Birth Control
Sonya Collins
French pharmaceutical company HRA Pharma has applied for FDA approval of what could be the first OTC oral contraceptive in the United States. An OTC birth control pill would increase access to contraception at a time when reproductive rights are under threat. The company filed for the Rx-to-OTC switch less than 3 weeks after the United States Supreme Court overturned Roe v Wade.
“Over-the-counter birth control is available globally,” said Jenni Villavicencio, MD, an OBGYN and family planning specialist and lead for equity transformation at the American College of Obstetrics and Gynecology (ACOG). “So we know that it’s safe and increases access.” The United States is one of few peer states that doesn’t offer it, said Villavicencio.
Opill
HRA Pharma’s FDA application is for an Rx-to-OTC switch for Opill, a progestin-only birth control pill, also known as a minipill or a nonestrogen pill. The daily oral contraceptive contains 75 micrograms of norgestrel. After it earned FDA approval as a prescription drug in 1973, it was sold by Pfizer for many years, but it has not been available in the United States for more than a decade.
Expanding access
Sally Rafie, PharmD, said simply adding another birth control pill to the market brings benefits. “This would be an additional progestin-only pill and just having more options improves access. Making it available over the counter would expand access even more,” said Rafie, founder of The Birth Control Pharmacist.
ACOG, the American Medical Association, and at least 50 members of Congress support OTC access to oral contraceptives. A 2018 survey in Women’s Health Issues found that nearly 1 in 4 teens and adults who were not currently taking an oral contraceptive said that they would if it were available over the counter.
If approved, Opill will eliminate the barrier of attending a medical appointment to get birth control pills. This could make the pills a more feasible option for those who lack health insurance or who face other barriers to keeping medical appointments—provided the pills are affordable.
While HRA Pharma has not released specific information on the expected out-of-pocket cost of its oral contraceptive, Frederique Welgryn, Chief Strategic Operations & Innovation Officer for the company, said in a statement, “We are committed to making Opill affordable for all those who need it. We will set an acceptable price tested with consumers. We’re also working on a program that would offer financial assistance to access the product.”
To ensure equitable access to birth control, some advocates have noted, combination pills would need to be available OTC as well. Proponents have also called for advocacy to insist that insurers cover these nonprescription options.
Proven safety
Progestin-only birth control pills are safer than the more commonly prescribed combined hormonal contraception, Rafie said.
“Combination pills have been the go-to method historically in the U.S., but there’s no real reason for that. Minipills are safer,” she said. “It’s the estrogen in the combined products that has all the contraindications. That’s when you start to worry about blood clots. There really are almost no contraindications to using a minipill.”
Opill, like other progestin-only pills, must be taken at the same time every day in order to ensure efficacy. According to the package insert, women must use a backup form of contraception for 48 hours if they take a pill more than 3 hours late. This window is tighter than the 12-hour window for missing a combined hormonal contraceptive pill.
Studies, as well as years of experience in other countries that offer OTC oral contraceptives, show that women can accurately assess whether a birth control pill would be contraindicated for them and that they can take it correctly to ensure efficacy.
“At some point,” Rafie said, “we have to just trust that people can read and understand the materials. Just because a physician or pharmacist tells them how to take it, that doesn’t necessarily mean they are going to heed that either.”
The availability of an OTC birth control pill would not eliminate the role the pharmacist could play in counseling patients on correct use. An initial purchase of the pills could require consultation with a pharmacist, according to a commentary in the BMJ.
Regardless, said ACOG’s Villavicencio, “Community pharmacists are the first line of interaction. Just because something goes OTC doesn’t mean patients won’t ask questions and need guidance. It’s just taking away some of the gatekeeping of birth control that is unnecessary from a safety and prevention perspective.” ■