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Hirono, Lawmakers Urge FDA to Consider Steps to Protect and Expand Access to Medication Abortion

WASHINGTON, D.C. – U.S. Senator Mazie K. Hirono (D-HI) joined eight Senate Democrats in a letter, led by Senator Elizabeth Warren (D-MA), 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 medication abortion drug 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.

Following the Supreme Court’s decision to overturn nearly 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.” 

In addition to Senators Hirono and Warren, the letter was also signed by Senators Bernie Sanders (I-VT), Kirsten Gillibrand (D-NY), Angus King (I-ME), Chris Van Hollen (D-MD), Ed Markey (D-MA), Ron Wyden (D-OR), and Brian Schatz (D-HI).

The full text of the letter is available here.

A long-time champion for abortion access, Senator Hirono is committed to protecting the fundamental right to abortion care for all. In August, she led a letter to the Department of Health and Human Services urging them to make medication abortion more easily accessible. Earlier this month, Senator Hirono released a report revealing the devastating consequences of state abortion bans and restrictions on women’s access to health care. In August, she also introduced the Let Doctors Provide Reproductive Health Care Act to protect doctors against Republicans’ non-stop attacks and ensure they can safely provide abortion care in states where it is still legal. In July, Senator Hirono introduced the Right to Contraception Act, as well as the Expanding Access to Family Planning Actto protect access to critical reproductive health care services, like birth control, and cancer screenings. She also introduced the Freedom to Travel for Health Care Act of 2022, which clarifies that it is illegal for anti-choice states to limit travel for abortion services, and would empower impacted individuals to bring civil action against those who restrict a woman’s right to cross state lines to receive legal reproductive care.