This Week at FDA: PreCheck manufacturing program, new FDA chief counsel, 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 announced a PreCheck program to encourage domestic drug manufacturing, the agency named its new chief counsel, and HHS ended several mRNA projects.

FDA announced the launch of its FDA PreCheck program, which is intended to increase regulatory predictability and encourage companies to build manufacturing facilities in the US. The program is in response to President Donald Trump's Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines," which directed the agency to streamline review of domestic drug manufacturing and cut unnecessary regulatory requirements.

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary in a statement. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”

The program includes a facility readiness phase that allows more frequent communications between FDA and manufacturers during critical drug development stages and an application submission phase that streamlines the chemistry, manufacturing, and controls (CMC) part of premarket applications by facilitating pre-application meetings and allowing early feedback.

Sean Keveney was appointed FDA chief counsel after serving as acting general counsel at HHS, where he led the Trump administration's charge that universities such as Harvard, Columbia, Brown, and Duke had discriminated against Jewish students and women and withheld government funding for the institutions. The agency also announced that Robert Foster, HHS principal deputy general counsel, will take over as HHS acting general counsel.

The Department of Health and Human Services announced that it is ending mRNA vaccine development projects conducted by the Biomedical Advanced Research and Development Authority (BARDA) after a comprehensive review that were started during the COVID-19 pandemic. HHS Secretary Robert Kennedy, Jr., who has been critical of mRNA vaccines, said BARDA is terminating 22 mRNA vaccine projects “because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”

Several experts have criticized the move. Bobby Mukkamala, president of the American Medical Association (AMA), noted that vaccines saved lives during the pandemic and told STAT News that the administration should reconsider its decision.

STAT News reported that, according to sources, it was Richard Pazdur, director of the FDA’s Oncology Center of Excellence, and his team that insisted the FDA reject Replimune Group's skin cancer RP1 due to lack of efficacy, and not Vinay Prasad, former director of the Center for Biologics Evaluation and Research (CBER). Prasad was recently pushed out from FDA after conservative commentators criticized him for several decisions, including the agency's rejection of RP1.

The Federal Trade Commission (FTC) moved to block Edwards Lifesciences from acquiring JenaValve Technology, arguing it would reduce competition in the transcatheter aortic valve replacement devices space to treat patients with aortic regurgitation (TAVR-AR). The agency said Edwards already acquired JC Medical in July 2024, and acquiring JenaValve could allow it to dominate the market and increase costs, limiting patient access to the devices.

The New York Times reported that former FDA Commissioner and Biden administration advisor, David Kessler, has come out in support of Health and Human Services Secretary Robert Kennedy Jr.'s efforts to regulate ultraprocessed foods. It notes that Kessler has filed a citizen petition in which he argues FDA has the legal authority backed with scientific evidence to state that certain ultraprocessed foods, including certain sweeteners and refined flours, “generally recognized as safe.”

Drugs & Biologics

As China tackles an epidemic of the mosquito-borne Chikungunya virus, FDA announced it is lifting a pause on Valneva Austria GmbH's Ixchiq (Chikungunya live) vaccine for people 60 years and older. The agency paused the use of the vaccine for older patients in May to investigate serious adverse events. It has concluded the investigation and asked the company to update its label.

The Center for Drug Evaluation and Research (CDER) published its annual Report on the State of Pharmaceutical Quality, which includes some notable findings. For example, the FDA conducted 989 drug quality assurance inspections in FY 2024, a 27% increase from FY 2023, and CDER’s Product Catalog at the end of FY 2024 included 63 biosimilar products, which was a 47% increase from FY 2023.

Jazz Pharmaceuticals' cancer drug Modeyso (dordaviprone) was granted accelerated approval to treat patients over the age of one with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. The agency noted that it was the first time it had approved a drug for H3 K27M-mutant diffuse midline glioma.

CDER said it has successfully used nuclear magnetic resonance (NMR) as a new diagnostic tool to investigate molecular microstructure or Q3 properties in oil-in-water nanoemulsion formulation development. The agency said the technique may save drugmakers resources when evaluating their products and accelerate generic drug development.

FDA announced that the shortage of sodium chloride 0.9% intravenous (IV) saline products has been resolved. Makary issued a statement crediting the agency's collaboration with the Administration for Strategic Preparedness and Response and manufacturers.

Pink Sheet reported that FDA has not included funding to hire additional staff in its drug and biosimilar user fees despite the increasing workload faced by its staff. While the agency published a federal register notice stating that it expects more new drug applications (NDAs), manufacturing supplements, and investigational new drug applications (INDs) in FY 2026, compared to FY 2024, it did not ask for more funding to accommodate staffing level changes.

Medtech

FDA published a website with information on how per- and polyfluoroalkyl substances (PFAS) are used in medical devices. Also known as forever chemicals, PFAS have been associated with several ill health effects, including various cancers; however, FDA stressed that the PFAS substances used in medical devices are different from the smaller molecules that have raised health concerns in other areas. Instead, FDA said the fluoropolymers used in medical devices are typically too large to cross through cell membranes and are unlikely to cause toxicity.

FDA issued early warnings for two Boston Scientific products. The agency said the company has received reports that certain Endotak Reliance defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils are at risk of calcification, which may encapsulate and electrically insulate the defibrillation lead coils and require replacement sooner than anticipated.

FDA also noted that certain Watchman Access Systems made by Boston Scientific may increase the likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. The agency noted that patients who undergo percutaneous procedures that require transseptal access to the left atrium when conscious or deep sedation is used are three times as likely to experience negative left atrium pressure and air ingress.

This Week at FDA: PreCheck manufacturing program, new FDA chief counsel, and more

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