Opill, a progestin-only birth control medication, boasts a reduced risk of side effects compared to pills containing both progestin and estrogen. The consensus among advisors to the FDA is that the advantages of making this birth control pill available over the counter outweigh the associated risks.
External consultants to the U.S. Food and Drug Administration (FDA) have unanimously voted in favor of permitting the first over-the-counter availability of a birth control pill without the need for a prescription.
Should the FDA opt to adhere to this counsel, Opill, the medication in question, would mark the pioneering instance of an oral contraceptive becoming accessible without a prescription in the United States. Opill’s evaluation for non-prescription use encompasses all females of reproductive age, devoid of any age-related usage limitations.
While the FDA is not obligated to conform to the suggestions of its independent advisory panels, it is generally customary for regulatory authorities to align with such recommendations.
“Over-the-counter access to the pill will make it easier for people to physically and logistically access birth control in their communities,” Dana Singiser said. She is a co-founder of the Contraceptive Access Initiative (CAI) and a board member of Planned Parenthood Metro Washington.
“The people who may benefit the most from the pill on the shelf are those in rural areas, people who can’t afford doctor visits and others,” Singiser added.
Major Medical Organizations Back the OTC Access
As per the CAI’s assessment, various prominent medical associations such as the American College of Obstetricians and Gynecologists, as well as the American College of Family Physicians, along with numerous other organizations, have thoroughly examined the available evidence and given their approval for over-the-counter (OTC) availability.
The American Medical Association (AMA) gave kudos to the advisory committee vote. The AMA’s president, Jack Resneck Jr., MD, said that “access is one of the most cited reasons why patients do not use oral contraceptives.” The association, he said, “[urged] the FDA to act swiftly to approve over-the-counter access to oral contraceptives without an age restriction.”
The evidence supporting the transition of Opill to an over-the-counter medication was evaluated by two distinct FDAadvisory panels: the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee.
Opill More Effective Compared to Other Forms of Readily Available Contraception
The issue that was brought forth for consideration by regulatory bodies and discussed by advisory committees revolved around the ability of women to properly use birth control without the need for medical guidance. The effective utilization of oral contraceptives, which play a crucial role in preventing pregnancy, hinges upon their consistent consumption at a fixed time daily.
According to information presented to the advisory committees by HRA Pharma, the manufacturer of Opill, even among women who have been prescribed these contraceptives, approximately 15 percent of users still fail to adhere to the regimen by missing three or more doses per month.
Furthermore, HRA Pharma highlighted the fact that making Opill available over the counter would still yield significantly better pregnancy prevention outcomes compared to other non-prescription alternatives like condoms, spermicides, fertility-awareness applications, and the withdrawal method.
The data shared by HRA Pharma during their presentation to the advisory committees underscores that the adoption of Opill results in a pregnancy rate of 4 to 7 percent among women annually. This is in contrast to the 13 to 27 percent pregnancy rates observed among women who opt for other non-prescription methods, as highlighted in the same presentation.
Opill Deemed Safe for Many Women
As indicated in a past document, the FDA had granted its initial approval for the prescription oral contraceptive pill in 1973. This medication comprises the hormone progestin.
“Progestin-only hormonal birth control pills are very safe and are only contraindicated for a small number of conditions, the main one being breast cancer,” said Kristyn Brandi, MD. She is a Darney-Landy Fellow with the American College of Obstetricians and Gynecologists and she is currently practicing in New Jersey.
“I trust my patients to read the back of the box at the pharmacy and know whether or not a medication is appropriate for them,” Brandi adds. “Patients can also still ask doctors or pharmacists for clarification on whether a drug might be contraindicated for them. We already trust patients every day to read and follow instructions on a wide range of over-the-counter medications — including ones that are less safe than hormonal birth control.”
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