The Food and Drug Administration could approve the sale of birth control medication without a prescription for the first time by this summer.
According to CNBC, A committee of independent experts who advise the FDA is set to meet Tuesday and Wednesday to make a recommendation on whether data submitted by HRA Pharma is sufficient to allow over-the-counter sales of Opill, the company’s contraceptive
The FDA is not obligated to follow the advice of its outside experts. But a positive recommendation would weigh heavily in favor of allowing the sale of the pill, known generically as norgestrel, without a prescription.
However, FDA staff has raised concerns that some consumers who should not take norgestrel — or who need to consult their doctor first due to health conditions — did not understand the drug label warning in a study, according to an agency briefing document publicly released Friday.
Despite that, HRA Pharma expects an FDA decision on the request in the summer, according to a spokesperson for the Paris-based drugmaker, which is owned by the consumer health-care company Perrigo
Oral contraceptives first entered the U.S. market more than 60 years ago, and since then have required a doctor’s prescription. The FDA approved prescription sales of HRA Pharma’s birth control pill in 1973.
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. That triggered 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 FDA Commissioner Dr. Robert Califf to review applications for over-the-counter sales of birth control without delay.
“This is a critical issue for reproductive health, rights, and justice,” the lawmakers wrote. “Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system.”
