November 18, 2022

Senator Warren, Lawmakers Encourage FDA to Consider Steps to Protect and Expand Access to Medication Abortion

“The Supreme Court’s reckless decision to overturn Roe v. Wade now endangers millions of women in this country who are facing restrictions to lifesaving care and rights”

Text of Letter (PDF)

Washington, D.C.— United States Senator Elizabeth Warren (D-Mass.) and eight Senate Democrats sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf encouraging the agency to defend Americans’ reproductive rights, and to consider steps to protect and expand access to medication abortion. 

“As states implement new restrictions, it is more important than ever that you take immediate steps to expand access to medication abortion,” wrote the lawmakers. “We encourage and support your efforts to protect access to abortion and reproductive rights across the nation.”

In the letter, the lawmakers encourage FDA to finalize the updated Risk Evaluation and Mitigation Strategy (REMS) for Mifepristone, consider lifting remaining medically unnecessary REMS restrictions, and work with drug sponsors to add a miscarriage management indication for Mifepristone taken with misoprostol.

For over two decades, women have been safely and effectively using medication abortion – Mifepristone and Misoprostol – to terminate a pregnancy. The two medications, when taken together, significantly improve the management of early pregnancy loss and result in fewer complications. Yet, right-wing state legislatures across the country have passed laws banning the use of medication abortion, further stripping away women’s access to abortion care and undermining the FDA’s authority to protect the nation’s public health.

This letter follows up on a previous August 4, 2022 letter led and sent by Senator Warren to the Department of Health and Human Services (HHS), urging the Department to take action and help meet President Biden’s goal of protecting and expanding access to medication abortion.

Following the Supreme Court’s decision to overturn 50 years of precedent and repeal Roe v. Wade in July 2022, President Biden released an Executive Order to protect access to reproductive health care services.  On August 26, 2022, HHS responded by publishing a report that included a recommendation to expand access to medication abortion through FDA finalization of updated REMS for Mifepristone “that have been found to be safe and effective.” 

The new letter is also signed by Senators Bernie Sanders (I-Vt.), Mazie Hirono (D-Hawaii), Kirsten Gillibrand (D-N.Y.), Angus King (I-Maine), Chris Van Hollen (D-Md.), Ed Markey (D-Mass.), Ron Wyden (D-Ore.), and Brian Schatz (D-Hawaii).

As access to abortion care services is under attack, Senator Warren has continuously called on the government to use every tool to expand and protect reproductive care:

  • On November 1, 2022, Senator Warren, Duckworth (D-Ill.), Hirono, and Smith (D-Minn.) released a report – based on information provided by leading health care providers – revealing the devastating consequences of state abortion bans and restrictions enacted by right-wing legislatures and the impacts of Senate Republicans’ extreme proposal to ban abortion nationwide after 15 weeks.
  • On August 4, 2022, Senator Warren, Mazie Hirono, and Tammy Baldwin (D-Wisc.) sent a letter to the Department of Health and Human Services (HHS) urging concrete actions the Department can take to help meet President Biden’s goal of protecting and expanding access to medication abortion.
  • On July 29, 2022, Senators Warren and Hirono led 23 of their colleagues in a letter to the Department of Veterans Affairs (VA), calling on the VA to take immediate administrative action to offer abortions and all abortion-related services to veterans and eligible dependents
  • On July 21, 2022, Senators Warren and Markey sent letters to Bark Technologies,, GoGuardian, and Securly Inc., raising concerns that the software these companies use to monitor students’ online activity could be used to criminalize or punish students who are seeking information about abortion services and reproductive health care.
  • On July 19, 2022, Senators Warren, Smith, and Murray (D-Wash.), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led a group of their Democratic colleagues in introducing the Expanding Access to Family Planning Act.
  • On July 14, 2022, Senators Warren, Booker (D-N.J), Padilla (D-Calif.) and over a dozen Senate Democrats wrote to President Biden and Health and Human Services (HHS) Secretary Xavier Becerra, urging them to immediately declare national and public health emergencies over Americans’ access to reproductive care.
  • On July 11, 2022, Senators Warren and Klobuchar (D-Minn.) sent letters to Facebook and Instagram, calling on them to address their reported censorship of posts related to abortion services, following the Supreme Court’s overturning of Roe v. Wade last month.
  • On July 7, 2022, Senator Warren announced two key data brokers’ commitments to permanently stop selling the location data of people seeking abortion services.
  • On June 23, 2022, Senators Warren and Bob Menendez (D-N.J.) and Representatives Carolyn Maloney (D-N.Y.) and Suzanne Bonamici (D-Ore.) introduced the Stop Anti-Abortion Disinformation Act, legislation that would crack down on false advertising that crisis pregnancy centers employ to dissuade patients from getting the reproductive care they need, including abortion care. 
  • On June 22, 2022, following the Supreme Court’s decision overturning Roe v. Wade, Senators Warren and Smith wrote an op-ed in the New York Times laying out the next steps in the fight to protect the right to an abortion, including calling for the declaration of a public health emergency.
  • On June 15, 2022, Senator Warren introduced the Health and Location Data Protection Act, legislation that bans data brokers from selling some of the most sensitive data available about everyday Americans: their health and location data. 
  • On June 7, 2022, Senators Warren and Patty Murray led 23 of their Senate colleagues in a letter to President Biden urging him to immediately issue an executive order directing the federal government to develop a national plan to defend Americans’ fundamental reproductive rights, including their right to an abortion.
  • On May 17, 2022, Senator Warren led thirteen of her Senate colleagues in letters to two data brokers demanding answers regarding their collection and sale of the cellphone-based location data of people who visit abortion clinics such as Planned Parenthood. 
  • On May 10, 2022, Senator Warren delivered a speech on the floor of the United States Senate on the need to protect the constitutional right to an abortion, pass the Women’s Health Protection Act, and fight back against Republican extremism. 
  • On May 9, 2022, Senator Warren wrote an op-ed in Marie Claire about the need to enshrine the right to an abortion in federal law. 
  • On May 3, 2022, when the draft Supreme Court opinion that would overturn Roe v. Wade was leaked, Senator Warren spoke on the steps of the Supreme Court twice to activists, protestors, and the nation about the need to protect abortion rights.