The Food and Drug Administration has launched a safety study of the abortion pill mifepristone, a step administration officials said could lead to restrictions on how the drug is distributed and used. The study, using the agency’s existing drug-safety surveillance systems, is expected to take about six months and aims to withstand legal scrutiny, according to administration officials.
The study marks a victory for antiabortion groups and Republican members of Congress, who have demanded action from the Trump administration to crack down on the pill’s use. In recent months, antiabortion allies had lost patience with assurances from administration officials that a study would be conducted, amid allegations — denied by both the White House and the FDA — that the administration was dragging its feet to avoid political controversy before the midterm elections.
Some administration officials said the agency had been making preparations by acquiring data and examining whether a study was feasible. They said the administration had kicked the study into high gear because of conversations with antiabortion groups and a coming October deadline set by a Louisiana judge this spring as part of ongoing litigation over the abortion pill. The administration is aiming for a robust study that will withstand legal criticism, the administration officials said.
The FDA website currently states that mifepristone, approved decades ago, is safe to use as indicated. It is unlikely the FDA would aim to remove the drug from the market entirely, as removing any drug from the market is highly difficult. Antiabortion advocates have instead set their sights on the agency changing rules that allow the drug to be distributed through the mail and via telehealth.
“We already know chemical abortions kill babies and endanger women,” Sen. Bill Cassidy (R., La.), chairman of the Senate’s health committee, said in a statement. “The Trump administration needs to stop dragging their feet and immediately reinstate the in-person requirement.”
Antiabortion advocates have alleged that telehealth distribution of mifepristone has led to misuses of the medication and harmful health outcomes for women, including hemorrhaging. During the pandemic, the pills were first allowed to be prescribed virtually and shipped by mail. After the Supreme Court’s decision overturning Roe v. Wade, virtual prescribing ballooned, with doctors in blue states shipping the pills to red states where abortion faces more restrictions.
Abortion-rights groups have said the pills are safe and that concerns about telehealth distribution are a veiled attempt to roll back access. About 65% of abortions in the U.S. use the mifepristone pill regimen, according to the Guttmacher Institute. Studies have repeatedly shown that mifepristone is safe, including when prescribed remotely and taken at home. Antiabortion groups say those studies are flawed and that the federal government does not closely track serious, nonfatal side effects.
“Hopefully they will adhere to FDA’s gold standard for science and we will learn once again that mifepristone is a safe and effective medicine, and the telehealth model of care is also safe and effective,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project.
Former FDA Commissioner Marty Makary, ousted last month, had promised lawmakers he would launch a mifepristone study but told others in the administration that he needed new data systems for the effort, administration officials said. The current study is using existing drug-safety surveillance systems at the agency, according to the administration officials.
The study launch was initiated by FDA leaders but has the White House’s blessing, people familiar with the matter said. In addition to the FDA study, the agency is also considering hiring a contractor to acquire and analyze data on mifepristone use, the administration officials said.
Some administration officials said they hope to have results from the study by the end of the year. They said they also expect to have preliminary, internal results in July and plan to give an update to the Louisiana court by the October deadline. They said a separate court ruling legally obligated them to examine both the drug’s current telehealth rules and earlier, stricter protocols.
In the days following Makary’s departure, acting FDA Commissioner Kyle Diamantas called leaders in the antiabortion movement to reassure them he was committed to their cause despite previous legal work for Planned Parenthood, according to a person familiar with the conversations. According to a public calendar entry, he also met in May with Cassidy, who has pushed the FDA to do the safety study.
It is unclear if the FDA’s study will be enough to appease antiabortion groups critical of the administration. “This study needs to be thorough,” said Kristi Hamrick, spokeswoman for Students for Life of America. “We have a lot of unanswered questions before we can be excited.”