Washington, D.C. — More than 20 years ago, the U.S. Food and Drug Administration (FDA) approved mifepristone as safe and effective for the American people. Last April, a Texas district court ruling sought to block access to this medication in states across the country — a decision that had no basis in law or fact. Following petitions from the U.S. Department of Justice (DOJ) and branded manufacturer Danco Laboratories, and the submission of an amicus brief by generic manufacturer GenBioPro, the U.S. Supreme Court in Alliance for Hippocratic Medicine (AHM) v. FDA recognized the sweeping and devastating consequences of the lower court’s order and temporarily froze its ruling.
On August 16, the Fifth Circuit Court of Appeals issued a decision that would reinstate burdensome pre-2016 restrictions on mifepristone, but not remove the drug from the market. On September 8 and September 12 respectively, DOJ and Danco Laboratories filed petitions for writ of certiorari asking the Supreme Court to review the August 16 ruling by the Fifth Circuit.
Today, the Supreme Court agreed to grant both cert petitions.
In response to the Supreme Court’s order, Democracy Forward President & CEO Skye Perryman issued the following statement:
“We are pleased that the Supreme Court will review the Fifth Circuit’s ruling, which stands to harm people across the country and undermine the authority of the U.S. Food and Drug Administration (“FDA”). Importantly, today’s decision by the Supreme Court to review the Fifth Circuit’s ruling does not disturb the approval of generic mifepristone, and the medication remains lawful and available based on a prior stay the Supreme Court issued. We remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the FDA’s regulatory authority. This effort not only threatens the health of Americans across the country, it also undermines our democratic values. We will continue to use legal and regulatory tools to protect access to mifepristone and will oppose attempts to improperly use the courts to attack science and evidence.”
Democracy Forward is a national legal organization that is dedicated to the advancement of democracy and social progress. Democracy Forward, along with co-counsel, represents GenBioPro, the manufacturer of generic mifepristone on the amicus brief submitted in AHM v. FDA and in a lawsuit to reverse West Virginia’s restrictions that limit access to mifepristone.