The House Committee on Oversight and Reform is calling on the FDA to lift the in-person requirement for medication abortion care—”in light of the clear danger the requirement poses to people seeking reproductive health care at the height of the coronavirus pandemic.”
On Tuesday, Jan. 12, six members of the Supreme Court granted a Trump administration request to reinstate an FDA rule requiring patients seeking medication abortion to make an unnecessary in-person visit to their health care provider just to pick up the medication and sign a form.
Justices Sotomayor, Kagan and Breyer dissented from the Court’s decision and would have denied Trump’s request.
“The FDA’s policy imposes an unnecessary, unjustifiable, irrational and undue burden on women seeking an abortion during the current pandemic,” said Justice Sotomayor. (Read Justice Sotomayor’s scathing dissent in full.)
Justices Sotomayor, Kagan and Breyer join many in opposition of the majority decision—which places patients at needless risk and directly contradicts medical science, say experts.
“It is disgraceful and frankly frightening that instead of listening to expert medical and scientific consensus about the safety of medication abortion and the risks imposed by these unwarranted restrictions, the Supreme Court chose to listen to politicians with an anti-science, anti-abortion agenda,” said Dr. Jason Matuszak, president of New York State Academy of Family Physicians. “It’s past time for the FDA to eliminate these baseless restrictions—not only during the pandemic, but for good.”
But just weeks after the inauguration of the Biden-Harris administration, the House Committee on Oversight and Reform submitted a letter calling on the FDA to lift the in-person requirement for medication abortion care.
Read the House Oversight Committee’s full letter to FDA Acting Commissioner Dr. Janet Woodcock below.
Feburary 9, 2021
Dear Dr. Woodcock:
We are writing to request that the Food and Drug Administration (FDA) lift the medically unnecessary in-person dispensing requirement for mifepristone, a prescription medication that has been used to safely end early pregnancies for more than two decades in our country. Imposing this requirement in the midst of a deadly pandemic—one that has disproportionately impacted communities of color across the United States—needlessly places patients and providers in harm’s way, and further entrenches longstanding health inequities.
The FDA created the Risk Evaluation and Mitigation Strategies (REMS) program to ensure the safe use of medications that pose “serious safety concerns” for patients. For mifepristone—the first of two drugs used to complete a medication abortion—FDA requires that the pill be dispensed to patients in person by certified health care providers, and only in certain health care settings. Of the more than 20,000 drugs regulated by FDA, mifepristone is the only drug that FDA requires patients to obtain in person at a hospital, clinic, or medical office, but does not restrict the ability of patients to self-administer—unsupervised—at home or at a location of their choosing.
Since its approval by the FDA in 2000, more than four million people in the United States have used mifepristone. According to data made available by FDA, less than 0.1% of patients who took mifepristone experienced major adverse events. By comparison, hundreds of people in the United States who carry their pregnancies to term die annually in childbirth. According to the American College of Obstetricians and Gynecologists (ACOG), FDA’s REMS restrictions for mifepristone “have no medical basis, provide no patient benefit, and unnecessarily restrict access to care.”
Early in the pandemic, FDA suspended certain in-person REMS requirements, acknowledging the health risk of these requirements and the difficulty they posed for patients who are self-isolating or quarantining. Despite lifting other REMS restrictions, including in- person prescribing requirements for regulated medications, FDA declined to suspend the in- person dispensing requirement for mifepristone.
On May 27, 2020, ACOG led a group of plaintiffs in asking a federal court to order FDA to suspend the in-person dispensing requirement for mifepristone during the coronavirus pandemic. On July 13, 2020, the U.S. District Court for the District of Maryland ordered FDA to suspend the in-person dispensing requirement, concluding that “such infringement on the right to an abortion would constitute irreparable harm” and noting that in-person requirements had been waived for many other drugs in the interest of protecting public health.
Following this ruling, the Trump Administration asked the Supreme Court to intervene and issue a stay on the District Court’s injunction of the in-person dispensing requirement while it appealed the ruling. The Supreme Court initially declined to intervene in the case, but a majority of justices agreed to reconsider the Administration’s request after Justice Amy Coney Barrett joined the bench.
On January 12, 2021, the Supreme Court granted the Trump Administration’s request for a stay on the District Court’s injunction, reinstating the in-person dispensing requirement for mifepristone. In a dissenting opinion, Justice Sonia Sotomayor, joined by Justice Elena Kagan, noted that “maintaining the FDA’s in-person requirements for mifepristone during the pandemic not only treats abortion exceptionally, it imposes an unnecessary, irrational, and unjustifiable undue burden on women seeking to exercise their right to choose.”
In light of the clear danger that the reinstated requirement poses to people seeking comprehensive reproductive health care at the height of the coronavirus pandemic, we urge you to immediately eliminate the medically unnecessary in-person dispensing requirement for mifepristone.
The Committee on Oversight and Reform is the principal oversight committee of the House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X. If you have any questions regarding this request, please contact Committee staff at (202) 225-5051.
Sincerely,
Carolyn B. Maloney, Chairwoman, Committee on Oversight and Reform
Ayanna Pressley, Member
Eleanor Holmes Norton, Member
Alexandria Ocasio-Cortez, Member
Katie Porter, Member
Rashida Tlaib, Member
Cori Bush, Member
Debbie Wasserman Shultz, Member
Jackie Speier, Member
Robin Kelly, Member
Brenda L. Lawrence, Member
cc: The Honorable James R. Comer, Ranking Member
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