This Week at FDA: More RFK vaccine worries; CDER launches RWE/RWD center

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 New York Times reported that an associate of Robert Kennedy Jr. in 2022 petitioned FDA to revoke its approval of poliovirus vaccines, the agency launched a center dedicated to real-world data (RWD) and real-world evidence (RWE), and FDA Commissioner Robert Califf penned an op-ed on its work to combat opioid use disorder.

The New York Times reported that Aaron Siri, an attorney who has been helping Robert Kennedy Jr. select federal health officials for the incoming Trump administration, has a history of petitioning FDA to revoke approval of various vaccines, including vaccines against poliovirus. RFK Jr., a known vaccine critic and President-elect Donald Trump's nominee to lead the Department of Health and Human Services (HHS), has said he doesn't want to take away access to any vaccines.

The Center for Drug Evaluation and Research (CDER) announced it is launching the Center for Real-World Evidence Innovation (CCRI) to promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making. The agency said the center will provide consistency and transparency regarding decisions related to RWE/RWD across the center.

FDA Commissioner Robert Califf and Marta Sokolowska, deputy center director for substance use and behavioral Health at CDER, penned an op-ed in MedPage Today about FDA's Prescribe with Confidence campaign, which aims to educate physicians about using medications to treat patients with opioid use disorder (OUD). The campaign was launched in May and provides resources and training to help physicians treat patients with the disorder.

In a Q&A blog post, FDA Chief Medical Officer Hilary Marston and Director of the Office of Clinical Policy Ann Meeker-O'Connell discussed the agency's recent work to help update the Declaration of Helsinki in October. The Declaration of Helsinki details ethical clinical research requirements developed by the World Medical Association. While FDA was not part of writing the update, Marston and Meeker-O'Connell noted that the agency provided its perspective on vulnerable populations, research integrity, and rigorous trial design.

FDA's Science Board has been renewed until 26 June 2026. The advisory committee consists of 21 external voting members who advise the commissioner and other agency officials on complex scientific issues related to topics including food science, pharmacology, translational and clinical medicine, toxicology, biostatistics, and more.

Drugs & Biologics

FDA finalized a guidance for sponsors submitting applications for drugs intended to treat noncirrhotic nonalcoholic steatohepatitis (NASH). The nomenclature for NASH was updated in 2023 to metabolic dysfunction-associated steatohepatitis (MASH), however, while the terms are interchangeable, the agency continues to use the term NASH until MASH becomes more widely used.

On 19 February, FDA will host a public webinar to explain how its Office of Blood Research and Review (OBRR) reviews biologics license applications (BLA) for blood and blood components, including source plasma. In addition to explaining its submission and review process for such BLAs, the agency intends to detail its regulatory requirements, its pre-license and pre-approval inspection process, and address commonly asked questions.

FDA has published its updated list as of November 2024 of all user fee billable biologic products and potencies approved by the Center for Biologics Evaluation and Research under the Prescription Drug User Fee Amendments (PDUFA VII). The agency noted that there are certain circumstances where products are licensed but are not marketed or assessed user fees. Those products are listed on CBER's Discontinued List.

FDA issued a drug safety communication for Ocaliva (obeticholic acid) made by Intercept Pharmaceuticals and recommended frequent liver test monitoring of patients on the drug. The agency said its review of postmarket clinical trial data has identified cases of serious liver injury in patients without cirrhosis who were treated with Ocaliva for primary biliary cholangitis (PBC). Previously, PBC patients with advanced cirrhosis were found to be at risk of serious liver injury when taking Ocaliva.

Medtech

The Office of Science and Engineering Laboratories (OSEL) at the FDA Center for Device and Radiological Health (CDRH) has opened its 2025 summer research program for college students interested in STEM (science, technology, engineering, or math). The agency noted it has several unpaid and paid opportunities for students who want to learn about regulatory science and participate in the agency's medical device research projects.

As part of its ongoing recall for the VasoView HemoPro 2 Endoscopic Vessel Harvesting (EVH) System (VH-4000 and VH-4001), FDA noted that Getinge/Maquet has issued another urgent medical device correction notice that addresses complaints the company has received about the products. It alerted users that there have been reports of bent or detached heater wires and silicone peeling or detaching from the harvesting tool's jaws.

FDA issued an early alert for certain Fresnius Kabi Ivenix large-volume pumps after it found that some of the pneumatic valves in the infusion pumps have an increased chance of setting off non-recoverable pump problem alarms. The agency noted that the company had sent letters to customers stating that affected products need to be removed from use and repaired.

LabCorp's nAbCyte Anti-AAVRh74var HB-FE Assay, which diagnoses moderate or severe hemophilia B, was approved by the FDA in April. The agency recently published a notice detailing its reasoning for the approval and noted that physicians can use the test to identify patients with the disease who may benefit from Pfizer's virus-based hemophilia B gene therapy Beqvez (fidanacogene elaparvovec).

This Week at FDA: More RFK vaccine worries; CDER launches RWE/RWD center

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