WASHINGTON, D.C. — The Food and Drug Administration moved aggressively in mid-December to speed promising drug reviews, loosen long-standing evidence barriers, strengthen food recall enforcement, and court private-sector innovation, signaling a sweeping shift in how the agency pursues public health protection and medical advancement.
The FDA awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed or refractory multiple myeloma after reviewing strong Phase 3 trial results that showed major gains over standard treatment. More than 80 percent of patients receiving the therapy remained progression-free at three years, according to data released in late November and published in the New England Journal of Medicine. The award brings the total number of products recognized under the Commissioner’s National Priority Voucher pilot program to 16 at that point.
FDA Commissioner Dr. Marty Makary said the agency acted within days of the trial data becoming public, contacting the manufacturer to initiate the voucher process. The program is designed to compress review timelines for therapies that address public health crises, major unmet needs, domestic manufacturing priorities, or affordability challenges, with review decisions targeted within one to two months of application submission.
Days later, the agency announced it had removed a major obstacle to using real-world evidence in regulatory reviews. Under new guidance for certain medical device submissions, the FDA will now accept real-world evidence without always requiring identifiable individual patient data, a departure from prior practice that limited the usefulness of large datasets. The agency also signaled it may update guidance for drugs and biologics.
The change opens the door to broader use of de-identified data from national disease registries, hospital systems, insurance claims, and electronic health records, resources that track outcomes across millions of patients in everyday clinical settings. Makary said the reform would allow regulators to draw meaningful conclusions from large datasets while preserving patient privacy and accelerating access to treatments.
On the consumer protection front, the FDA warned retailers to tighten recall practices after an investigation tied to a multistate infant botulism outbreak linked to ByHeart infant formula. Agency inspectors conducted more than 4,000 retail checks and found recalled formula still on shelves for weeks in some cases, across more than 175 locations in 36 states. Warning letters were sent to several major retailers that failed to remove the recalled products promptly.
The FDA said retailers have a critical responsibility as the final gatekeepers in the supply chain, particularly when recalls involve foods for infants and young children. The ByHeart recall began November 8 and was expanded days later to include all products from the line. The agency said it has not found recalled formula on store shelves since November 26.
The agency also issued a request for information seeking input from venture capital firms on a new contracting model aimed at working more directly with innovative companies developing technologies in fields such as artificial intelligence, biotechnology, and medical devices. The proposal would allow FDA to form direct relationships with qualified venture capital firms, enabling companies within their portfolios to compete for task orders without relying on traditional federal contractors.
Chief AI Officer Jeremy Walsh said the effort is intended to bypass entrenched intermediaries and focus federal dollars on scalable technologies that advance public health. Responses to the request are due January 18.
Rounding out the week, the FDA granted two additional national priority vouchers to investigational products aimed at improving affordability: an oral PCSK9 inhibitor for lowering LDL cholesterol and an antibody-drug conjugate targeting TROP2 for cancer treatment. With those awards, the agency said 18 products have now received vouchers since the pilot program launched in June.
Together, the actions reflect an FDA pushing on multiple fronts at once, compressing drug review timelines, expanding acceptable evidence, tightening oversight of food safety, and rethinking how the federal government partners with innovators in a rapidly evolving health care landscape.
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