Women seeking relief from vaginal dryness and painful intercourse may eventually have one fewer doctor’s appointment to schedule. On Oct. 30, the Food and Drug Administration (FDA) announced it is working with manufacturers to explore making vaginal estrogen available over the counter. The agency has not approved a switch or announced a timetable. But why should women need a prescription for these treatments in the first place?
Other countries already provide alternatives. Britain allows eligible women to purchase certain vaginal estrogen products after a pharmacist’s assessment. Sweden and Norway permit nonprescription sales of estriol vaginal cream at pharmacies. Americans should have at least as much freedom to obtain relief.
Vaginal estrogen treats symptoms caused by the decline in estrogen accompanying menopause. These can include dryness, burning, irritation, and painful intercourse. Low-dose preparations deliver estrogen directly to affected tissues, with little entering the bloodstream. Vaginal estrogen can also help reduce recurrent urinary tract infections (UTIs) in patients after menopause. Patients whose symptoms are confined to the vaginal and urinary tract can use local treatment without taking systemic hormone therapy. Others may need it even while taking oral or transdermal hormones. Britain’s National Institute for Health and Care Excellence recommends vaginal estrogen for these symptoms, including in patients already using systemic treatment.
Britain’s experience provides a straightforward comparison. Since Sept. 2022, eligible women have been able to purchase Gina vaginal tablets without a prescription. Each tablet contains 10 micrograms of estradiol. The British regimen begins with one tablet daily for two weeks, then one tablet twice weekly. This is the same strength and schedule prescribed for Vagifem in the United States.
British women must undergo pharmacy screening, and the nonprescription indication is limited to women 50 and older who have not had a period for at least a year. Pharmacists assess suitability and identify circumstances that warrant referral to a physician. Britain also permits nonprescription access to Ovesse, an estriol vaginal cream, after a suitability assessment.
Sweden’s medicines database classifies Ovesterin estriol cream as nonprescription, and a Norwegian pharmacy guide confirms that patients can purchase it without a prescription in Norway. Norway requires mandatory pharmacist counseling before each purchase of certain nonprescription medicines. Ovesterin is not among them.
The American College of Obstetricians and Gynecologists (ACOG) already supports over-the-counter access to hormonal contraception, including birth control pills. It has also advocated removing the boxed warning from low-dose vaginal estrogen, arguing that it discourages prescribing and limits access to effective treatment. The warning, largely based on studies of systemic hormone therapy, cautioned about risks of cancer, cardiovascular disease, blood clots, and dementia, even though studies of low-dose vaginal estrogen have not shown those increased risks. ACOG argues that the warning has unnecessarily discouraged clinicians from prescribing an effective treatment. Although ACOG has no publicly published position on over-the-counter vaginal estrogen cream sales, its support for informed self-selection of hormonal contraceptives provides a reasonable basis for urging it to support nonprescription vaginal estrogen as well.
Drugmakers may have little incentive to pursue over-the-counter status. Insurers generally cover prescription drugs but not over-the-counter medications, allowing manufacturers to charge third-party payers prices that consumers might resist paying directly. In a 2020 policy analysis, Michael Cannon and I noted that after the Affordable Care Act required insurers to cover prescription contraceptives without patient cost-sharing, prices for hormones and oral contraceptives rose 108 percent from 2013 to 2019, nearly three times the rate of overall prescription drug prices. Manufacturers may understandably hesitate to abandon such a lucrative arrangement.
Britain’s approach also invites a broader discussion about pharmacists’ clinical responsibilities. Its regulators recognize that pharmacists can assess whether a patient is an appropriate candidate for treatment and determine when referral is warranted. American policymakers should take pharmacists’ capabilities seriously as well.
As Marc Joffe and I explained in a Cato briefing paper, expanding pharmacists’ prescribing authority can make treatment for routine conditions more convenient. Allowing women to purchase vaginal estrogen without a prescription, or to obtain it directly from a pharmacist authorized to prescribe it, could spare them a separate physician’s appointment and its associated costs, travel, and time away from work or caregiving. States should also allow pharmacists to test and treat common, self-limited conditions within their scope of practice, with appropriate referral when symptoms suggest something more serious. Idaho, Colorado, and Montana were among the first states to permit independent pharmacist prescribing to varying degrees.
Today’s U.S. pharmacy graduates earn a Doctor of Pharmacy (PharmD) degree, typically after six to eight years of college and professional education. Their coursework includes pharmacology, the study of how drugs act in the body. Pharmacists check prescriptions for potentially harmful interactions, counsel patients on proper use and side effects, and advise physicians and other health professionals on medication selection and dosing. They draw directly on that training to assess whether a medicine is appropriate for a particular patient.
Like physicians, pharmacists should practice within their competence. Their training and the clinical task at hand should determine those limits. The American Medical Association has actively opposed expanding pharmacists’ scope of practice, citing patient safety concerns. However, using state licensing laws to prevent qualified pharmacists from providing these services protects incumbent providers from competition and infringes on patients’ freedom to choose who provides their care
Federal and state policymakers have distinct responsibilities here. The FDA determines whether a particular drug may be marketed without a prescription. States determine which licensed professionals may prescribe prescription drugs. The FDA should facilitate nonprescription access to vaginal estrogen, while states should expand the range of services pharmacists can provide independently.
Competent adults should be free to use accurately labeled medications without requiring professional permission.
Pharmacist screening can reduce the inconvenience of obtaining treatment compared with requiring a physician’s prescription. It still places a professional between a patient and the product. Women should be free to seek advice from pharmacists and physicians without the government making that advice a mandatory condition of purchase.
Accurate warnings matter. Unexplained vaginal bleeding and certain medical histories warrant evaluation. Instructions should explain appropriate use, potential adverse effects, and when to seek care. Consumers routinely rely on this information when choosing nonprescription medicines. The FDA should examine whether understandable labeling and other information can support informed decisions about a particular product.
The FDA has established a pathway that allows additional steps beyond labeling to help consumers select and use certain nonprescription drugs without professional supervision. That gives manufacturers another potential way to address specific safety concerns while expanding access.
FDA deserves credit for considering easier access to vaginal estrogen. It should follow through. States should also allow pharmacists to provide more care within their scope of practice. Both reforms would give patients more options.
Women can decide when to seek professional advice, whether from a physician or a pharmacist. The government should not make that decision for them.