The Food and Drug Administration is poised to significantly alter its drug approval process and expand access to medications currently requiring prescriptions, according to FDA Commissioner Marty Makary. The agency aims to create changes this year that would allow more companies to offer prescription medicines over the counter, or OTC.
Makary told CNBC that the FDA is undertaking a review of existing regulations, specifically focusing on updating OTC monographs – the rulebooks governing which drugs can be sold without a prescription. He indicated the agency is prioritizing “basic, safe” prescription drugs, citing nausea medications and vaginal estrogen, used to treat menopausal symptoms, as potential candidates for over-the-counter availability.
The move aligns with a key priority of the Trump administration: lowering drug costs. Makary framed expanded OTC access as a means to achieve that goal, removing layers of prescription-related expenses.
Alongside the OTC push, the FDA is also revising its standard for approving new drugs. Traditionally, the agency has required two rigorous studies to demonstrate safety and efficacy. Yet, Makary and a top deputy, Vinay Prasaid, announced in a New England Journal of Medicine article that the FDA’s “default position” will now be to require only one study for new drugs and other novel health products.
According to the article, this shift reflects advancements in drug research that have made the process “increasingly precise and scientific.” Makary and Prasaid predict the change will “lead to a surge in drug development.”
The changes are the latest in a series of adjustments to longstanding FDA standards and procedures under Makary’s leadership, all with the stated intention of reducing bureaucracy and accelerating the availability of new medicines.
The Trump administration also recently revived a pilot program aimed at reworking drug pricing within the 340B program, a controversial federal drug discount program, according to Stat News. This program provides discounted drugs to hospitals and clinics serving vulnerable populations.
Meanwhile, a lawsuit has been filed alleging that pharmacy benefit managers, including CVS and Express Scripts, negotiated large rebates from Mylan for the EpiPen device, benefiting the PBMs rather than consumers, Yahoo News reported.
Merck recently received FDA approval for Enflonsia, a shot to protect infants against RSV, the leading cause of hospitalization among babies. The wholesale price is set at $556 a dose, the same as Sanofi and AstraZeneca’s Beyfortus, though the two products differ in dosage requirements, according to STAT.
