S. 1631: Restoring Safeguards for Dangerous Abortion Drugs Act

This bill, titled the Restoring Safeguards for Dangerous Abortion Drugs Act, primarily focuses on the medication mifepristone, which is used for medical abortions, and outlines several actions related to its regulation and use.

Key Provisions of the Bill

1. Risk Evaluation and Mitigation Strategy (REMS)

The bill mandates the Secretary of Health and Human Services to:

• Withdraw the current risk evaluation and mitigation strategy for mifepristone within 90 days of the bill's enactment.
• Re-approve a risk evaluation and mitigation strategy that is identical to the one that was last approved in June 2011.

This means that the government would need to reassess how mifepristone is distributed and its potential risks based on an older framework, rather than any current guidelines.

2. Restrictions on Approval of New Strategies

Under the bill, the Secretary of Health and Human Services is prohibited from approving any new risk strategies or alterations to the previously mentioned strategy, ensuring the use of the old guidelines remains in effect.

3. Liability for Harm Caused by Mifepristone

The bill introduces provisions regarding liability for entities involved with the distribution of mifepristone:

• A covered entity (such as a telehealth provider or pharmacy) would be liable for any bodily injury or mental health harm caused to individuals who use the medication if the covered entity imported or transported the drug illegally.
• Individuals harmed could file civil lawsuits for damages against these entities, including claims for compensatory and punitive damages, and for attorney's fees.

4. Effective Date

The liability provisions would take effect 90 days after the bill becomes law, suggesting a specific timeline for implementation once enacted.

5. Ban on Importation

The bill also proposes an amendment to existing laws to explicitly prohibit the importation of mifepristone into the United States, stating that individuals cannot mail the drug to others. This prohibition aligns with the overall focus of the bill on restricting access to mifepristone.

Relevant Companies

• MYMD (MyMD Pharmaceuticals): As a company involved in pharmaceuticals, particularly in areas related to drug development, changes in regulations surrounding mifepristone could impact their operations or market dynamics.
• VRNA (Verona Pharma): This biotech firm focuses on developing new therapeutics and could be indirectly affected by shifts in the market or public interest in abortion-related medications.
• AMGN (Amgen): As a major player in biotechnology, regulatory changes can influence the development pipelines related to similar therapeutic areas.