H.R. 5646: Restoring Safeguards for Dangerous Abortion Drugs Act

This bill, titled the Restoring Safeguards for Dangerous Abortion Drugs Act, is designed to establish stricter regulations regarding the abortion drug mifepristone, also known by brand names like Mifeprex and Korlym. Below are the key provisions outlined in the bill:

Definitions

The bill defines "covered medication" explicitly as mifepristone.

Risk Evaluation and Mitigation Strategy (REMS)

The Secretary of Health and Human Services (HHS) is mandated to take the following actions concerning mifepristone:

• Withdraw the current risk evaluation and mitigation strategy for mifepristone that is in effect at the time the bill is enacted.
• Approve a new risk evaluation and mitigation strategy identical to the one that was approved in June 2011.

Furthermore, the Secretary is restricted from approving any risk evaluation and mitigation strategy that differs from the 2011 version.

Liability for Harm

The bill introduces a federal liability framework for specific entities that may cause harm through the importation or transportation of mifepristone. The details include:

• A "covered entity" is defined as any telehealth provider, pharmacy, or person that knowingly imports or transports mifepristone improperly.
• These entities would be liable to individuals who suffer various forms of harm (physical, psychological, emotional, or physiological) due to their use of mifepristone.
• Individuals who experience such harm would have the right to pursue a civil lawsuit against these entities for:
  • Compensatory damages
  • Punitive damages
  • Attorney’s fees and costs

The bill clarifies that it does not preempt any state laws that provide additional remedies for affected individuals.

Ban on Importation

The legislation also amends federal law to include provisions that prohibit the importation of mifepristone into the United States. This includes:

• Explicitly stating that no individual may import mifepristone, including through mailing.

Effective Date

The provisions related to liability and the ban on importation would take effect 90 days after the enactment of the bill.

Relevant Companies

• MRVI - Marinus Pharmaceuticals: May be impacted due to potential changes in the regulatory landscape affecting mifepristone.
• AXAS - Axovant Gene Therapies Ltd.: Could experience regulatory implications if involved in similar medication areas.