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Opill birth control pills

Courtesy of Perrigo Co.

FDA advisers: Benefits of over-the-counter birth control pills outweigh risks

May 10, 2023

Advisers to the Food and Drug Administration (FDA) are calling for a progestin-only birth control pill to be the first available over the counter, saying it would increase access to safe, effective contraception.

The FDA panel voted 17-0 Wednesday in favor of allowing nonprescription use of Opill from Perrigo Co. affiliate HRA Pharma after a day and a half of presentations and discussions. Panelists said the benefits outweigh the risks for all ages.

“I understand that barriers in access to contraceptives are real and very harmful and amplified in adolescents,” said Elise D. Berlan, M.D., M.P.H., FAAP, a member of the AAP Section on Adolescent Health (SOAH) speaking on her own behalf. “ … We should also keep in mind that the health risks of pregnancy, which is the condition these products aim to prevent, is much greater than the use of any contraceptive product.”

However, FDA staff expressed reservations about some of the application data on women using the medication correctly, making it uncertain whether the agency ultimately will approve.

“The FDA has been put in a very difficult position of trying to determine whether it is likely women will use the product safely and effectively in a nonprescription setting,” said Karen Minerve Murry, M.D., deputy director of the FDA’s Office of Nonprescription Drugs. “But I wanted to again emphasize FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women.”

Opill is a daily birth control pill that consists of 0.075 milligrams of norgestrel and was first approved by the FDA in 1973. At the time, data showed the likelihood of becoming pregnant in the first year of prescription use was about 2%. Since then, 17 million packs have been sold in the U.S. The pill’s long history was reassuring to many of the committee members.

“The safety was established 50 years ago when the original approval was made, and the accumulating body of evidence since then shows these pills are safe with very few contraindications,” said Kathryn Curtis, Ph.D., health scientist in the Division of Reproductive Health at the Centers for Disease Control and Prevention.

Discussions among the FDA Nonprescription Drugs Advisory Committee (NDAC) and Obstetrics, Reproductive and Urologic Drugs Advisory Committee largely centered around whether people, especially adolescents and people with low literacy, would use the medication correctly without guidance from a health care provider. They also talked about whether women with certain medical conditions would avoid using it or ask their doctor first.

HRA Pharma presented the panelists with study data showing most people would take the pills at the same time daily as indicated on the label. The company also said its data indicated women would follow the instructions not to use the pills if they have ever had breast cancer and to talk to a doctor if they have a history of other cancers or unexplained vaginal bleeding.

However, the FDA and HRA Pharma had different interpretations of which study participants identified themselves as good candidates for the pills. In addition, 30% of participants filling out electronic diaries on pill use claimed to have taken more pills than they had been dispensed. The FDA said the finding calls into question the integrity of the rest of the data, while HRA Pharma adamantly disagreed. Ultimately the committee members said they still felt they had enough reliable data combined with their own clinical experiences to vote in favor.

“Do I think it was a perfect study? No,” said Cynthia Baur, Ph.D., director of the Horowitz Center for Health Literacy at the University of Maryland School of Public Health. “Do I think it was adequate to feel reassured a large number of people can use this drug as intended? Yes.”

Most panelists said they were not concerned about Opill users not receiving guidance from a health care provider first.

“Talking to an adolescent in an office 20 minutes and then giving them a one-year prescription is really probably about the same as somebody reading it on the label,” said Leslie Walker-Harding, M.D., FSAHM, FAAP, chief academic officer and senior vice president of Seattle Children’s Hospital and a member of SOAH speaking on her own behalf.

Others noted there was no way to know if people were using the product correctly even if they had a prescription. Not taking the pills at the same time daily could increase the risk of unintended pregnancy, but this also didn’t outweigh the benefits for members.

“The risk of unintended pregnancy, while real, is less than that of existing over-the-counter methods of birth control,” said NDAC Chairperson Maria C. Coyle, Pharm.D., associate clinical professor at The Ohio State University College of Pharmacy.

While several members said they had reservations about adolescents and people with low literacy, these were not enough to keep them from recommending over-the-counter use.

“I’m sure it won’t be as effective for them, but it will still be more effective than what’s out there available right now,” said Paul Pisarik, M.D., M.P.H., FAAFP, geriatric physician at Archwell Health.

Across women all ages, data show nearly 3 million pregnancies each year are unintended. Adolescents face numerous challenges to accessing birth control pills, including the need to see a doctor and obtain a prescription. This is difficult for those who don’t have a provider nearby, are unsure if they can access confidential care or may not want the pills covered by their parents’ insurance.

“Access barriers impact adolescents more than anyone else,” said Dr. Berlan, professor of clinical pediatrics at The Ohio State University College of Medicine. “They’re actually healthier than other pregnancy-capable people, and they’re at the highest risk of unintended pregnancy.” She added that she trusts teens to use the pills.

The committee members also discussed questions from the FDA about whether people with breast cancer would opt out of using Opill. They agreed women with breast cancer already are under a doctor’s supervision and very careful about taking medications that could increase their risk of recurrence.

Panelists encouraged FDA approval, noting the impact it would have on health equity.

“We can take this opportunity to increase access, reduce disparities, and most importantly increase the reproductive autonomy of the women of our nation,” said panelist Jolie Haun, Ph.D., Ed.S., supervisory research health scientist at the James A. Haley Veterans’ Hospital.



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