Republican senators ask HHS and FDA to suspend distribution of abortion drug

It’s been over three years since the U.S. Supreme Court reversed Roe v. Wade and ruled that the Constitution does not protect the right to abortion. In that time, anti-abortion activists and lawmakers have continued efforts to restrict access to abortion through lawsuits, laws that remove and restrict funding for reproductive health, and, most recently, a demand  to stop distribution of the abortion drug mifepristone and suspend the approval of any new generic versions. 

A letter published on Oct. 9 and signed by every Republican senator except Susan Collins of Maine and Lisa Murkowski of Alaska recommends that Health and Human Services Secretary Robert F. Kennedy Jr. and Martin Makary, the commissioner of the Food and Drug Administration, suspend the FDA’s approval of a new generic version of the abortion pill mifepristone, suspend the distribution of all forms of the drug “as an ‘imminent hazard'” under the Federal Food, Drug, and Cosmetic Act, and reinstate the prohibition against clinicians prescribing and dispensing the drug through telehealth services. 

“The ‘abortion-on-demand’ culture enabled by the Biden-Harris administration’s removal of critical safeguards on the only FDA-approved abortion regimen is currently the biggest threat to unborn life in America today,” the letter says. “Under current FDA regulations, these drugs can be obtained via mail order without meaningful consultation with a medical professional and without any confirmation of who is purchasing them or for what purpose.” 

Mifepristone was approved by the FDA 25 years ago and offers a safe, accessible, and more private option to surgical abortion. 

According to the Guttmacher Institute, in 2023, medication abortion, most commonly in the form of a two-pill regimen of mifepristone followed by misoprostol, accounted for 63% of all abortions provided within the U.S. health care system. Guttmacher notes that regulation changes finalized in January 2023 made it possible for patients to obtain the medication through the mail, without an in-person appointment, broadly increasing access, including in states where abortion is banned. 

The recent approval of a new generic version of mifepristone has caused outrage among those in the anti-abortion movement. 

“There is no question in my mind that, like all of these efforts … the ultimate goal is to ban abortion everywhere, for everyone, and for every reason,” Katie O’Connor, director of federal abortion policy at the National Women’s Law Center, told the American Independent. “For the rest of the senators who were supporting this move, and the anti-abortion movement more generally, overturning Roe v. Wade was always just the first step. It was always about criminalizing abortion nationwide, and sending it back to the states was just a sort of soft landing for them before the next step.” 

Mifepristone remains accessible in all 50 states, even those with abortion bans, via telehealth and mail-order services, a fact the Republican senators’ mention in their letter: “Unrestricted access to abortion pills is systematically undermining states’ rights and violating pro-life state laws. Every month, thousands of abortion drugs are shipped into states that have otherwise limited access to abortion after Dobbs, degrading pro-life laws at the state level across the country.”

The FDA’s approval of the drug for abortion through 10 weeks’ gestation remains in force, despite lawsuits filed in attempts to reverse it, and the safety of the drug is well-established, with rare complications. 

“The approval of generic mifepristone is an excellent – though increasingly rare example of the FDA working as it should: in a nonpartisan, thoughtful, evidence-based manner that prioritizes the health of the American people,” Kristin Lyerly, chair of the Committee to Protect Health Care’s board of directors and an obstetrician-gynecologist practicing in Wisconsin and Minnesota, said in a statement to the American Independent. 

“While not surprising, it remains disappointing that nearly every GOP Senator opposed this common-sense, data-driven process, putting politics before people. Their opposition reflects a compulsion to interfere with their constituents’ access to medication that has repeatedly been shown to be safe, effective, and lifesaving,” Lyerly said. 

The Republican senators’ letter recommends that the FDA suspend the approval of any new generic versions of mifepristone pending the outcome of a safety review. 

Mifepristone is regulated under the federal Risk Evaluation and Mitigation Strategy drug safety program, which is used to determine the classification of a drug. Only a health care provider who is certified under the Mifepristone REMS Program can prescribe the drug, and it can only be dispensed by or under the supervision of a certified prescriber or by an accredited pharmacy.

O’Connor noted: “One factoid that I learned just the other day is that mifepristone is also, even still, more heavily regulated than 99% of other drugs on the market, including opioids. So, yes, some regulations have been lifted over the years, but only after the rigorous FDA process, and again, there are still higher regulations on mifepristone than most other drugs.”