FDA delays key advisory committee meeting on OTC birth control
Two panels were originally scheduled to jointly meet Nov. 18 to discuss an application for a progestin-only birth control pill
The Food and Drug Administration on Wednesday postponed a critical advisory meeting on an application for the nation’s first over-the-counter birth control pill, citing the need “to review new information.”
The Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee were set to jointly meet Nov. 18 to discuss the application from HRA Pharma, an affiliate of Perrigo Company, for its progestin-only birth control, Opill. The FDA typically follows the committees’ recommendations in making a final decision.
A new date has not yet been set. The FDA also extended its timeline for a final decision by 90 days.
“The Company will continue to work collaboratively with the FDA to ensure a timely and thorough review,” Perrigo said in a statement.
A spokesperson for Perrigo declined to elaborate on the new data or the final decision deadline. The company filed its application in July.
Democrats are increasingly agitating to expand access to birth control in the wake of the June 24 Supreme Court decision overturning the Roe v. Wade opinion granting a constitutional right to abortion. Planned Parenthood said after that decision that its affiliates experienced a 150 percent increase in calls for birth control appointments.
The House Oversight and Reform Committee released a report Tuesday highlighting barriers some patients face in accessing certain types of birth control.
The 2010 health care law requires most insurers to cover at least one birth control product in each category with no cost-sharing. In July, the Health and Human Services, Treasury and Labor departments released guidance saying plans must provide any method of birth control for free if the patient’s provider recommends it. The Department of Veterans Affairs recently proposed removing cost-sharing requirements for contraception under its health care system, in a rule designed in part to better align coverage with the military program, TRICARE.
The committee found that patients still often face copays, including for at least six products with no market equivalent. That includes the Twirla patch, which can cost as much as $178 per month, while some pills can cost as much as $218 per month.
Democrats are now calling on the Biden administration to further strengthen guidance related to birth control access.
“In the wake of the extreme Supreme Court decision to overturn Roe v. Wade, the ability to decide if and when to become pregnant has never been more important,” House Oversight Chairwoman Carolyn B. Maloney, D-N.Y., said in a statement.
Democrats have pressured the administration to act on expanding and protecting the right to contraception since the Dobbs v. Jackson Women’s Health Organization ruling. The 1973 Roe v. Wade ruling cited Griswold v. Connecticut, a landmark 1965 privacy decision related to the right for married couples to use birth control.
In July, the House passed its contraception rights bill by a vote of 228-195, with eight Republicans joining 220 Democrats.
Advocates for birth control are likewise upping the pressure. Ibis Reproductive Health, which runs the “Free the Pill” campaign, said it was “frustrated and deeply disappointed” in the FDA’s delay.
“Increasing access to birth control by removing the prescription requirement is a public health priority, and now more than ever, we need to increase access to the contraception people want and need,” the group said in a statement.