Company seeks FDA approval for OTC birth control pill

Since the Sixties, tens of millions of Americans have used hormone-based drugs to forestall being pregnant, making every day contraceptive drugs one of many most common forms of birth control within the nation, in response to the U.S. Centers for Disease Control and Prevention (CDC). 

In June, the Supreme Court overturned Roe v. Wade, the landmark case that federally protected the correct to an abortion. In the opinion, Justice Clarence Thomas wrote that the Court also needs to rethink different rulings, together with Griswold v. Connecticut, which protects the freedom of married {couples} to purchase and use contraceptives with out authorities restriction. In many countries exterior of the U.S., birth control drugs can be found over-the-counter, however current on-line searches present (here, here and here) that many individuals are questioning if they’ll get every day contraceptive drugs within the U.S. with no prescription.  

Is an over-the-counter every day birth control pill at the moment obtainable within the U.S.?

No, an over-the-counter every day birth control pill shouldn’t be at the moment obtainable within the U.S. 

On July 11, pharmaceutical firm HRA Pharma submitted an software to the FDA to modify Opill, a progestin-only every day birth control pill, from prescription to over-the-counter. If authorised, it could be the primary every day birth control pill obtainable with no prescription within the U.S.

An over-the-counter (OTC) every day birth control pill shouldn’t be at the moment obtainable within the United States. According to the U.S. Food and Drug Administration (FDA), all OTC medications should meet FDA high quality, effectiveness and security requirements previous to receiving the company’s approval. 

The FDA lists obtainable birth control options in the united stateson its web site. Combination oral contraceptives (drugs that include two hormones, estrogen and progestin, to cease the ovaries from releasing eggs; generally often called “the pill”) and the “mini pill,” a progestin-only oral contraceptive, each want a prescription from a healthcare supplier, in response to the FDA. 

Other short-acting hormonal birth control strategies, together with the patch and the vaginal contraceptive ring, additionally want prescriptions. Hormone-based birth control drugs have at all times required a prescription within the U.S., normally so well being care suppliers can display screen for circumstances that elevate the danger of uncommon, however harmful, blood clots. 

The “morning-after” emergency contraceptive pill, also referred to as Plan B, is available in the U.S. over-the-counter without a prescription. Plan B shouldn’t be a every day contraceptive however as an alternative, a two-dose routine meant to be taken after sexual exercise.

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On July 11, HRA Pharma, a pharmaceutical firm primarily based in France, submitted its application for a prescription to OTC swap for Opill, a progestin-only every day birth control pill (also referred to as a mini pill or non-estrogen pill) to the FDA. Opill has been used to forestall being pregnant within the U.S. because it was authorised by the FDA in 1973, HRA Pharma stated in a press release. If authorised, it could be the primary every day birth control pill obtainable OTC with no prescription within the U.S.

“Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for contraceptive pill, patch, or ring reported difficulties doing so,” HRA Pharma stated, citing a 2016 study. “Removing the prescription requirement with Opill would improve access to a contraceptive method that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC.” 

Most birth control drugs include progestin plus estrogen, which may help make durations lighter and extra common, however estrogen additionally accounts for many of the blood clot threat related to oral contraceptives. The FDA’s labeling warns in opposition to their use in sure girls already in danger for coronary heart issues, reminiscent of those that smoke and are over 35.

Progestin-only drugs, like Opill, are usually really helpful for girls who can’t take the extra in style mixture drugs on account of well being points. OTC birth control pill advocates have been notably thinking about Opill as a result of they are saying it is prone to elevate fewer security issues. 

RELATED: No, well being knowledge from most period-tracking apps shouldn’t be protected underneath HIPAA

Over 100 international locations at the moment present birth control drugs OTC with no prescription, in response to a 2012 study carried out by Ibis Reproductive Health, a world analysis and advocacy group. Ibis has led a coalition-driven effort, often called “Free the Pill,” to deliver the birth control pill over-the-counter within the U.S. for almost 20 years. 

In a press release, Ibis stated the group and its coalition companions carried out vital analysis and constructed consensus on the necessity for an over-the-counter birth control pill for a decade. Ibis says it partnered with HRA Pharma in 2016 to conduct the analysis wanted to submit its software to the FDA. 

“Ibis Reproductive Health celebrates this important milestone and looks forward to continuing to work with coalition members to ensure that future OTC birth control pills are affordable, fully covered by insurance, and accessible to people of all ages in the United States,” Ibis wrote.  

Cadence Health, one other firm that has been engaged on an OTC birth control pill for a number of years, says it has plans to submit its personal software to the FDA for Zena, an oral mixed contraceptive pill. In early 2021, the FDA positioned a maintain on a medical examine by Cadence Health, telling the corporate to conduct extra blood strain checks of trial members. Cadence Health instructed VERIFY it’s “actively working to overcome this regulatory hurdle by developing an easy-to-use technology interface for our OTC product.” 

“We have conducted more than 30 studies with more than 3,000 women simply to determine that women are able to understand the contraindications and follow the instructions, as there are some women who should not take the birth control pill,” Cadence Health stated. “We were ready to begin the final step, the Actual Use Trial, when the FDA placed the study on hold. We are now working diligently to overcome this regulatory hurdle. Of note, there is more than 25 years of safety data on this particular pill.” 

RELATED: VERIFY Fact Sheet: Where abortion is authorized, and the place it’s not

Several main medical associations, together with the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians, all help shifting birth control drugs over-the-counter. In March, greater than 50 members of Congress sent a letter to FDA Commissioner Robert M. Califf, M.D., expressing their help for OTC birth control drugs. 

“We urge FDA to review applications for over-the-counter birth control pills without delay and based solely on the data and defend against political interference during the review processes. The health and well-being of people capable of pregnancy across America is at stake,” the congressmembers wrote. 

The FDA is required to carry a public assembly to guage HRA Pharma’s software earlier than making a call. Executives at HRA count on a call within the first half of 2023.

VERIFY reached out to the FDA for remark however didn’t hear again by the point of publication. 

The Associated Press contributed to this report. 

More from VERIFY: No, the Supreme Court’s resolution to overturn Roe v. Wade doesn’t ban birth control