RA/QA News Roll: Mid June 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Just a quick note that in case you’ve missed our recent FDA-specific news posts, we’ve been gathering the recent flurry of agency news in more focused newsrolls. You can view them all here.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA and the New Administration
Makary details his regulatory philosophy in JAMA 💊 — FDA Commissioner Martin Makary and Center for Biologics Evaluation and Research Director Vinay Prasad published a perspective in JAMA outlining their vision for the FDA. The article emphasizes "accelerating cures" through regulatory decisions delivered "in weeks" via pilot programs, and addresses "financial toxicity" through expediting generics and streamlining biosimilar development. The perspective recycles several existing FDA programs as "new" initiatives and notably omits discussion of medical device regulation.
HHS fires ACIP committee members 💊 — HHS Secretary Robert F. Kennedy Jr. announced that he had fired 17 members of the Centers for Disease Control and Prevention's influential Advisory Committee on Immunization Practices. He justified the move in an op-ed published in The Wall Street Journal, saying that he was "retiring" current members so he could appoint new members intended to restore public trust. Kennedy appears to want to appoint more skeptics to ACIP (and potentially VRBPAC in the future as well). Among the new appointments are former FDA advisory committee members, including Cody Meissner and Vicky Pebsworth.
O'Neill confirmed as HHS Deputy Secretary — The Senate this afternoon voted to confirm James O'Neill to be deputy secretary of HHS, a position that will provide O'Neill with significant oversight and regulatory authority over the actions of the FDA. O'Neill's extensive background on FDA-related issues suggests he could wield significant influence over agency policies.
FDA consolidation efforts advance — Commissioner Makary announced a proposed effort to "consolidate functions such as human resources, acquisitions, travel, budget, FOIA/disclosure, facilities, communications and information technology". The consolidation is intended to increase efficiencies and "eliminate duplicative services," though no final decisions have been made.
FDA staff errors lead to lawsuits — A new class-action lawsuit is challenging the use of "error-ridden" records to justify FDA staff terminations. The lawsuit claims that incorrect performance information was used to terminate employees and violated federal law. The suit also includes an allegation that DOGE representatives harassed FDA employees, with one incident involving a DOGE staff member shouting "This is DOGE and this is your Last Supper!" at an employee in a parking garage.
FDA General
AI rollout hits early obstacles — FDA Commissioner Marty Makary recently announced the launch of the FDA's "agency-wide AI tool" called Elsa — a generative artificial intelligence tool maintained within a high-security GovCloud environment. STAT News' report of all the deficiencies that FDA reviewers have already found with the agency's new tool. The tool doesn't know who the agency's leaders are. It makes mistakes about the FDA's processes. It makes incorrect assessments. According to the agency, the technology has amply demonstrated its value in enabling FDA personnel to spend less time on "tedious, repetitive tasks that often slow down the review process.” Dr Makary has directed all FDA centers to begin deployment immediately, with the goal of 'full integration' by the end of June to accelerate gen AI adoption.
Prasad outlines CBER priorities at NORD conference 💊 — Center for Biologics Evaluation and Research Director Vinay Prasad delivered a keynote address that offered industry perhaps the clearest look to date at how he plans to regulate products intended to treat rare diseases. "The FDA has a moral duty, a medical duty and a scientific duty to be fast. We are currently pioneering the fastest approaches imaginable. We are going to publish something in JAMA where we talk about just how fast we're going to get through review processes." Prasad also announced that a new guidance on Bayesian statistics is under construction.
New OTC drugs guidance released 💊 — The FDA released a draft guidance document covering recommendations for how to make minor changes to solid oral dosage forms subject to an over-the-counter monograph. The change is intended to make it easier for companies to develop new dosage forms for products, including chewable tablets, orally disintegrating tablets or films, without the FDA needing to issue a monograph order.
Generic drug policy team reinstated 💊 — Endpoints News' Zachary Brennan reports that the FDA "has reinstated a generic drug policy team that was laid off in April". That team was primarily responsible for creating product-specific guidance documents intended to help accelerate the development of generic competition to complex pharmaceutical products.
FDA approves Moderna's updated COVID vaccine 💊 — The FDA approved Moderna's new COVID-19 vaccine, leading to significant outcry from some of Kennedy's more vaccine-skeptical supporters. Kennedy wrote, "Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller protein. The FDA will monitor and collect data throughout the trial for every adverse outcome—not just a table list of expected outcomes".
Hernia mesh labeling guidance issued 💉 — A new draft guidance published by the FDA's Center for Devices and Radiological Health aims to make the package labeling of these products "concise, consistent, and easily understandable" to help health care providers find information quickly and easily.
MDUFA reauthorization kickoff scheduled 💉 — The FDA announced that it will soon do the same for the Medical Device User Fee program, known as MDUFA. The initial public meeting will focus on the reauthorization of the program through fiscal year 2032. It will be held on Aug. 4, 2025.
Rare Disease Innovation meeting set 💊 — The FDA is set to hold a series of meetings later this year focused on "Rare disease Innovation, Science and Exploration" (RISE) as part of a user fee-directed effort to explore cross-cutting and common issues faced by developers of drugs and biologics for rare diseases.
FDA meeting on oral fluoride scheduled 💊 — The agency has announced that it is set to hold a public meeting on July 23 to "seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population". HHS Secretary Kennedy has said that "Ending the use of ingestible fluoride is long overdue," leaving little doubt of what the FDA is leaning toward doing.
Upcoming Pediatric Advisory Committee meeting — The FDA announced that it will hold a meeting of its Pediatric Advisory Committee on July 9 to "discuss post-marketing pediatric-focused safety reviews" of five medical devices, four biologics, and 21 drugs. The three vaccines under review — Dengvaxia, Fluzone Quadrivalent and Gardasil 9 — are potentially notable because the FDA and HHS have been more heavily scrutinizing vaccines for pediatric indications.
Notable CBER departures 💊 — Julie Tierney, former FDA chief of staff and most recently deputy director of CBER, resigned this week after, she said, "it became clearer that there was no intention to keep me at FDA" after being placed on administrative leave. Ingrid Markovic, one of CBER's more senior gene therapy and vaccine science advisors on quality topics, also announced her departure last week.