Jeffrey A. Singer
The Food and Drug Administration approved a new injectable drug on June 18 that provides pre-exposure prophylaxis (PrEP) against HIV, requiring individuals to take it only twice a year. By removing barriers to access for adults and adolescents, the FDA makes the drug, lenacapavir (brand name Yetzugo), more widely available—great news for HIV prevention. Manufactured by Gilead Sciences, clinical trials have shown that the drug offers over 99.9 percent protection against HIV for six months.
In late 2021, the FDA removed barriers to another injectable PrEP, cabotegravir (Apretude). This medication provides protection that lasts for two months, necessitating bimonthly injections.
Like all other forms of PrEP and PEP (post-exposure prophylaxis), the government requires individuals to obtain a prescription from a state-licensed health care provider to access these injectables.
Both injectables are quite costly. Yetzugo’s list price is $28,218. The FDA already permits patients with treatment-resistant HIV to access the drug, using a different administration protocol, under the brand name Sunlenca, at a cost of over $42,000 per year. The list price of Apretude is $4,025 every two months.
By contrast, a month’s supply of the daily pills Truvada and Descovy runs about $2,000 for those without insurance. And the generic version of Truvada (emtricitabine/tenofovir) sells for a dollar per pill.
Gilead points out that most people won’t have to pay the full price for Yetzugo. Third-party payers will cover the costs. Commercial insurance carriers will likely incorporate the expense into the premiums they charge beneficiaries, and government-funded health plans, such as Medicaid, may include it in their budgets. Gilead also plans to offer patient assistance programs to qualified individuals.
As I have written before, the FDA should reclassify all forms of PrEP and PEP as over-the-counter (OTC) drugs. Doing so would not only eliminate the time and money spent on a visit to a clinician’s office for a prescription, but experience shows that drug prices tend to drop when they transition from prescription-only status to over-the-counter availability. Reclassifying these drugs as OTC helps to remove the stigma that some individuals face when seeking PrEP and PEP, while also enhancing privacy. Like emergency contraceptives, OTC PrEP and PEP could even be sold in vending machines.
At least 10 states have enacted workarounds to the FDA’s prescription requirement for PrEP and PEP by expanding the scope of practice of pharmacists (state-licensed health care providers) to prescribe these drugs to individuals. These state-level reforms highlight a growing recognition that federal prescription requirements are outdated and counterproductive.
As I write in my book, Your Body, Your Health Care:
Removing unnecessary prescription requirements would unburden consumers of the unnecessary time and financial costs of visiting a doctor to obtain a prescription and waiting for a pharmacist to fill it. Consumers would also have many convenient options for purchasing OTC medications, including online services, convenience stores, airport newsstands, grocery stores, vending machines, and more. Low-income people who struggle to pay medical bills and who might otherwise forgo necessary treatment will clearly benefit from a reduction in costs.
Reclassifying PrEP and PEP as over-the-counter drugs would be a straightforward, evidence-based step toward broader access and improved public health. Life-saving medications shouldn’t be locked behind unnecessary regulatory barriers—especially when convenience, cost, and stigma continue to be significant obstacles. With powerful new options like Yetzugo now available, it’s time to empower individuals to take charge of their own HIV prevention. We shouldn’t need permission to protect ourselves. The FDA should get out of the way.