Four jurisdictions request the Food and Drug Administration to eliminate regulations on the use of the abortion pill.

Four jurisdictions request the Food and Drug Administration to eliminate regulations on the use of the abortion pill.

Here's a no-holds-barred take on the latest abortion pill controversy that's shaking up the States:

On Thursday, the attorneys general of California, Massachusetts, New Jersey, and New York petitioned the Food and Drug Administration (FDA) to loosen regulations on abortion pills. They argue that the FDA's current guidelines make it a pain in the ass for primary care providers to prescribe mifepristone - one of the pills involved in medication abortions - in routine medical settings.

"Mifepristone's 25-year track record speaks for itself - there's no scientific reason to keep tossing these unnecessary roadblocks in front of patients and providers," shouts New York Attorney General Letitia James in her fiery statement.

The drug is a hot-button issue in the abortion debate. Anti-abortion groups, see it as a golden opportunity to restrict abortion access nationwide by limiting who can get their hands on mifepristone or rescinding its approval entirely.

The petition comes hot on the heels of FDA Commissioner Marty Makary's promise to conduct a thorough safety review of mifepristone. Health and Human Services Secretary Robert F. Kennedy Jr. and Sen. Josh Hawley (R-Mo.) were among those who called for the review after a questionable report was released claiming a high rate of serious adverse events in women taking the medication.

But researchers in the reproductive health field have dismissed the report as junk science, accusing it of blowing the risks of mifepristone out of proportion. They point out that the report fails to meet basic research standards, relying on overly broad definitions and keeping mum about the data source.

The report was dropped by the Ethics and Public Policy Center, a conservative think tank known for its role in the advisory board of Project 2025 - a right-wing policy initiative that targeted FDA approval of mifepristone for axing.

The attorneys general urged the FDA to take the safety review as an opportunity to knock down barriers to accessing mifepristone across the U.S., or at the very least, in the four states that signed the petition.

Deconstructing the Debate: A Closer Look at Safety and Access

The FDA's Safety Program and Mifepristone: A Deep Dive

The FDA regulates potentially risky medications through the Risk Evaluation and Mitigation Strategies (REMS) program. Mifepristone is part of this program, despite a mountain of evidence showing that less than 0.5% of women who take it experience serious adverse reactions[1][4].

Studies have also found that dispensing mifepristone via telehealth is just as safe and effective as administering it in person[2].

Under the REMS program, certain conditions apply:

• Practitioners prescribing the pills must be certified health care providers.
• Pharmacies must obtain certifications to distribute the medication.
• Patients receiving mifepristone must sign a form noting their intention to terminate their pregnancy.

The attorneys general argue these restrictions are hard on the balls and unnecessary, as many primary care and family medicine physicians lack the willingness or ability to take on the administrative burden of obtaining certification to prescribe the pills, or fear being labeled local or national abortion providers.

The struggle for broader access

Over the past decade, the FDA has eased a number of restrictions on mifepristone. In 2016, it extended the window in which mifepristone could be used to terminate pregnancies from seven weeks to ten weeks. In 2019, it green-lighted a generic form of the medication, boosting supply. And in 2021, it scrapped the requirement for in-person dispensing, allowing for telehealth prescriptions and mail delivery.

Anti-abortion groups want the FDA to reverse those decisions, pointing to misleading studies that suggest the medication is dangerous[3]. The April report that triggered the FDA safety review, for example, claims to find a 22-times higher rate of serious complications from mifepristone compared to the FDA's recorded figures.

In their petition, the four attorneys general slam recent attempts to discredit mifepristone's safety, which they say rely on biased and methodologically flawed research.

A suit filed by a coalition of anti-abortion groups against the FDA in 2022 over its approval of mifepristone cited two studies from the Charlotte Lozier Institute, a group that opposes abortion, which claimed to reveal severe complications from the drug. The lawsuit was tossed by the Supreme Court, and the studies were later withdrawn by a medical publisher.

The Charlotte Lozier Institute released another paper last month suggesting that a growing number of emergency room visits following abortions are falsely attributed to miscarriages, concealing abortion complications.

Rachel Jones, a principal research scientist at the Guttmacher Institute, a research organization that supports abortion access, said the data only covers a fraction of abortions and slants the findings toward higher-risk procedures. The same data was used in the retracted studies, she added.

Jones also revealed that the release of these reports by anti-abortion groups isn't a coincidence.

"The anti-abortion crusaders are really gunning for medication abortion and doing whatever they can to force the FDA under the Trump administration to reconsider the availability of the drug," she declared.

1. The debate surrounding mifepristone, a drug used in medication abortions, has seen scientists and medical professionals push back against claims of high adverse event rates, branding reports suggesting otherwise as "junk science."
2. In the realm of health and wellness, women's health, and general news, the political landscape is being shaped by ongoing discussions about policy and legislation related to mifepristone, with four states urging the FDA to ease restrictions on the drug.
3. Amidst the controversies, researchers in the reproductive health field assert that the use of telehealth for dispensing mifepristone is as safe and effective as in-person administration, countering anti-abortion groups who seek to reverse FDA decisions relaxing restrictions on the drug.
4. The stance of anti-abortion groups on mifepristone, a key player in the abortion debate, illustrates their efforts to outline policies that could limit the availability of the drug nationwide, relying on studies that have been criticized for methodological flaws and bias.

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