FDA considers over-the-counter birth control pill for summer approval

The Food and Drug Administration (FDA) could soon approve the sale of birth control medication without a prescription for the first time in the US by this summer. A committee of independent experts will meet to decide whether data submitted by HRA Pharma is sufficient to allow over-the-counter sales of Opill, the company's contraceptive. However, FDA staff have raised concerns that some consumers who should not take norgestrel (the generic name for the drug) did not understand the drug label warning in a study. Women with a history of breast cancer and those with unexplained vaginal bleeding were specifically mentioned as groups who may not understand the label. The FDA also raised concerns that Opill may not be as effective in preventing pregnancy as it was when it was first approved due to increasing rates of obesity and lower adherence to a dosing regimen.

HRA Pharma originally asked the FDA to approve sales of Opill in July 2022, just two weeks after the Supreme Court overturned its own ruling in the case known as Roe v. Wade. The Supreme Court's decision meant there was no longer a right to abortion under the Constitution, triggering a series of legal restrictions on abortion in a number of states, and also led to calls for expanded access to contraceptives and to medication that can end a pregnancy. Medical associations such as the American College of Obstetricians and Gynecologists for years have supported over-the-counter access to birth control without age restrictions. In March 2022, more than 50 members of Congress urged the FDA Commissioner to review applications for over-the-counter sales of birth control without delay.

Despite the concerns raised by FDA staff, HRA Pharma expects an FDA decision on the request in the summer. The company said 97% of 206 participants in a study who had a history of breast cancer understood the drug's label and chose not to use the pill. Six participants incorrectly chose to use norgestrel despite their cancer history, the company said. HRA Pharma said 22 women reported unexplained vaginal bleeding that they had not discussed with a doctor at study enrollment. Seven of these individuals chose to take Opill during the study. One of these participants spoke to a doctor during the study, while six did not. The company said these six individuals did not consult a doctor because their bleeding was not frequent or they considered it to be normal. A panel of doctors viewed norgestrel as appropriate for these women, HRA Pharma said. The failure rate of progestin pills like Opill is low, estimated at about 7% of women who use such contraceptives will have an unintended pregnancy in the first year.


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