FDA Push for Nonprescription Drugs Risks Cost Shift to Consumers

The FDA’s call to industry to shift more prescription medications to over-the-counter stands to threaten drug coverage for patients as nonprescription products are generally excluded from health plans.

US Food and Drug Administration Commissioner Marty Makary is seeking to make more drugs available without a prescription as part of the Trump administration’s efforts to slash health-care costs. The agency chief has said “everything should be over-the-counter” unless the drug is addictive, unsafe, or requires monitoring.

But moving a medication to nonprescription status typically ends insurance coverage, potentially limiting patient access to drugs if more products shift under the FDA’s initiative.

“Once things are available over-the-counter, access is a little bit more uneven,” Zachary Predmore, a health policy researcher at nonprofit research organization RAND, said in an interview. “The impact on price can really vary.”

Nonprescription drugs that have been on the market longer are generally more affordable for consumers given the competition between products that drives down costs. Medicines more recently approved are likely to have a higher price tag.

Ibuprofen, a pain reliever available over-the-counter since 1984, can cost consumers as low as $2, depending on the supply and manufacturer. Perrigo Co.‘s birth control drug Opill, which became nonprescription in 2023, can run between $20 and $90 depending on the supply.

While prices vary, some of them remain high for consumers, the National Association of Chain Drug Stores said this month in response to the agency’s request for information on shifting to nonprescription drugs.

“The FDA is going to have to thread a very fine balance between ensuring safety and expanding coverage,” said Mariana Socal, an associate professor at Johns Hopkins Bloomberg School of Public Health.

Shifting Costs

Some health plans provide coverage for over-the-counter drugs only when a patient receives a prescription from a health-care provider to qualify for it. Some state Medicaid programs or Medicare Advantage plans also determine whether to cover products.

A federal law passed in 2020 authorized health savings accounts and flexible spending accounts to cover a wide range of nonprescription drugs.

Still, most health plans exclude coverage and shift the costs to consumers.

The decision can force patients to pay more out-of-pocket compared to when they paid a lower insurance copay to access the medicine.

“The drug can be cheaper in the over-the-counter setting because of the notion that you will bypass the administrative costs of insurance,” Socal said. “But plans could respond with coverage exclusions.”

Health plans welcome ideas to bring down the drug prices manufacturers charge Americans and “to empower consumers to make the best health-care decisions for themselves and their families,” said Chris Bond, a spokesperson for AHIP, a trade association representing health insurance companies.

Drug chain stores are recommending the FDA coordinate with Congress, the Department of Labor, and the Department of the Treasury to encourage policy changes that require public and private payers to cover nonprescription products.

The American Pharmacists Association suggested that rather than reclassifying prescription drugs as nonprescription, the FDA should review and recommend pathways that promote the use of pharmacists, rather than solely providers such as doctors, to safely prescribe medications.

The Benefits

At the same time, studies indicate that financial benefits can arise from products shifting to over-the-counter.

The Consumer Healthcare Products Association found in 2022 that on average, every dollar spent on those medicines saved the US health-care system $7.33, resulting in an overall annual savings of around $167 billion.

“Patients have to pay at the register, but they also can avoid costs like having to visit the doctor as well as a number of administrative delays,” Scott Furness, senior vice president of regulatory and scientific affairs at CHPA, said in an interview.

Many consumers are also uninsured, “so the greater availability OTC will help more people have access to the drugs,” said Heidi Forster Gertner, a partner at Hogan Lovells US LLP, representing pharmaceutical companies.

Approximately 27 million Americans didn’t have health insurance in 2024, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The Congressional Budget Office estimates the uninsured population will rise over the course of the next decade as a result of the end of Covid-19 pandemic-related Medicaid policies and the expiration of enhanced subsidies under the Affordable Care Act.

“This could be a double-edged sword for patients,” said Steve Callahan, senior director of advisory and insights at MMIT, a market access consultant for the pharmaceutical and health-care industry. “They have access to these drugs without the need of going through their insurance, but at the same time, they are likely responsible for 100% of the cost.”