WASHINGTON, D.C. — The U.S. Food and Drug Administration announced a sweeping set of reforms and enforcement actions last week aimed at lowering prescription drug costs and protecting children from unsafe, unapproved medications — signaling one of the most aggressive regulatory pushes in years.
On Wednesday, the agency unveiled new draft guidance designed to accelerate the development of biosimilars — lower-cost alternatives to complex biologic drugs that treat cancer, autoimmune disorders, and other chronic conditions. The move could dramatically reduce costs for millions of Americans who depend on biologics, which account for more than half of U.S. drug spending despite representing just 5% of prescriptions.
The guidance eliminates many costly human comparative studies that the FDA now considers unnecessary, instead allowing companies to rely on advanced laboratory testing to prove biosimilarity. The agency also said it will simplify rules for approving biosimilars as “interchangeable” with name-brand biologics, a designation that enables pharmacists to substitute them more easily.
“Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America,” said FDA Commissioner Marty Makary. “By streamlining the biosimilar development process, we can achieve massive cost reductions for advanced treatments.”
Health and Human Services Secretary Robert F. Kennedy Jr. framed the initiative as part of President Trump’s broader directive to “Make America Healthy Again,” emphasizing that the reforms could remove long-standing barriers that have slowed biosimilar competition.
Currently, the FDA has approved 76 biosimilars — a small fraction compared to over 30,000 approved generic drugs — and only about 10% of biologics expected to lose patent protection in the coming decade have a biosimilar in development.
Just two days later, on Friday, the FDA announced a separate crackdown on unapproved ingestible fluoride prescription products marketed for children. The agency sent enforcement notices to four companies, warning of possible action against those selling fluoride-containing drugs labeled for use in young children or those at low risk for cavities.
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” said Kennedy. “It’s scary that these products have been used for decades without approval.”
The agency cited growing scientific concern that ingestible fluoride — used for decades despite never being reviewed by the FDA — may alter the gut microbiome and carry potential neurodevelopmental risks. A recent meta-analysis linked higher fluoride exposure with lower IQ scores, while other studies found no meaningful reduction in tooth decay for baby teeth.
The FDA’s action stems from the Trump administration’s “Make Our Children Healthy Again” strategy, which ordered a federal review of fluoride’s risks and benefits. The agency has also sent advisories to health professionals and launched plans for a new national oral health research agenda in partnership with the National Institutes of Health.
Together, the dual announcements mark a defining week for the FDA — tackling both drug affordability and child safety through regulatory overhaul and renewed scientific scrutiny.
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