New Jersey Attorney General Matthew J. Platkin, alongside the attorneys general of California, Massachusetts, and New York, has filed a petition with the U.S. Food and Drug Administration (FDA) seeking the removal of restrictions on mifepristone, a medication used for abortion.
The coalition argues that mifepristone is safe and effective, as demonstrated over the 25 years since its FDA approval. They claim that the current Risk Evaluation and Mitigation Strategy (REMS) program unnecessarily restricts access to this medication without enhancing patient safety.
The petition coincides with an FDA review of mifepristone labeling requirements initiated by Secretary of Health and Human Services Robert F. Kennedy, Jr. Attorney General Platkin urges the FDA to use this review to lift what he calls "unjustified restrictions" and improve access to the medication.
Attorney General Platkin stated, “We will never waver in our support for reproductive freedom... Access to mifepristone saves lives and is critical for reproductive choice.”
Mifepristone, often combined with misoprostol, is widely used in early pregnancy termination in the United States and managing early miscarriages. Despite its extensive use by over 7.5 million people since 2000 and a strong safety record acknowledged by leading medical organizations, it remains under a REMS program intended for drugs with significant risks.
The REMS program includes prescriber certification, patient agreement forms, and pharmacy certification—requirements that Platkin's coalition argues are unnecessary and hinder access to care, particularly in rural areas.
Currently, medication abortions are mostly confined to specialized settings due to these restrictions. The coalition highlights that nearly 90 percent of U.S. counties lack an abortion provider.
Platkin emphasizes that these constraints are not applied to other riskier medications like opioids or blood thinners. The attorneys general also note that the REMS burdens emergency rooms and pharmacies due to certification challenges.
Under federal law, REMS requirements must address specific serious risks without imposing undue burdens on patients or healthcare systems. The coalition contends that mifepristone’s REMS does not meet these criteria given its safety record.
The attorneys general seek complete elimination of the mifepristone REMS program or at least exemption from its enforcement in states where abortion is legal and healthcare systems are well-regulated.
