FDA rule change 'turns neighborhood pharmacies into abortion providers,' pro-lifers say
The first drug in the chemical abortion pill regimen can now legally be dispensed via prescription at major retail pharmacy chains after a regulatory change by the U.S. Food and Drug Administration, a move that pro-life groups warn threatens women's safety.
The FDA modified restrictions on the abortion pill Tuesday after reviewing the Mifepristone REMS Program, which the agency started in 2021.
Mifepristone, the generic version of Mifeprex, falls under the risk evaluation and mitigation strategy (REMS), which sets standards for abortions up until 10 weeks gestation.
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In response to a Wednesday inquiry from The Christian Post, the FDA pointed to its web pages on mifepristone and some frequently asked questions regarding the drug. The information page about mifepristone was updated Tuesday.
Under the new regulation, retail pharmacies that complete a certification process may dispense the abortion pill. Women can also obtain a prescription through a telehealth appointment and receive the pills by mail.
On its frequently asked questions page, which the FDA updated Wednesday, the agency denied that the new regulations had anything to do with the overturn of Roe v. Wade and several states outlawing or restricting abortion.
The agency has been reviewing published literature and data from advocacy groups and "applicants related to the modifications" since 2021.
Danco Laboratories, an abortion pill manufacturer, released a statement proclaiming it is "pleased" with the change. The manufacturer claimed that chemical abortion access is "critically important" nowadays and that the updated regulations will "provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy."
In a Wednesday statement provided to CP, Chelsey Youman, national legislative advisor for the pro-life group Human Coalition Action, condemned the move, calling it "indefensible."
"This is an unconscionable act by an agency tasked with upholding public health and safety, and is pure sop to the abortion industry," Youman stated. "It eliminates safety requirements that these pills be given by a physician and turns neighborhood pharmacies into abortion providers, putting many pharmacists in an impossible position of having to dispense abortion pills against their conscience beliefs."
Youman expressed concern that women taking the abortion pill at home without a doctor present could lead to serious side effects, such as hemorrhaging. According to the FDA, heavy bleeding is one side effect of taking mifepristone. Youman worries that the FDA under the Biden administration is prioritizing the expansion of abortion pill access over women's safety.
March for Life President Jeanne Mancini seconded this concern in a statement to CP.
"The Biden administration's doing away with even the most basic of medical oversight for the very serious chemical abortion regimen is simply heartbreaking, and women will suffer the most from this reckless decision," Mancini wrote. "Access to chemical abortion without proper medical oversight runs contrary to science and is not in the best interest of women's health."
Planned Parenthood, the nation's largest abortion provider, contends that the pill has a track record of being a "safe and effective way to end an early pregnancy." The group says it's most effective when pregnancies are nine weeks old or less.
"Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care," Planned Parenthood President Alexis McGill Johnson said in a statement.
Sue Liebel, director of state affairs and midwest regional director of Susan B. Anthony Pro-Life America, cited a 2009 study that found chemical abortions have four times the complication rate of surgical abortions.
"The immediate message that we are sending is that this is very reckless, and this is the FDA, yet again, peeling back health and safety regulations surrounding these dangerous drugs," Liebel told CP.
In December 2021, the FDA permanently lifted the requirement for women to obtain mifepristone in person from a health provider after temporarily suspending the requirement during the COVID-19 pandemic.
As of Tuesday, the FDA officially removed the in-person requirement for mifepristone but still mandates that dispensers show they're certified to treat abortion pill complications and that women complete a consent form.
The FDA claims on its updated webpage that "available data and information" support the REMS modification "to reduce [the] burden on the health care delivery system and to ensure the benefits of the product outweigh the risks."
However, Liebel said the data collection on abortion in the U.S. is "abysmal," noting that the country does not have a federal mandate requiring states to report abortion complications.
The pro-life advocate cited a 2021 peer-reviewed longitudinal study conducted by the Charlotte Lozier Institute, the research arm for SBA Pro-Life America.
Researchers claim that the rate of emergency room visits after a chemical abortion increased by over 500% from 2002 through 2015. The researchers also noted that by 2015, 60.9% of emergency room visits due to chemical abortion pill complications were miscoded as miscarriages.
The study suggests that Mifepristone abortions grew from 4.4% of total abortions in 2002 to 34.1% in 2015
Liebel believes that state legislatures should require better reporting of emergency room complications and still require an in-person exam before dispensing the abortion pill. As the pro-life advocate noted, the FDA did not prohibit states from requiring an in-person examination at the local level.
She also emphasized the importance of screening women for health complications, such as an ectopic pregnancy or RH compatibility, which would require medical treatment.
"There's a lot of opportunity here for misuse, including a woman not correctly anticipating the gestational age of her baby," Liebel said, noting that women are not supposed to take the abortion pill beyond 10 weeks gestation.
As CP reported, multiple medical professionals, represented by the Alliance Defending Freedom, filed a lawsuit in November, challenging the FDA for approving chemical abortion pills and repeatedly loosening restrictions.
"The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an 'illness' and argue that these dangerous drugs provide a 'meaningful therapeutic benefit' over existing treatments," the lawsuit reads.
"But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion," the legal filing continues. "In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs."
Samantha Kamman is a reporter for The Christian Post. She can be reached at: samantha.kamman@christianpost.com. Follower her on Twitter: @Samantha_Kamman
