Jaya White and Katie Lavigne Outline Mifepristone Considerations for Pharmacies in Article for Healthcare Business Today
Earlier this month, the U.S. Food and Drug Administration (FDA) revised its Mifepristone risk evaluation and mitigation strategy (REMS) program, creating a pathway for pharmacies to dispense the drug that can end a pregnancy through 10 weeks gestation.
Quarles & Brady attorneys Jaya White and Katie Lavigne wrote an article for Healthcare Business Today addressing what this means for pharmacies.
White is the Chicago office chair of the Health & Life Sciences Practice Group and Lavigne is a Minneapolis-based member of the group. In the article, they laid out the steps a pharmacy must take to receive Mifepristone certification and addressed the related implications of last year’s U.S. Supreme Court Dobbs decision.
An excerpt from the article:
While it’s only been a little over a year since the FDA added the pharmacy certification requirement to the Mifepristone REMS Program, the landscape has shifted considerably in the last several months with the U.S. Supreme Court’s June 24, 2022, ruling in Dobbs v. Jackson Women’s Health Organization. Without a constitutional right to abortion, pharmacy providers have been analyzing state laws and federal guidance to determine how best to meet patient needs. This FDA-approved certification process will ease some of that burden on pharmacy providers and provide an avenue for them to dispense Mifepristone within the parameters of the REMS Program. However, for pharmacies that deliver medications across state lines, choice of law issues remain. Mail order pharmacy providers that do business in several states still need to consider both the federal and state laws and guidance in how they approach the dispensing of Mifepristone.