The American Medical Association is urging the FDA to approve OTC access to oral contraceptives.
After the United States Supreme Court overturned it’s the longstanding Roe v. Wade decision on June 24,1 retail pharmacies are experiencing a marked increase in patients looking to purchase Plan B emergency contraception and are placing limits on the medication.
Meanwhile, the American Medical Association (AMA) is encouraging the FDA to approve OTC access to oral contraceptives without an age restriction.
On Monday, CVS Health, Walmart, and Rite Aid began limiting purchases of the Plan B bills, which were out of stock or in short supply on their web sites, according to The Wall Street Journal.2
Although Walgreens does not have purchase limits in place currently, Fraser Engerman, senior director of external relations for the chain, told Drug Topics®, the retailer is “working to restock online inventory for ship-to-home.”
“Walgreens is still able to meet demand in-store, including leveraging digital-first solutions like curbside pickup. Plan B is being shipped to our stores and also restocked online in the next day or 2,” Engerman added.
A CVS spokesman told The Wall Street Journal the company has implemented temporary purchase limits to ensure equitable access, but it has ample supply of the pills in stores and online.
And according to Catherine Carr, manager of public relations and external communications at Rite Aid, “Due to increased demand, at this time we are limiting purchases of Plan B contraceptive pills to 3 per customer.”
Walmart did not respond to the publication’s requests for comment.
Meanwhile, the AMA’s new policy, adopted the policy at its 2022 Annual Meeting of the AMA House of Delegates in Chicago, June 10 to 15, is particularly timely given the Roe v. Wade ruling.
“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,” said AMA Board Member David H. Aizuss, MD, in a news release.3 “Access is one of the most cited reasons why patients do not use oral contraceptives, use them inconsistently, or discontinue use. Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”
There is a regulatory pathway 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, AMA said.
When considering manufacturer applications, the FDA should consider that OTC birth control pills are safe and “a common-sense, science-based approach to addressing an important health equity and reproductive justice issue facing our communities,” the OCs OTC Working Group said in a recent letter4 to FDA Commissioner Robert Califf, MD.
“Over 60 years of research and data show that oral contraception is safe and effective. However, due to pervasive and systemic inequities, significant barriers to access remain for communities who bear the greatest share of these inequities: people of color, particularly Black, Latinx, AAPI, and Indigenous peoples, people who live in rural areas, those working to make ends meet, immigrSants, LGBTQ+ folks, and young people,” the Working Group wrote. "Increasing access to over-the-counter birth control would allow people to make decisions with dignity and respect—about their own bodies, lives and reproductive health and well-being, including when and whether to have children.”
Although the National Community Pharmacists Association (NCPA) does not have an established position on the issue currently, “we expect to have more insight after the NCPA House of Delegates meets during our annual convention in October to install new officers and consider legislative, regulatory, or policy resolutions,” Andrea Pivarunas, director of public affairs for NCPA, told Drug Topics®.
“We anticipate discussions among delegates around options that would support patients having the choice to access oral contraceptives at pharmacies while also having a healthcare provider readily available to consult with on subjects including possible drug interactions, choosing between the dozens of oral contraceptives available in the marketplace, and their uses beyond contraception (acne, headaches, etc.),” she added.
Representatives from the American Pharmacists Association and the National Association of Chain Drug Stores did not respond to requests for comment.
Meanwhile, the AMA “will work with expert stakeholders to advocate for the availability of hormonal contraception as an OTC medication and continue to study issues relevant to OTC access including full insurance coverage without cost sharing of an OTC oral contraceptive,” the organization said.
Originally published on our sister brand, Drug Topics.