FDA Considers Expanding Over-the-Counter Drug Availability

The FDA is reportedly considering broadening the types of drugs that can be sold without a prescription, a move some pharmacy experts say could raise safety risks. The U.S. Food and Drug Administration is reportedly mulling whether more prescription drugs should be sold over the counter (OTC) at pharmacies. In an interview on Wednesday, FDA commissioner Martin Makary told CNBC that “everything should be over the counter” except drugs that are deemed unsafe 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 practitioner. He suggested prescription vaginal estrogen or antinausea medications, for example, could become OTC.

Those specific drugs may be “reasonable” to make OTC, says Gina Moore, a pharmacy law expert at the University of Colorado Anschutz, but she adds, “I think ‘everything’ is certainly an overstatement.” Over-the-counter medications require an FDA-approved monograph—a standard set of rules that applies to all manufacturers of the drug in question. There are some exceptions that require a prescription, such as using an OTC drug at a higher dose or treating a different medical condition than what is indicated on the label, Moore explains. Companies can also request to sell a prescription drug fully or partially as a nonprescription drug through a process called an “Rx-to-OTC” switch. These applications undergo careful, rigorous scientific review to ensure that the medications can be safely given to people without clinical supervision.

The move could make some medications more accessible, but Moore and other pharmacy experts worry that it could also put more medical responsibility on the individual—potentially increasing the risk of safety issues or drug misuse. “There’s no end to the nuances here that you’re asking patients to be more aware of,” from understanding how to take the drugs correctly to clarifying what drug-to-drug interactions may occur, says Paul Beninger, a retired professor of public health and community medicine at Tufts University.

The FDA hasn’t revealed a list of drug candidates that could transition to OTC. But Moore says prescription drugs that have previously gone through the FDA’s Rx-to-OTC track could give insight on others that might receive similar treatment in the future. Birth control medications, such as “Opill,” switched from prescription to nonprescription. Some nasal steroids for allergies have also become OTC. “And those make a lot of sense, because they’re just acting locally in the nose, and you’re not really worried about absorption and systemic side effects,” Moore says.

“There’s general agreement on a number of types of drugs that would be [sold] over the counter, such as birth control pills, allergy medications, heartburn drugs,” Beninger says. “The reason is: there’s understanding about how those drugs are used and how they interact in the body when they’re developed.”

In the interview with Makary, he said prescription drugs that require additional monitoring or that are addictive or considered unsafe wouldn’t become eligible for OTC. But those criteria can be difficult to evaluate without further clarification. “When you say, ‘Every drug except if they’re not safe,’” Moore says, “it’s a hard question to answer.” Regulators may consider some broad factors—from side effects to drug administration—the experts say.

For example, a very important safety factor, Beninger says, is a drug’s “therapeutic window,” the range between the lowest dosage needed to see drug activity in the body and the highest level before the drug becomes toxic. Drugs with very tight therapeutic windows, such as heart and pulmonary drugs, require more diligent monitoring and administration. “The lower end just shows some activity, but then you don’t have to go much higher before you find toxicities,” so for those therapeutic windows, you need a very careful titration to the proper dose, Beninger says.

And some drugs can be extremely toxic, he says. For example, drugs to treat addiction, such as opioids and benzodiazepines, can cause significant health issues if they are taken for extended periods without monitoring. “Anything that's a controlled substance has some degree of abuse or misuse or addictive potential,” Moore says. Even aspirin or acetaminophen (the active ingredient in Tylenol) can be toxic in high enough doses.

Generally, Moore says that drugs intended for occasional use, such as cold or allergy medications, might make more sense to sell OTC than those that need to be taken routinely for a chronic condition, such as blood pressure medication. The latter drugs “tend to require more monitoring,” she says. And drugs with more complicated delivery systems, such as injections or intravenous drips, may also require supervision.

Drugs can also interact with certain foods or substances—such as other medications. “If you have a drug that impairs another drug, that means that you need to [either] take them at different times of the day or increase the dose of one of the drugs,” Beninger says. “By the same token, there are some drugs that, when you take them with another drug, it can enhance the activity of the [first] drug and become toxic.” Warnings about these risks can be put on medication labels, but “it can get really complicated, really quickly,” Moore says.

Making more drugs available over the counter could increase access, but there are nuances, Moore says.“Many, if not most, prescription plans won’t pay for over-the-counter drugs,” she says. Most people don’t often run purchases of OTC medications through their insurance, even if they are 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 that I’m going to have to pay $30 for now,’” she says.

Any changes to allow more prescription drugs to become eligible to be sold OTC need to be done in an open forum, he adds. “Maybe we can find more drugs that could be put into the Rx-to-OTC switch, but to say, wholesale, that so many more drugs can go there, I don’t know. I don’t see it,” he says.