How RFK Jr. could restrict abortion medication access

Yahoo

27-02-2025

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested that he is open to restricting access to abortion medication, the primary method used for abortions across the U.S.
Kennedy pledged to study the abortion drug mifepristone on President Trump's request during his confirmation hearings, citing 'safety issues.' He did not offer further explanation of what those issues were.
'President Trump has asked me to study the safety of mifepristone,' Kennedy said during the hearings last month. 'He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.'
If the administration does seek to restrict access to the drug, health policy experts do not think Kennedy will attempt to remove it from the market, but say he could instead try to direct agencies within HHS to limit who can take mifepristone and how it can be administered.
'If you are trying to make a product harder to access … you are going to institute restrictions that reduce the ease in which people can access the product,' said Caleb Alexander, a physician and professor at the Johns Hopkins Bloomberg School of Public Health with research focus on drug utilization and safety.
HHS oversees 13 agencies including the Food and Drug Administration (FDA), which is responsible for protecting public health in part by making sure that the country's drug supplies are safe and effective for consumption.
One way the FDA tries to ensure that medications are safe is by implementing Risk Evaluation and Mitigation Strategies (REMS). These are a series of rules the agency imposes on some drugs to prevent, monitor and manage the frequency or severity of adverse health events, according to the FDA's website. They can include some interventions to ensure the safe use of medication, like an in-person dispensing requirement. Mifepristone was previously under such a requirement until the Biden administration dropped it.
Altering the REMS associated with the drug would be the most direct way to change who can take it and how, health experts said.
Though changes to REMS are often requested by the drug manufacturer, the FDA can also determine if a change is needed, according to agency guidelines. It still typically needs to work with the drug producer in those cases, however.
'The FDA may release a REMS or remove certain components of a REMS, if, after review of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication's benefits outweigh its risks,' the agency's website reads.
To change REMS for a drug, the FDA would need to provide evidence that itposes a danger to people and that the current REMS do not protect consumers well enough from those risks, health experts said.
The FDA first approved the abortion medication Mifeprex in 2000 and more than 100 studies conducted in at least 26 countries have found that most patients who have taken the drug have not experienced a serious complication like hospitalization or surgery.
Typically, the process for changing REMS doesn't happen 'overnight,' according to Laurie Sobel, associate director of women's health policy at health research nonprofit KFF.
But she suggestedthe process could be different under Trump, saying the administration could potentiallyissue an emergency declaration based on a study arguing that mifepristone is dangerous and revert back to earlier REMS for the drug.
Such a move could eventually make it harder to access to drug by reinstituting rules thatallowed only certain clinicians the right to prescribe it, she said.
Since 2000, the abortion medication has had a series of REMS that have been modified. The Biden-era FDA's announcement in 2021 that it woulddrop its requirement that the drug be dispensed in person to patients marked one of the more recent modifications.
That requirement was officially dropped in 2023, with the agency releasing new REMS for the drug.
In addition to seeking to roll back that change, the Trump FDA could also possibly suggest placing new requirements in the REMS that patients seeking mifepristone must undergo specific tests before they can be given the drug or be observed for a certain amount of time in clinic after it, according to Alexander.
If the agency were to suggest changes to REMS for mifepristone, the drug's manufacturers Danko Laboratories and GenBioPro, which creates a generic version of the drug, would likely challenge the changes in court, health experts said.
'But it's unclear how successful that challenge might be,' said Sobel.
The FDA did not answer questions from The Hill about REMS for mifepristone.
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