H.R. 7902: Safeguarding Women from Chemical Abortion Act

This bill, titled the Safeguarding Women from Chemical Abortion Act, aims to take specific actions regarding the drug mifepristone, which is used for terminating pregnancies. The major components of the bill are as follows:

Withdrawal of Approval for Mifepristone

The bill proposes that:

• The approval for mifepristone, known as Mifeprex or RU-486, for the purpose of terminating intrauterine pregnancies is deemed to have been withdrawn 14 days after the bill is enacted.
• Once the approval is withdrawn, introducing or delivering this drug into interstate commerce will be considered a violation of the Federal Food, Drug, and Cosmetic Act.
• The drug will be labeled as misbranded if it suggests it can be used for the termination of pregnancy or in combination with another drug for this purpose.

Establishment of Federal Tort for Harm

The bill also establishes a federal tort related to mifepristone:

• A "covered entity," defined as a person or company that manufactures mifepristone, would be liable if an individual suffers bodily injury or mental health harm attributable to the use of this drug.
• Individuals harmed could sue these covered entities for compensatory damages, punitive damages, and for attorney’s fees and costs incurred during the legal process.
• The bill emphasizes that it does not override state laws that may offer different remedies for such injuries.

Effective Dates

The provisions related to the withdrawal of the drug's approval are set to become effective 14 days after the bill is enacted, while the parts concerning liability and the ability to file lawsuits would take effect 90 days after enactment.

Other Provisions

No parts of the Act would alter any existing provisions of a specific federal law regarding other matters related to obscenity.

Relevant Companies

• MYL (Mylan N.V.): May be impacted due to their involvement in the manufacture or distribution of mifepristone or similar medications.
• TEVA (Teva Pharmaceutical Industries Ltd): As a manufacturer of pharmaceutical products, they could face legal liability or loss of market for mifepristone if the bill is enacted.
• SYRX (Sorrento Therapeutics, Inc.): If engaged in producing similar medications, they may also be directly affected by the provisions of the bill.