CVS and Walgreens, the two largest pharmacy chains in the United States, totaling nearly 18,000 locations nationwide, announced plans on Wednesday to carry the abortion medication mifepristone after the US Federal Drug Administration (FDA) relaxed rules for distributing the pill earlier this week.

The new rule updates FDA labeling to allow any pharmacy that undergoes FDA certification – from independent local stores, to national chains, to telehealth providers – to distribute the abortion pill to patients with a prescription. Since its approval for public use in 2000, mifepristone has been gated behind restrictions limiting its dispensing to a limited number of specially certified doctors and clinics. 

The FDA decision comes as the US continues to grapple with the fallout of the June ruling by the conservative-majority Supreme Court to revoke the federally-guaranteed right to abortion that had stood since the Court’s 1973 ruling on Roe versus Wade. Since the ruling, 12 states have banned abortion beginning from conception. 

The FDA rule does not supersede state laws, meaning its effect will be limited to states that already allow the pill’s use. Walgreens, in its announcement, stressed its distribution of the abortion medication will be “consistent with state and federal laws,” while CVS spokesperson Amy Thibault told USA Today that the company plans to provide mifepristone “where legally permissible.”

Expanding access in the post-Roe era 

Despite state-level limitations on the sale of mifepristone, the net result will be to make the medication more widely available for women in states where sales are permitted. The reduced barriers to accessing the drug may also make it easier for women in the 12 states where abortion bans are in place to cross state lines in order to buy the pills legally with a prescription at a pharmacy. 

The pill can be administered in the first 70 days (up to ten weeks) of pregnancy to stop the production of hormones that maintain the interior of the uterus. It is typically used in combination with misoprostol, which then induces muscle contractions that clear the uterus. Misoprostol has never been tightly regulated due to its use in treating a variety of other medical conditions.

Abortion pills are now the most common method of pregnancy termination in the United States, used in more than half of abortion cases in 2020. Following the overturning of Roe v. Wade last year, the medication is in even higher demand, and has become a focal point of the new front of the American abortion wars. 

The FDA decision is the latest in a series of administrative actions by the Biden administration to reduce barriers to accessing abortion services amid pressure from rights groups to shore-up federal protections for women’s bodily autonomy in the post-Roe era. 

The FDA first issued a temporary suspension of the in-person requirement for prescribing mifepristone during the Covid-19 pandemic in response to a lawsuit led by the American Civil Liberties Union (ACLU) – a change made permanent in December 2021. 

With Tuesday’s decision, the last remaining federal requirements to access the abortion pill are a certification process for health providers and their staff, and a consent form that patients complete to acknowledge they are taking the medication for the purpose of having an abortion.

A “common sense decision”

Leading medical associations, rights groups, and the manufacturers of mifepristone’s brand-name and generic versions welcomed the FDA’s loosening of restrictions as long overdue.

Mifepristone has been used by more than 3.7 million people since the FDA approved the medication over 20 years ago, and while bleeding is a common side-effect, serious complications are exceedingly rare.

“Now, people in states where abortion is legal will be able to get medication abortion with a prescription through their local pharmacy or by mail—just like they can for other equally safe medications,” said Nancy Northup, president and CEO of the Center for Reproductive Rights, in a statement. “This is a commonsense decision that prioritizes science and safety over politics.”

Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, called the move “an important step forward in securing access to medication abortion,” saying the group has long advocated for the in-person dispensing requirement to be removed. 

“There is no clinical evidence that in-person dispensing improves the safety of this medication’s outcomes,” she said. “Instead, this requirement unnecessarily restricted patient access to a safe and effective medication.”

Rule change “will not provide equal access to all people”

Mifepristone has been a focus of regulatory fights between pro-choice and anti-abortion rights groups ever since its approval in 2000, and its newfound centrality to the national abortion access picture is likely to trigger an array of lawsuits from state officials and activist organizations seeking to challenge the FDA’s ruling. 

“Twelve states have banned abortion, and this move will not change anything for the people in those states,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement. “With abortion under attack in so many parts of the U.S., improving access to care is a public health imperative that can’t wait.”

Among the 12 states that ban most or all abortions, many have included specific provisions targeting mifepristone, including the criminal penalties for medical providers who prescribe the pill to patients. 

Evan Masingill, CEO of GenBioPro, the company which manufacturers the generic version of mifepristone, told Politico that while the FDA’s move was “a step in the right direction” to increase access to abortion care, the policy “will not provide equal access to all people.”

“These are medications that have been lawful for a long time. And it isn’t a question as to whether they’re safe and efficacious. It’s really just the politics,” Nicole Huberfeld, a health law professor at Boston University’s School of Public Health told Vice News. 

Larger companies will take longer to adjust to regulatory requirements 

The first officially approved pharmacy under the new requirements to dispense abortion pills, HoneyBee Health, a telehealth provider based in California, began operating on Wednesday, just one day after the ruling. 

The speed of approval bodes well for small-scale operations like HoneyBee, but the sheer size of national chains like Walgreens and CVS means compliance is likely to take months. As a result, first adopters are likely to be independent pharmacies, physicians, and small- to medium-scale health and telehealth providers.  

A spokesperson for Danco, the company that manufactures the branded version of mifepristone known as Mifeprex, told the New York Times the biggest hurdle is likely to be the implementation of privacy rules that require pharmacies to keep the names of health providers and doctors prescribing mifepristone confidential to prevent retaliation from anti-abortion groups. 

In the polarized and increasingly violent arena of US abortion politics, non-compliance with confidentiality rules could have violent real-world consequences. According to the National Abortion Federation’s 2021 Violence and Disruption Report, bomb threats against abortion clinics jumped 80% from their 2020 levels, and a 54% increase in vandalism at facilities providing the procedure. 

Image Credits: Ajay Suresh, Matt Hrkac, Yuchacz, Guttmacher Institute, Anthony.