Representative Lee Leads Congressional Democrats in Filing Amicus Brief in ACOG v. FDA

Press Release

Today, Representatives Barbara Lee (CA-13), Diana DeGette (CO-01), Jan Schakowsky. (IL-9), Ayanna Pressley (MA-07), and Jerrold Nadler (NY-10), as well as Senators Richard Blumenthal (D-CT), Dianne Feinstein (D-CA), Mazie Hirono (D-HI), and Ron Wyden (D-OR), led 148 Members of Congress in filing an amicus brief in the case of American College of Obstetricians and Gynecologists v. United States Food and Drug Administration (ACOG v. FDA). The brief challenges the FDA's in-person dispensing requirement for the abortion medication mifepristone during the COVID-19 public health emergency.

The amicus brief focuses on the importance of ensuring that science and medical evidence guide access to medication abortion and miscarriage care. It argues that the court should affirm the preliminary injunction granted by the District Court, which lifted the in-person Risk Evaluation and Mitigation Strategy ("REMS") requirements for mifepristone for early abortion use during the global pandemic, and that the court should also reverse the District Court's decision to decline to extend the preliminary injunction to patients seeking mifepristone for the treatment of early pregnancy loss.

"Lifting the in-person requirements for mifepristone is consistent with various FDA and HHS actions that encourage and promote the use of telemedicine in lieu of in-person visits during the COVID-19 pandemic," the lawmakers wrote in their brief. "Given that FDA does not require any medical counseling and eligibility assessments to be provided to the patient during in-person dispensing, there is no rational reason why patients who seek mifepristone to treat early miscarriages should not be afforded the same protections as those who need the drug for medication abortions.

"Upholding mifepristone's in-person REMS requirements during the COVID- 19 pandemic is at odds with public health guidance, statutory intent, and common sense--it is medically unnecessary, burdens patient access to mifepristone, and imposes irreparable harm to miscarriage and medication abortion patients and their medical providers. [The lawmakers] respectfully ask the Court to affirm the District Court's decision granting a nationwide preliminary injunction on Plaintiffs-Appellees' due process claim, and to reverse the District Court's ruling on Plaintiffs-Appellees' equal protection claim to reinstate urgently-needed relief for miscarriage and medication abortion patients and their medical providers during the pandemic."

Due to the COVID-19 pandemic, the federal government?has suspended?similar in-person requirements for other, less safe medications. Yet, the Trump Administration ignored repeated calls by leading medical and public health authorities to do the same for mifepristone, continuing to treat patients seeking abortion and miscarriage care differently. In a letter?to former U.S. Food and Drug Administration Commissioner, Stephen Hahn, sent on June 16, 2020, members urged the FDA to ease the dispensing restrictions on mifepristone in light of the ongoing COVID-19 pandemic.