FDA wants to make more drugs available over the counter, but experts have raised safety concerns

The U.S. Food and Drug Administration is reportedly considering whether more prescription drugs should be sold without a prescription at pharmacies. In an interview Wednesday, FDA Commissioner Martin Makary told CNBC that “everything should be over-the-counter” except for drugs deemed dangerous or addictive or that require clinical monitoring.

Makary said the agency is reviewing how it decides which drugs can be sold with or without a prescription from a health care professional. He suggested that prescription vaginal estrogens or anti-nausea medications, for example, could become over-the-counter medications.

It may be “reasonable” to make these drugs over-the-counter, says Gina Moore, a pharmaceutical law expert at the University of Colorado Anschutz, but she adds: “I think ‘everything’ is definitely an exaggeration.”

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It’s unclear exactly how the FDA is revising the rules regarding over-the-counter drugs or what the timeline will be, but in the same interview, Makary said the agency is following “the appropriate regulatory processes.” The FDA declined a request for comment from Scientific American.

To understand how this decision could change access to medicines, Scientific American spoke with pharmacy experts about the proposed change in prescription drug policy, which drugs could be affected and potential safety concerns.

How are medications currently designated as over-the-counter?

Over-the-counter medications require an FDA-approved monograph, a standard set of rules that apply to all manufacturers of the drug in question.

Some exceptions require a prescription, such as using an over-the-counter medication at a higher dose or treating a different medical problem than what is listed on the label, Moore says.

Companies may also apply to sell a prescription drug entirely or partially as an over-the-counter drug through a process called “Rx to OTC switching.” These applications undergo careful and rigorous scientific review to ensure that the drugs can be safely administered to people without clinical supervision.

How would changing FDA rules to make more drugs available over-the-counter affect accessibility?

The move could make some medications more accessible, but Moore and other pharmacy experts worry it could also place greater medical liability on the individual, potentially increasing the risk of safety issues or drug abuse.

“There’s no end to the nuances that you’re asking patients to be more aware of,” from understanding how to take medications correctly to clarifying drug interactions that can occur, says Paul Beninger, a retired professor of public health and community medicine at Tufts University.

What medications would potentially be available over the counter?

The FDA has not revealed a list of drug candidates that could move to OTC.

But Moore says prescription drugs that have already gone through the FDA’s Rx-to-OTC process could provide insight into other drugs that might receive similar treatment in the future. Contraceptive medications, such as “Opill,” have moved from prescription to over-the-counter sales. Some nasal steroids for allergies have also become over-the-counter. “And that makes a lot of sense, because they only work locally in the nose, and you don’t really worry about absorption and systemic side effects,” says Moore.

“There is general consensus on a number of types of drugs that would be [sold] over-the-counter medications, like birth control pills, allergy medications, heartburn medications,” says Beninger. “The reason is: we understand how these medications are used and how they interact in the body when they’re developed.”

What drugs should not become OTC?

In the interview with Makary, he said prescription drugs that require additional monitoring or are addictive or considered dangerous would not be eligible for OTC. But these criteria can be difficult to assess without further details.

“When you say, ‘All medications unless they’re unsafe,'” Moore says, “that’s a tough question to answer.” »

Experts say regulators may consider some general factors, from side effects to drug administration.

For example, a very important safety factor, Beninger says, is a drug’s “therapeutic window,” the range between the lowest dose needed to observe the drug’s activity in the body and the highest level before the drug becomes toxic. Drugs with a very narrow therapeutic window, such as heart and lung medications, require more diligent monitoring and administration.

“The lower end just shows some activity, but you don’t have to go much higher before you detect toxicities,” so for these therapeutic windows you need very careful titration to the appropriate dose, Beninger says.

And some medications can be extremely toxic, he says. For example, medications intended to treat addiction, such as opioids and benzodiazepines, can cause significant health problems if taken for long periods of time without supervision. “Anything that is a controlled substance has some degree of abuse or misuse or addiction potential,” Moore says. Even aspirin or acetaminophen (the active ingredient in Tylenol) can be toxic in high enough doses.

Generally speaking, Moore says medications intended for occasional use, such as cold or allergy medications, might make more sense to sell over-the-counter than those that must be taken regularly for a chronic illness, such as blood pressure medications. The latter medications “tend to require increased monitoring,” she says. And medications with more complicated delivery systems, such as injections or intravenous infusions, may also require monitoring.

Medications can also interact with certain foods or substances, like other medications. “If you have a drug that impairs another drug, that means you have to [either] take them at different times of the day or increase the dose of one of the medications,” says Beninger. “Similarly, there are some medications that, when you take them with another medication, can improve the activity of the [first] drug and become toxic.

Warnings about these risks can be placed on drug labels, but “it can get very complicated, very quickly,” Moore says.

How might this affect insurance coverage?

Making more medications available over-the-counter could increase access, but there are nuances, Moore says. “Many, if not most, prescription plans do not cover over-the-counter medications,” she says.

Most people don’t often buy over-the-counter medications through their insurance, even if they’re covered, she says. “For some people, that’s totally fine, but others might be like, ‘Well, I can’t afford something that I’m used to paying $10 for and I’m going to have to pay $30 for right now,'” she says.

Any changes to allow more prescription drugs to become eligible for over-the-counter sale should be made in an open forum, he adds.

“Maybe we can find more drugs that could be brought into the transition system from prescription to over-the-counter drugs, but to say, basically, that much more drugs can go there, I don’t know. I don’t see it,” he says.