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# FDA Should Move More Drugs OTC: Opinion
- URL: https://www.fdaweb.com/fda-should-move-more-drugs-otc-opinion/
- Published: 2026-02-13T12:00:00.000Z
- Updated: 2026-09-14T13:33:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160666

A new opinion piece argues that the Trump Administration should urge FDA make a major shift in how it classifies prescription drugs by moving more medications to over-the-counter status. Writing in *The Hill*, **Jeffrey A. Singer**, a general surgeon and senior fellow at the Cato Institute, contends that FDA maintains outdated distinctions that keep relatively safe drugs behind prescription requirements while allowing some riskier medications to be sold directly to consumers. He points to asthma treatments as a prime example: epinephrine inhalers such as Primatene Mist are available over the counter, while albuterol — which he describes as more targeted and generally associated with fewer systemic side effects — remains prescription-only in the U.S., despite being available without a prescription in countries such as Australia and parts of Latin America.

The [opinion piece](https://thehill.com/opinion/healthcare/5734772-fda-regulations-drug-access/?ref=fdaweb.com) also revisits FDA’s historical handling of antihistamines. For years, first-generation antihistamines such as diphenhydramine were available over the counter despite their sedating effects, while newer, second-generation agents such as loratadine and cetirizine remained prescription-only after their initial approval in the 1990s. Although an FDA advisory panel recommended switching loratadine to over-the-counter status in 2001, the agency did not do so until 2002, with subsequent delays before other second-generation antihistamines became nonprescription.

Singer extends the argument to other categories, including oral contraceptives and HIV pre-exposure prophylaxis (PrEP). While more than 100 countries allow over-the-counter access to birth control pills, FDA in 2023 approved only a single progestin-only “mini-pill” for nonprescription sale. In the case of PrEP, some states have authorized pharmacists to prescribe the medication, but it remains unavailable for direct retail purchase without a prescription.

He also raises the possibility that newer classes of drugs, such as GLP-1 receptor agonists used for obesity and metabolic disease, could eventually be considered for over-the-counter access if long-term safety data continue to accumulate.

Beyond clinical arguments, Singer emphasizes cost and market dynamics, asserting that drugs often become less expensive once sold over the counter because consumers pay directly and comparison-shop. He cites economist **Sam Peltzman**’s proposal to reverse the burden of proof for certain drugs, so that medications with well-established safety records would be presumed eligible for nonprescription sale unless FDA demonstrates otherwise.