The prior comments from Kennedy are raising fears that the HHS chief is open to restrictions on the pill.
“President Trump has asked me to study the safety of mifepristone,” Kennedy said during a confirmation hearing. “He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.”
Health policy experts do not think that Kennedy will try to remove the drug from the market straight away. Instead, they think he might direct agencies within HHS to change who can take mifepristone and how it can be administered.
Right now, mifepristone can be prescribed online and sent through the mail and is approved to end a pregnancy in the first 10 weeks of gestation.
Health experts who spoke to The Hill agreed the easiest way Kennedy could change access to the drug is through trying to alter its Risk Evaluation and Mitigation Strategies (REMS). REMS are regulations added to some medications with safety concerns.
REMS changes typically take time, but there’s concern that the Trump administration could try to speed up the process by issuing an executive order based on a study claiming mifepristone is dangerous for public consumption and applying pressure to the FDA to restore previous restrictions.
What’s a REMS: The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medications are safe and effective.
One of the ways the agency does this is by implementing REMS.
REMS can include some interventions to ensure the safe use of a drug, like requiring patients to undergo certain tests before they can be prescribed a medication or requiring that it be administered in clinic.
Mifepristone has had a REMS since it was first approved by the FDA in 2000, and it’s been modified multiple times over the years, most recently in 2023 when the FDA dropped an in-person dispensing requirement for the drug.
Changing the REMS for a drug is not normally a quick process. Often, it is the drug manufacturer that requests changes to these rules, although the FDA can also request changes. Typically, the agency needs to work with the manufacturer to roll out those modifications.
