Pharmaceutical

French Pharmaceutical Co. Applies to Sell OTC Birth Control In US

The Food and Drug Administration might accept an application from a French pharmaceutical business that intends to make birth control pills offered without a physician’s prescription.

The application from HRA Pharma would certainly be the initial of its kind in the United States.

“We’re very proud of being the first company to submit the first-ever application to the FDA for daily birth control over the counter, and obviously it’s coming at the right moment,”  Frédérique Welgryn, the company’s chief strategic operations and innovation officer, said in a July 11 statement.

“More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant,” added Welgryn. “Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”

HRA Pharma has asked the FDA to relocate its once-daily progestin contraceptive pill Opill from prescription pharmaceutical classification to an OTC product that women can access without requiring to get in touch with a medical professional.

The business claims over 6.1 million unintended maternities occur annually in America which raising accessibility to and offered approaches of birth control “will increase the likelihood of using effective birth control methods.”

“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,” stated HRA.

The FDA first authorized Opill for prescription use in 1973.

Medical companies, including the American University of Obstetricians and Gynecologists and also the American Medical Association, have actually called for the non-prescription contraceptive pill to be made available to customers.

“A regulatory pathway exists at the FDA for converting oral contraceptives from prescription products to OTC products and a required manufacturer application for a switch is expected to be submitted before the end of 2022,” the American Medical Association said in a press release in June.

“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” added Dr. David Aizuss, a board member of the organization. “Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”

Contraceptive pills have been one of the most commonly owned form of contraception since they were at first accepted by the FDA in the 1960s.

According to data from the Centers for Disease Control and Prevention, 14% of ladies between the ages of 15-19 make use of the contraceptive pill as a type of birth control. Concerning 10% use a long-acting reversible birth control such as an intrauterine device.

The Kaiser Family Foundation, a national wellness concerns not-for-profit, records that “White women are more likely to use Oral Contraceptive Pills than Hispanic or Black women” and that  “OCP use increases with higher educational attainment.”

While HRA Pharma’s application came weeks after the Supreme Court reversed government protections for abortion, the pharmaceutical firm has actually been servicing offering a non-prescription contraceptive pill for almost six years. In December of 2016, HRA Pharma as well as Ibis Reproductive Wellness revealed they would partner to “conduct the research needed” to make an application for an Rx-to-OTC switch with the FDA.

“This is an exciting step forward in our work to increase access to reproductive health care and improve women’s ability to access safe and effective contraceptive methods,” Ibis Reproductive Heath said in a press release at the time. “Too many people in the United States face barriers to accessing the contraceptive methods they want; a safe and effective hormonal birth control pill available over the counter would improve access and help people overcome some of those barriers.”

In 2019, Republicans in the Senate introduced a law to accelerate the authorization procedure for pharmaceutical makers relating to having their hormone birth controls made into OTC products.

Senator Joni Ernst of Iowa and Legislator Cory Gardner of Colorado introduced the Allowing Greater Access to Safe and Effective Contraception Act which would certainly have needed the Health and wellness and also Health and Human Services Secretary to offer top priority to applications for appropriate drugs. The lawmakers also wanted to finish the tax obligation on over-the-counter medications.

H/T Timcast

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