FDA moves ahead with safety study of abortion pill mifepristone

The Food and Drug Administration is moving ahead with a safety study of the abortion pill mifepristone, a senior FDA official confirmed to CBS News, a step that could create a path for the Trump administration to restrict access to the medication.

It will be a retrospective study of hundreds of thousands of cases, according to the official. The interim results of the study could be released in July, but the official noted the timing of the final results will depend on the design of a secondary analysis after the interim results come in.

The Wall Street Journal was first to report on the new developments with the study.

Administration officials dispute the study is just starting. A White House spokesperson said it has been underway for months and is moving from a new phase focused on analyzing data the agency has already collected.

In a statement, a spokesperson for the FDA said the agency has been "actively working on a science-based review" of the abortion pill for months.

"Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work," the spokesperson said. 

Last September, Health and Human Services Secretary Robert F. Kennedy Jr. wrote in a letter to several Republican state attorneys general that the FDA was reviewing the safety of mifepristone.

At the time, Kennedy and then-FDA Commissioner Martin Makary wrote, "HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug."

Yet Makary came under scrutiny from some Congressional Republicans and anti-abortion groups who believed the agency was dragging its feet on the study under his watch for political reasons.  

The drug came under renewed scrutiny after the Biden administration issued a memorandum lifting restrictions that required the drug to be dispensed in-person and giving access to mifepristone via telehealth and by mail.

Last year, the state of Louisiana filed a lawsuit challenging the FDA's decision to allow mifepristone to be delivered by mail.

On May 4, the U.S. Court of Appeals for the 5th Circuit temporarily reinstated the rule requiring mifepristone to only be dispensed in person.

However, the following week, the Supreme Court set aside the lower court order and allowing, for now, mifepristone to continue to be delivered to patients through the mail while the Louisiana case plays out in the courts.  

Mifepristone, which was first approved by the FDA in 2000 as a safe way to end early pregnancies, is typically taken with a second drug, misoprostol.

Asked last year whether a review of mifepristone could lead to a ban, CBS News medical correspondent Dr. Celine Gounder suggested it would be difficult for the FDA to withdraw approval, an extraordinary step that would quickly draw legal challenges. 

However, Gounder said that depending on what the safety review finds, it could make access more difficult, limiting the drug's availability through telehealth or by mail, or restricting the ability to prescribe it to doctors rather than physician assistants or nurses who are also currently able to prescribe it.

Editor's Note: This story has been updated to include a statement from the White House and the FDA.