HRA Pharma has asked FDA for permission to sell a birth control pill over the counter in the U.S, first of its kind if approved

A pharmaceutical company has applied for the first time to sell birth control pills over the counter in the United States.

The application submitted by HRA Pharma on Monday sets the stage for a high-stakes judgment by health regulators amid legal and political conflicts over women’s reproductive health. The company claims the timing has nothing to do with the recent Supreme Court ruling reversing Roe v. Wade.

Pills containing hormones have been the most popular method of contraception in the United States since the 1960s, with millions of women using them. They have always required a prescription, often so that medical practitioners may screen for diseases that increase the risk of uncommon but potentially fatal blood clots.

The French pharmaceutical company’s application incorporates years of research aimed to persuade the Food and Drug Administration that women can test themselves for these risks and utilize the tablet successfully while remaining safe.

HRA’s chief strategy officer, Frederique Welgryn, stated, “For a medication that has been available for the past 50 years and has been used safely by millions of women, we decided it was time to make it more accessible.”

An FDA approval may occur the next year and would solely apply to HRA’s tablet, which would be marketed under its original brand name, Opill. The business bought the medicine from Pfizer in 2014, although it is not currently sold in the United States.

Advocates for reproductive rights want alternative prescription contraceptives and, eventually, abortion drugs to be sold over the counter.

This possibility of a precedent-setting decision once more throws the FDA under severe political scrutiny.

When it loosened access to abortion medicines late last year, the FDA was attacked by abortion opponents and praised by women’s rights activists. When it approved the over-the-counter use of Plan B emergency contraceptive pill in 2006, the agency encountered similar political pressures.

Numerous conservative organizations emphasize that they are primarily concerned in restricting abortion, and state prohibitions frequently expressly exclude contraception.

Even prior to Monday’s statement, Democratic senators demanded that the FDA expeditiously review any such petitions.

In a March letter, more than 50 members of the House Pro-Choice Caucus urged the FDA to assess applications for over-the-counter birth control pills expeditiously and purely on the basis of facts.

Drugs for pain relief, heartburn, and allergies, among others, have made the transition from behind the pharmacy counter.

In each instance, firms must demonstrate that customers can comprehend the drug’s labeling, assess its risks, and use the medication safely and effectively without expert supervision. HRA spent seven years completing the FDA-required studies, including a trial in which 1,000 women were observed for six months while taking its tablet.

Behind the company’s efforts is a network of women’s health researchers and campaigners who have labored for over two decades to increase access to contraceptives, particularly for populations with limited access to health care.

The Oral Contraceptives Over-the-Counter Working Group funded a portion of HRA’s study and is gathering support for a media campaign called Free the Pill.

Kelly Blanchard, president of Ibis Reproductive Health, a member organization that advocates abortion and contraception access, stated, “Much of our research has focused on making the case to motivate and support a corporation to take on this task.”

Contraceptives are available without a prescription over a large portion of South America, Asia, and Africa. HRA, located in Paris, was granted U.K. permission for the first over-the-counter birth control tablet in 2013.

Advocates were especially interested in HRA’s medicine because, according to them, it is less likely to generate safety issues.

The tablet contains a single hormone, progestin, which prevents pregnancy by preventing sperm from entering the cervix.

The progestin and estrogen found in the majority of birth control pills can help make periods lighter and more regular. Generally, progestin-only pills are recommended for women who cannot use the more common combo pills due to health concerns.

However, estrogen accounts for the majority of the risk of blood clots related with oral contraceptives. Certain women who are already at risk for cardiac problems, such as those over the age of 35 and smokers, are cautioned against using these drugs on the FDA’s labeling.

For the vast majority of women, the medications are extremely safe. According to FDA data, for every 10,000 women taking combo tablets annually, three to nine will develop a blood clot. This contrasts to one to five clots per 10,000 women who do not use contraception.

And medical experts note that the risk of blood clots is significantly increased in pregnant women due to elevated hormone levels and decreased blood flow.

“What I see is a clear misunderstanding of the dangers associated with these drugs. According to Dr. Maura Quinlan, a Northwestern University physician and member of the American College of Obstetricians and Gynecologists, it is more safer to take the pill than to become pregnant. She did not contribute to the HRA application or research.

The medical association supports over-the-counter availability of all hormone-based contraceptives. The American Medical Association, the nation’s largest physician organization, backed over-the-counter birth control pills last month.

However, there is not unanimous approval.

The National Center for Health Research’s Diana Zuckerman argues that comparing the safety hazards of the tablets to those of pregnancy is not the proper method.

According to Zuckerman, whose group assesses medical studies, many women take birth control pills to manage or lessen menstrual flow. She stated, “These are genuine advantages, but they are not worth the risk of potentially fatal blood clots.”

The FDA has examined the safety of oral contraceptives for decades, revising their warnings over time.

A year ago, the government placed a stop on a research conducted by the pharmaceutical company Cadence Health, which has also been developing an over-the-counter medicine. The organization was instructed to conduct additional blood pressure tests on trial participants. According to the corporation, “efforts are being made to overcome this regulatory obstacle.”

Before making a judgment, the FDA must conduct a public meeting to consider HRA’s application. Safety concerns are likely to take precedence.

Perrigo Co.-owned HRA executives anticipate a decision in the first half of 2023.

Advocates have high hopes that it will be the first of many.

Blanchard stated, “Once we see the approval of this medicine, it will establish that it is possible and that the data is solid.” Hopefully, the process will accelerate from here on out.