The U.S. Food and Drug Administration (FDA) has announced significant reforms aimed at reducing prescription drug costs and enhancing the safety of medications for children. This initiative, revealed last week, marks a notable shift in regulatory strategy, focusing on the acceleration of biosimilars and a crackdown on unapproved fluoride drugs.
On Wednesday, the FDA introduced new draft guidance intended to expedite the development of biosimilars, which are lower-cost alternatives to complex biologic drugs. These biologics are crucial for treating conditions such as cancer and autoimmune disorders but account for over half of U.S. drug spending despite representing only 5% of prescriptions. The agency’s new guidelines aim to streamline the approval process by removing the requirement for costly human comparative studies. Instead, companies can now rely on advanced laboratory testing to demonstrate biosimilarity.
Marty Makary, the FDA Commissioner, emphasized the potential for significant cost reductions, stating, “Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America.” The FDA’s efforts aim to simplify the rules for approving biosimilars as “interchangeable” with brand-name biologics, allowing easier substitutions by pharmacists.
Currently, the FDA has approved 76 biosimilars, a stark contrast to over 30,000 approved generic drugs. Alarmingly, only about 10% of biologics losing patent protection in the next decade have a biosimilar in development. This highlights the need for the FDA’s reforms, which Secretary of Health and Human Services Robert F. Kennedy Jr. has framed as part of President Trump’s broader initiative to “Make America Healthy Again.”
On the following Friday, the FDA took further action by enforcing regulations against unapproved ingestible fluoride products marketed for children. The agency issued enforcement notices to four companies, warning them of potential legal consequences for selling fluoride-containing drugs aimed at young children or those at low risk for cavities.
Kennedy remarked, “This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride.” The FDA’s concerns stem from emerging research indicating that ingestible fluoride, which has been used for decades without FDA review, may negatively impact the gut microbiome and pose neurodevelopmental risks. A recent meta-analysis suggested a correlation between higher fluoride exposure and lower IQ scores, while other studies indicated no significant reduction in tooth decay among baby teeth.
These actions align with the Trump administration’s “Make Our Children Healthy Again” strategy, which mandated a federal review of fluoride’s risks and benefits. The FDA is also collaborating with the National Institutes of Health (NIH) to establish a new national oral health research agenda.
The simultaneous announcements underscore a pivotal week for the FDA, addressing critical issues of drug affordability and child safety through enhanced regulatory measures and renewed scientific inquiry. As these reforms unfold, they may reshape the landscape of pharmaceutical access and safety in the United States.
