Well being and Human Companies (HHS) Secretary Robert F. Kennedy Jr. has recommended that he’s open to limiting entry to abortion treatment, the first methodology used for abortions throughout the U.S.
Kennedy pledged to review the abortion drug mifepristone on President Trump’s request throughout his affirmation hearings, citing “safety issues.” He didn’t supply additional clarification of what these points had been.
“President Trump has asked me to study the safety of mifepristone,” Kennedy mentioned through the hearings final 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 search to limit entry to the drug, well being coverage specialists don’t suppose Kennedy will try to take away it from the market, however say he may as a substitute attempt to direct companies inside HHS to restrict who can take mifepristone and the way it may 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,” mentioned Caleb Alexander, a doctor and professor on the Johns Hopkins Bloomberg College of Public Well being with analysis give attention to drug utilization and security.
HHS oversees 13 companies together with the Meals and Drug Administration (FDA), which is chargeable for defending public well being partially by ensuring that the nation’s drug provides are protected and efficient for consumption.
A method the FDA tries to make sure that medicines are protected is by implementing Danger Analysis and Mitigation Methods (REMS). These are a collection of guidelines the company imposes on some medication to stop, monitor and handle the frequency or severity of antagonistic well being occasions, in line with the FDA’s web site. They will embody some interventions to make sure the protected use of treatment, like an in-person meting out requirement. Mifepristone was beforehand below such a requirement till the Biden administration dropped it.
Altering the REMS related to the drug could be essentially the most direct approach to change who can take it and the way, well being specialists mentioned.
Although modifications to REMS are sometimes requested by the drug producer, the FDA may decide if a change is required, in line with company tips. It nonetheless sometimes must work with the drug producer in these circumstances, nonetheless.
“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 company’s web site reads.
To alter REMS for a drug, the FDA would want to supply proof that itposes a hazard to folks and that the present REMS don’t shield customers nicely sufficient from these dangers, well being specialists mentioned.
The FDA first authorised the abortion treatment Mifeprex in 2000 and greater than 100 research carried out in not less than 26 international locations have discovered that almost all sufferers who’ve taken the drug haven’t skilled a severe complication like hospitalization or surgical procedure.
Usually, the method for altering REMS doesn’t occur “overnight,” in line with Laurie Sobel, affiliate director of ladies’s well being coverage at well being analysis nonprofit KFF.
However she suggestedthe course of could possibly be completely different below Trump, saying the administration may potentiallyissue an emergency declaration primarily based on a research arguing that mifepristone is harmful and revert again to earlier REMS for the drug.
Such a transfer may ultimately make it more durable to entry to drug by reinstituting guidelines thatallowed solely sure clinicians the best to prescribe it, she mentioned.
Since 2000, the abortion treatment has had a collection of REMS which have been modified. The Biden-era FDA’s announcement in 2021 that it woulddrop its requirement that the drug be allotted in particular person to sufferers marked one of many more moderen modifications.
That requirement was formally dropped in 2023, with the company releasing new REMS for the drug.
Along with in search of to roll again that change, the Trump FDA may additionally probably recommend putting new necessities within the REMS that sufferers in search of mifepristone should endure particular assessments earlier than they are often given the drug or be noticed for a sure period of time in clinic after it, in line with Alexander.
If the company had been to recommend modifications to REMS for mifepristone, the drug’s producers Danko Laboratories and GenBioPro, which creates a generic model of the drug, would possible problem the modifications in court docket, well being specialists mentioned.
“But it’s unclear how successful that challenge might be,” mentioned Sobel.
The FDA didn’t reply questions from The Hill about REMS for mifepristone.
