The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.

The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.

In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.

In addition to these studies, FDA is conducting a review of the Mifepristone REMS Program. Among other things, that review encompasses consideration of arguments and information submitted to the Agency in multiple pending Citizen Petitions.

These Petitions advocate for a wide range of agency actions, including reinstating certain REMS requirements previously removed from the REMS, such as the requirement that the drug be dispensed only in certain healthcare settings (the “in-person dispensing requirement”). 

Following completion of its study and review, FDA will decide whether changes to the Mifepristone REMS Program are necessary and, if applicable, initiate any such changes in accordance with established processes.

... FDA responds to court-ordered deadline with claims it will complete its mifepristone safety review in March 2027. That’s 2+ years after HHS Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary first pledged to “study the safety” of abortion pills.

U.S. District Judge David Joseph initially granted the FDA a stay allowing its current mail-order abortion scheme to continue as long as the agency agreed to provide the court with a review status update “on or before six months from the date of this [Apr. 7th] order.”

Joseph warned that “should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change.”

[In April,] the judge ordered the matter "STAYED pending completion of FDA’s ongoing review" but would only afford FDA a "time limited period of deference to complete its review," writing that the "stay granted to FDA will not remain open-ended."
He ordered:

• 60 Days: FDA must produce entirety of the administrative record to Plaintiffs’ counsel.

• 6 Months: FDA must file a report providing the Court with the status of its review.

• 14 Days: After FDA completes its REMS review, FDA shall file a brief advising the Court of any agency action.

"Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change," the judge wrote.

The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.

The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022. Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.

In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person. But the Supreme Court quickly blocked the decision while the case plays out.

In addition to these studies, FDA is conducting a review of the Mifepristone REMS Program. Among other things, that review encompasses consideration of arguments and information submitted to the Agency in multiple pending Citizen Petitions.

These Petitions advocate for a wide range of agency actions, including reinstating certain REMS requirements previously removed from the REMS, such as the requirement that the drug be dispensed only in certain healthcare settings (the “in-person dispensing requirement”). 

Following completion of its study and review, FDA will decide whether changes to the Mifepristone REMS Program are necessary and, if applicable, initiate any such changes in accordance with established processes.

... FDA responds to court-ordered deadline with claims it will complete its mifepristone safety review in March 2027. That’s 2+ years after HHS Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary first pledged to “study the safety” of abortion pills.

U.S. District Judge David Joseph initially granted the FDA a stay allowing its current mail-order abortion scheme to continue as long as the agency agreed to provide the court with a review status update “on or before six months from the date of this [Apr. 7th] order.”

Joseph warned that “should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change.”

[In April,] the judge ordered the matter "STAYED pending completion of FDA’s ongoing review" but would only afford FDA a "time limited period of deference to complete its review," writing that the "stay granted to FDA will not remain open-ended."
He ordered:

• 60 Days: FDA must produce entirety of the administrative record to Plaintiffs’ counsel.

• 6 Months: FDA must file a report providing the Court with the status of its review.

• 14 Days: After FDA completes its REMS review, FDA shall file a brief advising the Court of any agency action.

"Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change," the judge wrote.