More drugs should be over-the-counter

Food and Drug Administration Commissioner Marty Makary told CNBC that he believes “everything should be over-the-counter” unless a drug is unsafe, addictive or requires monitoring. questioned.

In an interview Wednesday in Washington, D.C., Makary said the FDA aims to make changes this year that will allow more companies to create their own products. Over-the-counter prescription drugsor OTC. He noted that the agency went through “appropriate regulatory processes” to update OTC monographs, the rulebooks that determine which drugs can be sold without a prescription.

Makary said the FDA is looking at “essential, safe” prescription medications such as nausea medications and vaginal estrogen, which is used to treat menopausal symptoms such as dryness and pain.

“In my view, everything should be over-the-counter and not require a prescription unless it’s safe, you don’t need lab testing to monitor how it’s taken up by your body, or it could be used for a bad purpose or it’s addictive,” Makary told CNBC. PhRMA ForumA one-day event organized by the pharmaceutical industry’s largest lobby group.

“If it doesn’t meet those criteria, why shouldn’t a drug be available over-the-counter? So why not? Instead of, ‘Oh, you have to go through a long, tedious process if you want to go without a prescription,'” he added.

The FDA has long considered making some prescription drugs available OTC to increase accessibility, reduce health care costs and help patients continue taking their medications. For example, patients will not need to take time off work to see a doctor for a prescription or will be able to refill medications without delay.

Congress steps up effort law in november This streamlines the regulatory process for prescription-to-OTC transitions, including full, conditional, and partial “switch-over” pathways.

Makary framed the FDA’s latest effort to expand OTC access as another way to lower drug costs, a key priority of the Trump administration. He argued that placing drugs directly on store shelves would bypass insurance companies and pharmacy benefit managers and eliminate the discount-driven system that often obscures a drug’s true price.

He also said that selling drugs without a prescription promotes transparency that “keeps prices in check.” In some cases, Makary said, cash prices for over-the-counter drugs are lower than the copays patients pay for prescription drugs “while there’s a money game behind the pharmacy counter” where employers and insurers share the cost.

Some in the pharmaceutical industry pushed back on this claim. Most OTC medications are not covered by insurance; This means their prices could eclipse those of generic prescription drugs, potentially making them less affordable for patients with insurance coverage.

The Association for Accessible Medicines argued in a statement to the FDA earlier this month that “the transition of many prescription drugs to over-the-counter status could actually increase costs for patients and therefore reduce patient access to treatment.” This organization represents manufacturers and distributors of generic prescription drugs.

The FDA also has no authority to regulate drug prices. In its own comments this month, PhRMA said the agency should respect “the fundamental principle that pricing considerations may not influence FDA’s regulatory decision-making.”

PhRMA added that the FDA should not attempt to switch any prescription drug OTC without first consulting with the manufacturers. But the group emphasized that it supports the FDA’s effort to expand access to important drugs.

In his own comment this month, AstraZeneca He said several previous attempts to move cholesterol-lowering statins to OTC status “have failed, with consumers consistently having difficulty making appropriate choice decisions for themselves.”

STAT News fired Theresa Michele, the longtime director of the FDA’s office of nonprescription drugs, in December. reported In that case.