New York, other states urge FDA to expand access to abortion pill

Reuters

05-06-2025

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and New Jersey asked the Food and Drug Administration to expand access to the abortion pill mifepristone, and remove outdated restrictions still in place 25 years after its approval.
Thursday's petition came after Health and Human Services Secretary Robert F. Kennedy Jr told Congress last month he directed FDA Commissioner Marty Makary to review the pill, saying "alarming" new data suggested at minimum that the label should be changed.
Mifepristone, together with the drug misoprostol, won FDA approval in 2000 for medication abortion in the first 10 weeks of pregnancy.
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.
New York Attorney General Letitia James said the FDA's Risk Evaluation and Mitigation Strategy program imposes "medically unnecessary" rules that keep mifepristone out of reach of most primary care settings.
She called the 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."
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.
The White House under Republican President Donald Trump has largely sided with abortion opponents, though 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.