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Morning Briefing

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Thursday, Oct 27 2022

Full Issue

FDA Puts Off Decision On OTC Birth Control Pill

A decision on allowing prescription birth control pill Opill to be available over the counter has been pushed back, reports say. A Food and Drug Administration spokesperson told Axios the delay doesn't reflect on any decision it may make. "Period pills" and abortion issues across the country are also in the news.

The FDA has pushed back a decision date on a proposed over-the-counter switch of Perrigo鈥檚 prescription birth control drug Opill by 90 days, Perrigo said Wednesday. Perrigo had previously expected an approval in the first half of 2023, but the exact original FDA action date was never disclosed. Perrigo鈥檚 HRA Pharma applied for the Rx-to-OTC switch on July 11, and such reviews typically take 10 months. In addition to its decision delay, the FDA also postponed a planned joint meeting by its Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee to discuss Perrigo鈥檚 application. The conference was previously scheduled for Nov. 18. No new date has been set, Perrigo said. (Liu, 10/26)

"Protection of women鈥檚 health is of high importance to FDA," an FDA spokesperson told Axios. "The postponement does not indicate or affect any decision regarding the application," the spokesperson said, and added that the agency "remains committed to a timely review of this application." (Gonzalez, 10/26)

Also 鈥

Imagine this situation: A woman misses her period and worries she might be pregnant. She doesn鈥檛 want to be, so she schedules an appointment with a health care provider and tells them she wishes to get her period back. The provider prescribes her a course of 鈥減eriod pills.鈥 She gets her period again, and that鈥檚 the end of it. Such a scenario is not purely hypothetical. Period pills are the same ones used in medication abortion鈥攎isoprostol alone or in combination with mifepristone鈥攚hich could imply that menstrual regulation is just another name for early abortion. But the drugs might not be considered abortion medication because the patient never learns whether they were pregnant in the first place. (Lenharo, 10/26)

In abortion news from Pennsylvania, New Mexico, and Texas 鈥

Abortion providers across Pennsylvania urged the state鈥檚 highest court on Wednesday to overturn a longtime ban on Medicaid funding for the procedure. Planned Parenthood and other providers say the 1982 law violates the state鈥檚 Equal Rights Amendment by treating women鈥檚 health care needs differently than those of men. (Dale, 10/26)

The new frontline of the U.S. abortion battle is on the remote plains of New Mexico, where two conservative towns are set to outlaw the medical procedure despite it remaining legal in the state after Roe v. Wade was struck down. The towns of Clovis and Hobbs do not even have abortion clinics but are strategic, activists and clinicians say, because they are near the border with Texas, to the east. Texas was one of the first states to impose a near-total ban on abortion and providers could face up to life in prison there. (Brooks, 10/26)

The Texas Supreme Court heard arguments Wednesday over whether a defamation case brought by several abortion funds against prominent anti-abortion activist Mark Lee Dickson should be dismissed. (Nguyen, 10/26)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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