FDA advisers unanimously support approval of over-the-counter birth control pill
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Key takeaways :
- Two FDA advisory committees voted unanimously to recommend approval of an over-the-counter progestin-only birth control pill.
- Members said data show the pill is safe and effective and benefits outweigh risks.
FDA advisers voted unanimously to recommend approval of an over-the-counter progestin-only birth control pill, a decision hailed by one advisory panel member as a landmark for the history of women’s health.
In a joint meeting of the FDA’s Nonprescription Drugs Advisory Committee and the Obstetrics Reproductive and Urologic Drugs Advisory Committee, members agreed that consumers will be likely to use the norgestrel tablet properly without interacting with a health care professional and that the benefits exceed any risk for nonprescription use.
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“In the balance between benefit and risk, we have a hard time justifying not taking this action,” advisory committee meeting chair Maria C. Coyle, PharmD, FCCP, BCPS, BCACP, CLS, associate clinical professor at Ohio State University College of Pharmacy, said during discussion after the vote. “The benefits are large; the drug is incredibly effective and it will be effective in the over-the-counter realm just as it is in the prescription realm. The populations of greatest concern are already highly engaged in the health care system. The risk of unintended pregnancy, while real, is less than that of other methods of over-the-counter birth control.”
Opill (norgestrel 0.075 mg; HRA Pharma) is a once daily progestin-only oral contraceptive pill to prevent pregnancy. Norgestrel prevents conception by thickening the cervical mucus to inhibit the penetration of sperm and by suppressing or disrupting ovulation, according to meeting briefing documents.
The committee decision was based on data from the Adherence with Continuous-Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study, a single arm, nonrandomized, open label, multicenter 24-week prospective study designed to assess the language and guidance provided by the label instructions for use of an over-the-counter contraceptive pill. Researchers recruited women interested in over-the-counter birth control from 36 U.S. sites to examine if, when and how participants used norgestrel in an over-the-counter environment for 6 months.
In the self-selection phase of the study, 1,772 women who said they would purchase the pill answered health questions, took a health literacy test and underwent a pregnancy test. Overall, 1,597 participants (mean age, 26.2 years) responded positively when asked whether norgestrel was OK or not OK for them to take home that day and initiate after reading the label. After researchers classified selections based on a complete review of responses to all questions, 1,180 participants were classified as selectors of norgestrel. Thirty-six participants indicated they would select norgestrel but were classified by researchers as not appropriate users per the label; only one of these participants may have clinically important risk due to a history of breast cancer, according to meeting briefing documents.
In the use phase, 883 women (mean age, 25.5 years) purchased norgestrel with their own money and used it on their own, recording their use with a time-stamped electronic diary; participants received use reminders every 4 days.
Prior to enrollment, 35.3% of participants were not using any form of birth control. The norgestrel label directs users to take one tablet at the same time every day within a 3-hour window and to use a condom or other barrier method during intercourse over the first 48 hours of use.
Compared with typical over-the-counter prescription use adherence of 85%, participants who took norgestrel demonstrated an adherence of 92.5% over 90,128 days of use. This level of adherence was consistent across subgroups with low health literacy, those aged 12 to 14 years and those aged 15 to 17 years. A total of 84.6% of participants reported taking norgestrel at least 85% of days with consistent performance among the same subgroups.
Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, said that the drug’s sponsor demonstrated that the “single absolute contraindication,” which is for women with a history of or current diagnosis of breast cancer, was well understood, whereas the track record of safety for the 30 years the drug was available by prescription-only is well established.
“It would therefore take a very high bar of concern to justify nonapproval of over-the-counter status, given what we know about this medication,” Espey said after the vote. “My personal experience practicing in a large, rural state like New Mexico for the last 30 years, I see firsthand ... the maternal morbidity and mortality that goes along with an unintended pregnancy. Despite FDA concerns about study design, the overall, very rare and unlikely, harms are outweighed by the tremendous benefits of improved access without any restrictions.”
During discussion before the vote, panel members emphasized the need for an over-the-counter contraceptive pill. They said norgestrel would be safe and effective in the over-counter-setting for the general population, adolescents, those with limited literacy and those using other drugs that might interact with norgestrel — particularly given that users of the prescription product likely receive limited counselling.
“Adolescents really urgently need this,” committee member Leslie R. Walker-Harding, MD, Ford/Morgan Endowed Professor Chair of the department of pediatrics and associate dean at the University of Washington, said. “With 70% of adolescent and reproductive-age women either having no or a lower-efficacy birth control method available to them, this would dramatically increase the ability of kids not having unintended pregnancies.”
Margery Gass, MD, professor of clinical emerita at the University of Cincinnati College of Medicine, called the panel’s recommendation “a landmark for the history of women’s health.”
“Unwanted pregnancies can really derail a women’s life, and especially an adolescent’s life,” Gass said after the vote. “I am very pleased FDA considered this and I look forward to it being on the market.”
The FDA is not required to follow the recommendations of its advisory panels, but it usually does.