More medications should be without a prescription

FDA Commissioner Marty McCurry told CNBC he believes “everything should be over-the-counter” unless the drug is unsafe, addictive or requires monitoring — doubling down on a push that some in the drug industry have questioned.

In an interview Wednesday in Washington, D.C., McCurry said the FDA aims to make changes this year that would allow more companies to make prescription drugs available over the counter, or OTC. He noted that the agency is going through the “appropriate regulatory processes” to update over-the-counter monographs — the rulebooks that specify which drugs can be sold without a prescription.

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

“In my opinion, everything should be over-the-counter and not require a prescription, unless it’s unsafe, unless you need a lab test to monitor how it’s received by your body, or if it can be used for some nefarious purpose or it’s addictive,” McCary told CNBC after the PhRMA Forum, a one-day event organized by the pharmaceutical industry’s largest lobbying group.

He added: “If it doesn’t meet these criteria, why isn’t the drug available over the counter? So we have to ask, why not? Instead of saying, ‘Oh, you want to get off the prescription,’ you have to go through a long and arduous process.”

The FDA has long considered making some prescription drugs available over-the-counter to improve accessibility, reduce health care costs and help patients stay on their medications. For example, patients will not have to take time off work to see a doctor to get a prescription or can refill their medication without delay.

Congress bolstered efforts with legislation in November that streamlines the regulatory process for transitioning from prescription to OTC, including full, conditional and partial “switching” pathways.

McCurry framed the FDA’s latest push to expand access to over-the-counter medications as another way to lower drug costs, a key priority of the Trump administration. Placing drugs directly on store shelves would bypass insurance companies and pharmacy benefit managers, eliminating the rebate-based system that often obscures the true price of a drug, he said.

He also said that selling drugs without a prescription promotes transparency that “keeps prices under control.” In some cases, McCary said, cash prices for over-the-counter drugs are lower than the amounts patients pay for prescription drugs “when there is a financial game going on behind the pharmacy counter,” with employers and insurers sharing the cost.

Some in the pharmaceutical industry have pushed back on this argument. Most over-the-counter drugs are not covered by insurance, which means their prices can outperform those of generic prescription drugs and possibly make them less expensive for patients who rely on coverage.

In its comments submitted to the FDA earlier this month, the Accessible Medicines Association argued that “the conversion of many prescription medications to nonprescription status could actually increase costs to patients and thus reduce patient access to treatment.” This organization represents manufacturers and distributors of generic medical drugs.

The Food and Drug Administration also does not have the authority to regulate drug prices. In its own comments this month, PhRMA said the agency should respect “the basic principle that pricing considerations may not influence FDA regulatory decision making.”

PhRMA added that the FDA should not attempt to move any prescription drugs to OTC without first consulting the manufacturers. But the group stressed that it supports the US Food and Drug Administration’s efforts to expand access to vital medicines.

In a special comment this month, AstraZeneca Many previous attempts to convert cholesterol-lowering statins to OTC status have been “unsuccessful, with consumers consistently having difficulty making appropriate self-selection decisions,” he said.

Meanwhile, McCary told CNBC on Wednesday: “We have to trust people to make their own decisions. We have to get away from this paternalistic mentality.”

The U.S. Food and Drug Administration removed its longtime Office of Nonprescription Drugs director, Teresa Michel, from her position in December, STAT News reported at the time.