eli Lilly’s Alzheimer's disease drug donanemab will be tasked Monday with voting on whether the medication is effective and whether its benefits outweigh its risks for those with mild cognitive impairment and dementia.

Notably, the agency’s questions for the panel focus on the population studied in clinical trials for the drug. Read the FDA’s briefing document, Eli Lilly’s briefing document and the voting questions for the expert panel.

Tobacco

JUUL GETS ANOTHER SHOT — The FDA said Thursday it is pulling back marketing denial orders issued to Juul in June 2022, a development that potentially opens the door to a marketing authorization for the Juul device and some pods.

“Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied,” the FDA said. “Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA.”

Why now: The agency said it made the move partly because of new case law from litigation involving other manufacturers and its review of information from Juul.

“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health,” Juul Labs said in a statement.

“These products (the JUUL device and Virginia Tobacco and Menthol JUULpods in 5.0% and 3.0% nicotine concentration) will remain on the market during this review,” the company added.

A message from CVS Health:

Pharma Worldwide

DUTCH PANEL RECOMMENDS MDMA — Days after the FDA’s outside advisers said that the psychedelic drug MDMA is not an effective treatment for post-traumatic stress disorder, a Dutch state commission recommended the therapy, POLITICO’s Mari Eccles reports.

The FDA’s outside expert panel voted 9-2 earlier this week that Lykos Therapeutics’ combo regimen of talk therapy and MDMA is not effective and 10-1 that the treatment’s risks outweigh its benefits, POLITICO’s Erin Schumaker reports.

JOIN US ON 6/13 FOR A TALK ON THE FUTURE OF HEALTH CARE: As Congress and the White House work to strengthen health care affordability and access, innovative technologies and treatments are increasingly important for patient health and lower costs. What barriers are appearing as new tech emerges? Is the Medicare payment process keeping up with new technologies and procedures? Join us on June 13 as POLITICO convenes a panel of lawmakers, officials and experts to discuss what policy solutions could expand access to innovative therapies and tech. REGISTER HERE.

WHAT WE'RE READING

Walmart closed its health care clinics after losses reached $230 million last year, Endpoints News’ Shelby Livingston reports.

Document Drawer

Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) issued a request for feedback on the future of Cures 2.0 legislation. The bill has not yet been reintroduced this Congress.

The Government Accountability Office released a report on over-the-counter hearing aids.

A message from CVS Health:

CVS Caremark is moving the market to lower cost alternatives, and our bold biosimilar strategy continues to deliver savings without compromising care. Our health plan sponsors, like employers, have already saved more than $315 million, and many patients now have a $0 co-pay. In the first three weeks of April, we dispensed more biosimilars than the entire market combined in 2023.

Learn more about how CVS Health is supporting clients, patients, and providers through this formulary change and innovations to come. Learn more.