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.
FiercePharma:
OTC Birth Control Pill Delayed As FDA Postpones Expert Meeting For Perrigo Drug
The FDA has pushed back a decision date on a proposed over-the-counter switch of Perrigo’s 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’s 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’s application. The conference was previously scheduled for Nov. 18. No new date has been set, Perrigo said. (Liu, 10/26)
Axios:
FDA Postpones Meeting To Review Over-The-Counter Birth Control Pills
"Protection of women’s 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 —
Scientific American:
These Drugs Could Restore A Period Before Pregnancy Is Confirmed
Imagine this situation: A woman misses her period and worries she might be pregnant. She doesn’t 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 “period pills.” She gets her period again, and that’s the end of it. Such a scenario is not purely hypothetical. Period pills are the same ones used in medication abortion—misoprostol alone or in combination with mifepristone—which 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 —
AP:
Abortion Providers Challenge Medicaid Ban In Pennsylvania
Abortion providers across Pennsylvania urged the state’s 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’s Equal Rights Amendment by treating women’s health care needs differently than those of men. (Dale, 10/26)
Reuters:
New Frontline Of U.S. Abortion Battles Emerges In New Mexico
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 Tribune:
Texas Supreme Court To Rule In Defamation Case Against Anti-Abortion Activist
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)