UPDATE: FDA gave Opill full approval on July 13, 2023.
Advisers to the Food and Drug Administration (FDA) have voted unanimously to recommend making a birth control pill available without a prescription.
The 17 to 0 vote by 2 advisory panels came despite reservations voiced by some agency officials regarding the quality of the data used to support switching the birth control pill, being marketed as Opill, from prescription to over the counter (OTC). The agency did not express concerns about the safety and effectiveness of the drug.
Nod expected this summer
While it is not mandatory that the full FDA follow the recommendation of its committees, the vote is expected to weigh heavily on its final decision which is expected in late summer (UPDATE: FDA gave Opill full approval on July 13, 2023.). If approved, the Opill would be the first birth control pill made available for OTC sales in the United States.
The FDA approved Opill as a prescription drug in 1973 and it must be taken daily. The medication contains only 1 hormone, progestin (a synthetic form of progesterone) and helps prevent pregnancy by stopping ovulation, thinning the lining of the uterus, and preventing sperm from reaching an egg by thickening mucus in the cervix. Progestin-only pills are considered safer alternatives to combination pills (which also contain estrogen) with fewer side effects and health risks, but they are less effective unless taken at the same time each day.
More access, fewer unintended pregnancies
“Opill has the potential to have a huge positive public health impact,” stated Kathryn Curtis, a scientist at the Centers for Disease Control and Prevention, following the committee vote. Making the medication available OTC should increase access and reduce unintended pregnancies, she added.
For years, advocacy groups have been encouraging an OTC alternative to prescription-only birth control therapies and many major medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, support OTC availability.
Pros and concerns
The meeting spanned 2 days and involved the convening of 2 FDA advisory groups: the Obstetrics, Reproductive and the Urologic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee. NPWH’s President-elect Dr. Komkwuan P. Paruchabutr, DNP, WHNP-BC, FNP-BC, CNM, FACNM, who is also Co-Chair, NPWH Advocacy and Government Relations Committee, testified in support of making the Opill birth control pill available.
During the sessions, some committee members expressed concern about whether patients will use the product as directed—especially those with health conditions and adolescents.
FDA officials pointed out numerous weaknesses in the company’s presentation particularly a lack of information on whether women, including those with lower literacy skills, would be able to understand the drug’s instruction label. Failure to take the birth control pill at the same time every day could lead to unintended pregnancy, they noted.
Other committee members responded that they believed most women could determine independently whether the medication is appropriate to use.
The company sponsor, Perrigo, which acquired the drug when it bought French drug firm HRA Pharma last year, also countered that even when birth control pills are administered via prescription, women can still miss doses. Perrigo presenters then provided clinical studies in the literature showing that ~15% of women may miss 3 or more doses at least once per month.
Some committee members also expressed concern regarding side effects such as vaginal bleeding, and whether patients—particularly adolescents—would know to consult with a health care provider. Others questioned whether the pill would be less effective in overweight patients.
An additional reservation expressed was whether women with either active breast cancer or a history of the disease would know to refrain from using the medication. Other committee members responded that they didn’t anticipate that to be an issue as most patients with breast cancer already know that they should avoid hormonal contraceptive use.
While Karen Murry, MD, Deputy Director of the FDA’s Office of Non-Prescription Drugs, recognized the importance of increasing access to effective contraceptives, she acknowledged that “the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting.”
Perrigo is petitioning the FDA to approve the OTC version for all patients of reproductive age, including teenagers.
OTC overseas precedent
During the meeting, Perrigo representatives claimed that making birth control available over the counter could prevent more than 37,000 unintended pregnancies in 1 year. The company also noted that OTC birth control pills are already available in several other countries.
Some panel members countered that other countries often do not treat nonprescription medications in the same manner as in the US. In many, in addition to prescription and OTC use, there’s often a third category: pharmacist dispensed. While a patient in another country may not have to obtain a prescription from a physician, they may have to speak to a pharmacist who may or may not dispense the medication.
“We need to trust women,” Dr. Katalin Roth, a professor of medicine at the George Washington University of School of Medicine and Health Sciences, stated following the vote. “I urge the FDA to approve.”
The contents of this feature are not provided or reviewed by NPWH.