FDA advisory panels back over-the-counter sales of birth control pills

WASHINGTON (OSV News) — A panel of federal advisers voted May 10 in favor of a pharmaceutical company’s request to sell a type of their birth control pills over the counter and without a doctor’s prescription, clearing the way for the Food and Drug Administration to approve such sales of oral contraception.

Currently, a woman seeking to use birth control pills must do so with a doctor’s prescription. But in a unanimous vote following a two-day joint meeting of two FDA advisory committees, the federal advisers offered their support to selling the company Perrigo’s product, Opill, without a prescription. The vote will likely pave the way for the agency to approve the sale of birth control pills over the counter, which will impact ongoing debates about abortion policy post-Roe.

While some have called for expanded access to contraception in the wake of the Supreme Court’s reversal of Roe v. Wade last year, others have argued that their misuse without medical supervision could cause more unintended pregnancies.

In a guide about the church’s teaching on issues including contraception, the National Catholic Bioethics Center describes contraception as “any action that is specifically intended, whether as an end or as a means, to prevent procreation either before, at the moment of, or after sexual intercourse.”

While contraception “is never to be directly intended,” its use for “therapeutic means needed to cure diseases is not illicit, even if it results in a foreseeable impediment to procreation — provided the impediment is not directly intended for any motive whatsoever.”

The federal advisers found that the benefits outweigh the risks of over-the-counter birth control pills, finding that users do not need the consultation of a medical professional to follow instructions for their use, like taking the pill at the same time every day. According to the FDA’s website, risks associated with oral contraception can include spotting or bleeding between periods, nausea and headaches.

The pharmaceutical company behind Opill praised the panels’ support of selling the drug without a prescription.

“Today’s vote to recommend a switch of Opill® to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray S. Kessler, the company’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception. Today’s outcome reflects Perrigo’s steadfast commitment to women and people, and their health.”

Frederique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that “Today’s vote reflects the strong data showing that Opill® can be used safely and effectively over-the-counter.”

“FDA’s approval of Opill® for over-the-counter use would address a key unmet need for contraceptive access, be a groundbreaking expansion for women’s health nationwide and a step forward toward ensuring people can have improved access to contraception without unnecessary barriers,” Welgryn said.

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