Four Democratic-led US states urge FDA to remove abortion pill restrictions

Reuters

2 days ago

NEW YORK, June 5 (Reuters) - The attorneys general of New York, California, Massachusetts and New Jersey asked the Food and Drug Administration to expand access to the abortion pill mifepristone, and remove what they view as outdated and medically unnecessary restrictions.
Thursday's petition by the Democratic-led states seeks to force the FDA to acknowledge what the states view as "extensive" evidence that mifepristone is safe, notwithstanding the Trump administration's general opposition to abortion.
It came after Health and Human Services Secretary Robert F. Kennedy Jr told Congress last month he ordered FDA Commissioner Marty Makary to review the pill, and unspecified "alarming" new data suggested the government should at least change the label.
Mifepristone is the first pill, followed by the drug misoprostol, for medication abortion in the first 10 weeks of pregnancy, and won FDA approval in 2000.
Medication abortions account for more than half of U.S. abortions, though 28 states restrict access, according to the nonprofit Guttmacher Institute, which focuses on reproductive health.
The petition challenges FDA requirements that mifepristone prescribers be included in national and local abortion provider lists, patients attest in writing that they intend to end their pregnancies, and pharmacies perform a variety of recordkeeping.
Citing the drug's safety record, it said those rules, part of the FDA's Risk Evaluation and Mitigation Strategy program, are "no longer justified by science or law," especially in states where abortion is legal and comprehensively regulated.
New York Attorney General Letitia James said the rules keep mifepristone out of reach of most primary care settings. She called that problem particularly acute in rural and other areas where getting abortions often requires lengthy travel.
"There is simply no scientific or medical reason to subject it to such extraordinary restrictions," James said, referring to mifepristone. "The FDA must follow the science."
A spokeswoman for the Department of Health and Human Services said FDA Commissioner Makary "will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes."
Many states, primarily Republican-led or leaning, have restricted or substantially eliminated abortions in the three years since the U.S. Supreme Court overturned Roe v. Wade, the 1973 decision that legalized the procedure nationwide.
Last June, the Supreme Court preserved broad access to mifepristone, unanimously ruling that a group of anti-abortion organizations and doctors lacked legal standing to challenge the FDA's approval of the pill.
Despite largely siding with abortion opponents, Republican President Donald Trump said during his 2024 campaign he did not plan to limit access to mifepristone.
Last month, the administration asked a federal judge to dismiss, on procedural grounds, a lawsuit by three generally Republican states seeking to narrow such access.
That lawsuit began during the administration of Democratic President Joe Biden, who generally supported abortion access.
Seventeen other Democratic-led or -leaning states plus Washington, D.C., are separately suing the FDA in Spokane, Washington, to loosen restrictions on mifepristone.
They said doctors and pharmacies should be able to dispense the pill, as with most drugs, without special certifications.
On May 30, the Trump administration urged a dismissal, saying the states didn't show the FDA's policy was flawed or the agency ignored important evidence.
The states filed Thursday's petition after a short delay, with the filing having been expected earlier in the morning.