For the first time in the US, a pharmaceutical company has requested permission to sell birth control pills without a prescription.
The announcement was made only weeks after the Supreme Court struck down the constitutional right to abortion.
HRA Pharma, a company headquartered in Paris, claims that its application to the Food and Drug Administration is unrelated.
Pills, the most frequent type of contraception in the United States, have been prescription-only for decades.
Studies indicate that more than half of the nearly 6,1 million pregnancies that occur annually in the United States are unplanned. Even though birth control pills were initially licensed for use in the United States more than 60 years ago, around one-third of American women who have sought to get or fill prescriptions have reported encountering difficulty.
Globally, more than 100 countries offer oral contraceptives without a prescription, making the United States one of the few that does. Several prominent US pharmaceutical organizations, including the American Medical Association and the American Academy of Family Physicians, have urged US authorities to follow suit.
HRA Pharma’s Chief Strategic Operations and Innovation Officer, Frédérique Welgryn, stated that the company’s application represented a “watershed moment” for reproductive equity in the United States. According to the business, the application is the result of years of research meant to help make its case to US regulators.
“Making a safe and effective birth control pill available without a prescription would assist more women and people gain access to contraception without encountering unnecessary roadblocks.”
The business anticipates a decision from the FDA within the next year. Approval would only apply to the company’s Opill medication, which was bought from Pfizer in 2014. If prescribed, patients have been able to utilize the tablet since 1973.
The FDA is being urged by Democratic legislators and pro-choice groups to accept petitions similar to HRA’s.
In March, for instance, 50 members of the Pro-Choice Caucus of the House of Representatives published an open letter urging the administration to “evaluate applications for over-the-counter birth control tablets without delay and purely based on the data.”
Ms. Welgryn told the New York Times that the company’s application was unrelated and a “very unfortunate accident.” She stated, “Birth control is not a solution for abortion access.”
Since the Supreme Court’s verdict on abortion, many US shops have reported restricting birth control pills due to increased demand.
Also on Monday, the administration of US President Joe Biden stated that healthcare providers must give abortion services if a mother’s life is in danger.
The administration stated that federal principles for emergency care supersede state laws that now prohibit surgery.
The Department of Health and Human Services stated that physicians are required to perform abortions if they consider a “pregnant patient” is having an emergency medical situation and the procedure would be a “stabilizing treatment.
It was stated that emergencies included “ectopic pregnancy, problems of pregnancy loss, or emergent hypertensive illnesses such preeclampsia with severe characteristics.”
