This Week at FDA: Shuren pushes for LDT reform, GAO to investigate device recalls, 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, FDA’s top medical device regulator issued a joint statement with his counterpart at the Centers for Medicare and Medicaid Services (CMS), stressing the need for FDA to extend its oversight of laboratory developed tests (LDTs).

In a joint statement released on Thursday, Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, and Dora Hughes, acting chief medical officer and acting director of the Center for Clinical Standards and Quality at CMS, asserted the need to “reconsider” the agencies’ longstanding approach to regulating LDTs and championing FDA’s proposed rule to enhance its enforcement oversight of LDTs.

The two also pushed back on the suggestion that an expansion of the Clinical Laboratory Improvement Amendments (CLIA) could address concerns related to LDTs. “CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense,” Shuren and Hughes wrote.

FDA’s oversight of medical device recalls will be the subject of an upcoming investigation by the Government Accountability Office (GAO), ProPublica reports. The investigation was prompted by a request by Sens. Dick Durbin (D-IL) and Richard Blumenthal (D-CT), who wrote to GAO in December 2023 raising concerns about the increase in medical device recalls and adverse event reports over the previous decade. The senators pointed to Philips Respironics’ 2021 recall of its continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), and mechanical ventilator devices due to defective foam that could deteriorate, potentially causing headaches, vomiting, allergic reactions, or “toxic or cancer-causing effects” in patients treated with the devices. According to previous reporting by the Pittsburgh Post-Gazette and ProPublica, Philips Respironics was alerted to the issue as early as 2010, yet did not launch a formal investigation into the issue for nearly a decade.

The Hill reports that President Joe Biden on Friday signed a continuing resolution (CR) passed by both chambers of Congress the previous day that will fund the government until early March, narrowly averting a partial government shutdown this week. Specifically, the CR extends funding for FDA through 1 March 2024, giving lawmakers additional time to reach a deal on a full-year appropriations package.

According to Reuters, FDA inspectors handed Eli Lilly a Form 483 listing eight observations, following an inspection of its Branchburg, New Jersey facility in July 2023. The observations reportedly dealt with “problems in tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment.” Lilly told Reuters that most of the observations have been addressed or are currently being addressed and that the issues do not affect quality, safety, or supply of any of its products.

Drugs & biologics

FDA has added a boxed warning to Amgen’s osteoporosis drug Prolia (denosumab) label due to the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD). FDA said that the issue was more common in patients with CKD who also have mineral and bone disorder (CKD-MBD) and has resulted in hospitalizations and deaths.

On Thursday, our friends at AgencyIQ spotted that FDA quietly revised its guidance Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. The update includes minor changes from the version issued in August 2023 related to homogeneous and nonhomogeneous cases and some wording changes.

On Tuesday, FDA released a meeting report from its October workshop on mitigating clinical study disruptions during disasters and public health emergencies (PHE) Section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). The law required FDA to convene a public meeting within 180 days of the end of the COVID-19 PHE to discuss how sponsors used FDA’s COVID-19 clinical trials guidance. The report outlined how and whether sponsors followed the recommendations in the guidance.

Also on Tuesday, FDA announced it was extending the shelf-life for Emergent Biosolutions’ Narcan (naloxone hydrochloride) 4 mg nasal spray from three to four years in an effort to expand access to the overdose prevention drug.

FDA has released its latest monthly generic drugs program monthly and quarterly activities report. In November, FDA approved 51 generic drugs. Of these, four were first-time generics and six were approved in the first-cycle.

The Center for Biologics Evaluation and Research (CBER) this week posted an untitled letter to Maryam Amiri, co-founder of Hadaf LLC (dba Brillia) in Phoenix, AZ for making unapproved claims for its Brillia product. In selling its “Brillia For Children” and “Brillia For Adults” on its website, the company claims that various dilutions of Lapine S-100 immune globulin can treat diseases or conditions in humans, including attention deficit/hyperactivity disorder (ADHD), autism, and anxiety. FDA said the firm needs a valid biologics license application to make these claims.

FDA announced it is seeking applications to study the human abuse potential for botanical kratom. FDA said in the notice that it “has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited.” The application deadline is 18 March 2024.

This week, Public Citizen released a report asserting that the manufacturers of the 10 drugs selected for Medicare price negotiation under the Inflation Reduction Act spend more on executive salaries, stock buybacks, and dividends than they do on research and development. The group said that the manufacturers spent $10 billion more on these “self-enriching activities” such as stock buybacks, dividends, and executive compensation than on research and development in 2022.

Along these lines, on Thursday, Sen. Bernie Sanders (I-VT), Chairman of the Senate Committee on Health, Education, Labor, and Pensions (HELP), announced the committee will schedule a vote on 31 January on whether to issue subpoenas for Johnson & Johnson CEO Joaquin Duato and Merck CEO Robert Davis. These executives will be asked to testify why their companies charge “substantially higher prices for medicine in the U.S. compared to other countries” according to an announcement from Sanders’ office. If approved, this would be the first subpoena issued by the HELP Committee since 1981.

FDA also announced a meeting of its Medical Imaging Drugs Advisory Committee on 5 March 2024 to review Lumicell’s new drug application for pegulicianine for injection for use as the optical imaging drug constituent of a combination product developed by the company. The imaging drug is intended to help detect remaining cancerous tissue within the lumpectomy cavity following removal of the primary specimen during lumpectomy surgery.

Medtech

FDA this week published a report to Congress on its medical device pilots in FY 2022. The report, required under the FDA Reauthorization Act of 2017 (FDARA) provides an overview of the agency’s ongoing and completed pilots.

The agency also announced an upcoming meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to review the premarket approval application (PMA) for Abbott Medical’s TriClip G4 System, which is intended to treat patients with symptomatic severe tricuspid regurgitation despite undergoing medical therapy, who are at risk for surgery and for whom tricuspid valve edge-to-edge repair is appropriate.

Earlier this week, FDA issued a safety communication warning of risk associated with Exactech’s Equinoxe Shoulder System joint replacement devices made between 2004 and August 2021. FDA said the devices were packaged in defective bags that were missing an oxygen barrier layer, increasing the risk of oxidation that could cause the device to wear faster than anticipated.