Senators Smith, Booker Introduce Legislation to Affirm Federal Regulation of Reproductive Health Products

WASHINGTON, D.C. [8.2.22] – Today, U.S. Senators Tina Smith (D-MN) and Cory Booker (D-NJ) introduced legislation that affirms the Food and Drug Administration’s (FDA) long standing preemptive authority over state law for all FDA-approved reproductive health products, including drugs used in medication abortion.

The U.S. Constitution’s Supremacy Clause prohibits states from interfering with the federal government’s power to regulate drugs. The Protecting National Access to Reproductive Care Act codifies this preemptive power and the Department of Justice’s authority to enforce federal laws and regulations. It also provides private individuals, and health care providers an avenue to sue states with laws banning or restricting access to these reproductive health products.

“After successfully overturning Roe and gutting 50 years of precedent protecting a woman’s freedom to make her own decisions about abortion, extremist Republicans aren’t stopping there,” said Sen. Smith. “We are already seeing the heart-breaking impact of this decision, yet Republican legislatures across the country continue to roll back critical protections and take aim at medication abortion. We must do everything in our power to protect women’s access to this essential care. No FDA approved medication has ever been banned by a state, and this bill will ensure that medication abortion drugs and other reproductive health products approved by the FDA remain accessible regardless of Republican efforts at the state level.”

“Since the Supreme Court defied nearly 50 years of legal precedent by overturning Roe v. Wade, jeopardizing the health care and reproductive freedom of millions of Americans, Republicans in state legislatures have continued their assault on reproductive rights by restricting access to medication abortion,” said Sen. Booker. “These restrictions threaten the right of Americans to make their own medical decisions and undermine the FDA’s clear legal authority. With this legislation, we are affirming that the FDA is the supreme entity that regulates and approves reproductive health products, and no state law can supersede this authority. This bill will give the federal government and aggrieved individuals the tools to challenge these unconstitutional laws and will help Americans living in areas with few or no abortion providers have access to abortion care.”

Medication abortion involves the use of prescription drugs, mifepristone and misoprostol, that are regulated under the Federal Food, Drug, and Cosmetic Act. Many states have restricted access to medication abortion after the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, despite the fact that the FDA, based on science not political ideology, has approved mifepristone and misoprostol to terminate pregnancies of up to 10 weeks. Medication abortion is also used to manage miscarriages to ensure the health and safety of the mother.

Specifically, the Protecting National Access to Reproductive Care Act would:

  • Affirm the FDA’s preemptive authority over reproductive health products.
  • Allow the Department of Justice to seek injunctive relief against States and state officials who prohibit or restrict access to reproductive health products (including medication abortion) in violation of the FDA’s preemptive authority.
  • Create a private cause of action for individuals and providers to seek injunctive relief against state and local officials in violation of federal law.
  • Provide funds for the Department of Justice to enforce the statute.

Full text of the legislation can be found here.