🧴 FDA stalled OTC access for safer allergy drugs

FDA leadership has argued that drugs should be over the counter unless they’re unsafe or need monitoring — but the FDA stalled for years after a 2001 advisory panel backed OTC access for newer, safer second-generation antihistamines, leaving patients with easier access to older, riskier allergy meds. The delay illustrates how prescription status can restrict access, distort pricing through insurance, and perversely steer care toward less safe options.

The move

• FDA Commissioner Marty Makary said “everything should be over the counter” unless safety or monitoring requires a prescription.

• Despite an FDA advisory panel recommendation in 2001, the agency delayed switching second-generation antihistamines (loratadine, cetirizine, fexofenadine) to OTC status.

• During that period, first-generation antihistamines (e.g., diphenhydramine, chlorpheniramine) remained widely available OTC despite well-known sedation and overdose risks.

Why it Matters for Care

• When safer options are kept prescription-only, patients may default to readily available older antihistamines with higher sedation burden — raising risks for driving, workplace safety, and pediatric exposures.

• Prescription requirements can increase out-of-pocket costs indirectly: once a drug is “Rx,” it often routes through insurers/PBMs, reducing cash-price competition and contributing to higher list prices.

• OTC switches can reduce prices when coverage falls away and consumers shop on cash price — the article cites post-switch price drops for loratadine (Claritin) and omeprazole (Prilosec).

Between the Lines

• Incentives cut against OTC switches: prescription status can expand third-party payment and protect pricing power, so manufacturers may resist reclassification even when safety supports it.

• The article argues the FDA often defers to manufacturers even though the agency can initiate reclassification itself or respond to requests from other parties (including states), and Congress can mandate changes.

• “Regulatory capture” dynamics: a system that rewards restricted access can slow liberalization even when clinicians and evidence support easier access.

What to Watch

• Whether Makary’s FDA uses its own authority more aggressively to initiate OTC switches rather than waiting for manufacturer applications.

• Congressional proposals to flip the evidentiary default (presume OTC after extensive population-level safety experience unless FDA shows why Rx is needed).

• Momentum for international reciprocity frameworks (allow OTC sales if nonprescription in peer regulators such as Australia/Canada/UK, with disclosure that FDA hasn’t formally approved the switch).

• Next drug classes likely to test the politics and practicality of broader OTC access: naloxone formulations, oral contraceptives, albuterol inhalers, and HIV PrEP/PEP.

Source: Reason