Scientists at the Food and Drug Administration expressed skepticism Friday about whether the birth control pill can be switched from prescription to over-the-counter.
The evaluation by FDA staff, included in information documents Released Friday, it comes ahead of a two-day meeting scheduled for next week, when agency advisers will vote on whether to recommend that the agency allow a birth control pill called Opill to be sold without a prescription.
If advisers recommend it and the FDA approves Opill for over-the-counter use, it would be the first time the pill could be sold without a prescription. HRA Pharma, which makes Opill, hopes the agency can make a final decision by late summer.
Whether women can follow the package label instructions and take the drug correctly seemed a top concern for FDA scientists, who doubted the pill’s maker had provided enough data.
Birth control pills must be taken at the same time every day. Failure to do so could lead to an unwanted pregnancy, the agency scientists wrote. But skipping doses is not uncommon: studies have shown that approximately half of women report missing a dose at least once a month.
fda approved Opill for prescription use in 1973. As part of the company’s application for non-prescription use, the agency requested additional information on the drug’s efficacy in the current population.
However, the updated analysis provided by the company fell short, the FDA scientists said, noting that it was based on low-quality studies, many of which dated back to the 1960s and 1970s.
FDA staff also questioned the findings of another study, called Access, in which researchers tested whether participants took the drug as directed on the label. The study found that about 97% of the time, participants reported taking the medication correctly or following the label directions if they missed a dose.
However, the agency said it found that «a substantial portion» of participants either overreported the number of pills they took or reported taking more pills than were dispensed, factors that «question the reliability of all usage data.» real».
A push for greater access to birth control
In a statement issued in response to the FDA briefing documents, a spokesperson for Perrigo, which owns HRA Pharma, said Opill is safe and effective for use without a prescription.
“Daily birth control was approved more than 60 years ago, and progestin-only pills have a long history as a safe and effective method of preventing pregnancy,” the spokesperson said. «We look forward to presenting our data and having a meaningful discussion on these issues on May 9 and 10.»
The push for easier access to birth control comes amid a changing political landscape for women’s reproductive rights.
Last June, the Supreme Court struck down the landmark Roe v. Wade that guaranteed the constitutional right to abortion. In April, the Supreme Court rejected a lower court decision to issue a nationwide injunction on the drug mifepristone, one of two drugs used in medical abortions. That case is still making its way through the lower courts, and the 5th Circuit is scheduled to hear oral arguments on May 17.
HRA Pharma is petitioning the FDA to approve the over-the-counter birth control pill for all women of reproductive age.
Making the pill available without an age restriction could be especially important for teens and younger adults who often face many barriers to accessing health care and getting birth control prescriptions, said Dr. Kristyn Brandi. , Fellow of the American College of Obstetricians and Gynecologists. . Among girls ages 15 to 17 in the United States, 72% of pregnancies were unintended, according to data provided by the FDA.
Other contraceptives, such as condoms, involve the active participation of the woman’s partner.
Brandi declined to comment on the FDA’s conclusions in the briefing documents.
In Friday’s filings, the FDA noted that in a prescription setting, progestin-only drugs have been shown to be safe. The agency noted there is a risk of breast cancer and undiagnosed vaginal bleeding, and said it planned to ask advisory committees next week if they think consumers will be able to assess those safety risks for themselves. (These risks are common among hormonal birth control drugs.)
Agency staff also noted that there was a lack of information about use in adolescents and whether they could follow label directions.