E&C Democrats Request Committee Hearing on Unprecedented Decision Undermining FDA Approval for Mifepristone

All 23 Energy and Commerce Committee Democrats sent a letter to Chair Cathy McMorris Rodgers (R-WA) and Health Subcommittee Chair Brett Guthrie (R-KY) requesting an immediate hearing on the unprecedented decision by a federal court in the Northern District of Texas in Alliance for Hippocratic Medicine v. FDA staying the approval of mifepristone, a drug that has been approved by the Food and Drug Administration (FDA) for more than 22 years. The Department of Justice has appealed the District Court's decision, which is scheduled to go into effect on April 14

"As Members of the Committee of jurisdiction over FDA and our nation's drug approval process, we have an important responsibility to review and consider any detrimental impacts or threats to FDA's ‘Gold Standard' of review," the 23 Committee Democrats wrote. "Given the implications of this decision, we believe it is important for the Committee to hear from experts about how the outcome of this case attempts to undermine the drug approval process, restricts access to an FDA-approved medication, and places ideology, politics, and judicial activism above science."

In their letter, the Committee Democrats also cited their deep concerns about the impact of the ongoing effort to limit women's access to reproductive health care nationwide.

"We have grave concerns about the ongoing attacks to reproductive health care in the United States, and the implications for those who seek abortion care following the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization, which overturned nearly 50 years of precedent protecting the Constitutional right to abortion," the E&C Democrats continued. "Unfortunately, Alliance for Hippocratic Medicine is one more example of ideologically driven litigation that is intended to restrict abortion access and block women from obtaining the care they need, while also turning back the clock on reproductive rights and bodily autonomy."

E&C Democrats also pointed out that the decision could have long-term implications that undermine our nation's public health agencies and our prescription drug approval process.

"More than a dozen renowned food and drug law scholars have noted that the outcome in this case could ‘profoundly undermine the well-established statutory and regulatory framework for the approval of new drugs and the due process accorded to drug marketing application holders by statute,'" Committee Democrats concluded in their letter. "These experts also emphasized that requiring FDA to withdraw the approval of mifepristone would ‘create harmful reverberations that would affect patients, health care providers, and the biopharmaceutical industry, all of whom rely on the expertise of FDA to make scientific determinations regarding the safety and effectiveness of our nation's medical products.' Given the breadth of these stakeholders and implications, it is critical that we hear from those impacted on the effects of this decision."

The letter was signed by Reps. Frank Pallone, Jr. (D-NJ), Anna G. Eshoo (D-CA), Diana DeGette (D-CO), Jan Schakowsky (D-IL), Doris Matsui (D-CA), Kathy Castor (D-FL), John P. Sarbanes (D-MD), Paul Tonko (D-NY), Yvette Clarke (D-NY), Tony Cárdenas (D-CA), Raul Ruiz, M.D. (D-CA), Scott H. Peters (D-CA), Debbie Dingell (D-MI), Marc A. Veasey (D-TX), Annie Kuster (D-NH), Robin L. Kelly (D-IL), Nanette Diaz Barragan (D-CA), Lisa Blunt Rochester (D-DE), Darren Soto (D-FL), Angie Craig (D-MN), Kim Schrier, M.D. (D-WA), Lori Trahan (D-MA), and Lizzie Fletcher (D-TX).

The full letter is available HERE.