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Support and Value Expectant (SAVE) Moms and Babies Act of 2019 (H.R. 4399)

This law was last updated on Sep 28, 2019


This law is Anti–Choice

State

Federal

Number

H.R. 4399

Status

Proposed

Proposed

Sep 19, 2019

Sponsors

Co-sponsors: 37
Primary Sponsors: 1
Total Sponsors: 38

Topics

Medication Abortion, Physicians Reporting Requirements, Reporting Requirements

Full Bill Text

www.congress.gov

H.R. 4399 would amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval of new abortion drugs, prohibit investigational use exemptions for abortion drugs, and impose additional regulatory requirements with respect to previously approved abortion drugs.

The bill would prohibit the Secretary from approving any application for marketing an abortion drug or from granting an investigational use exemption for an abortion drug or any investigation in which the human embryo or human fetus of a person known to be pregnant is knowingly destroyed.

For any previously approved abortion drugs, the Secretary would be prohibited from approving any labeling change to approve the drug after 70 days gestation or to approve the dispensing of the drug by any means other than in-person administration by the prescribing health-care practitioner.

Any previously approved abortion drug would be subject to a risk evaluation and mitigation strategy that at a minimum:

  • requires health-care practitioners who prescribe such abortion drug:
    • to be certified in accordance with the strategy; and
    • to not be acting in their capacity as a pharmacist;
  • as part of the certification process, requires such practitioners:
    • to have the ability to assess the duration of pregnancy accurately;
    • to have the ability to diagnose ectopic pregnancies;
    • to have the ability to provide surgical intervention in cases of incomplete abortion or severe bleeding;
    • to have the ability to ensure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary; and
    • report any deaths or adverse events to the FDA and the manufacturer or the abortion drug;
  • limits the dispensing of medication abortion to patients:
    • in a clinic, medical office, or hospital, in-person, by the prescribing health-care practitioner; and
    • not in pharmacies.
  • requires the prescribing health-care practitioner to provide the patient with documentation on any risks or complications associated with the abortion drug;
  • requires all known adverse events associated with the drug to be reported to the FDA by the manufacturers and prescribes of the drug; and
  • requires medication abortion reporting in the same manner as surgical abortion.

Reporting Requirements

The bill would require all other health-care practitioners to report to the FDA any adverse events experienced by their patients that are connected to the use of an abortion drug.


Latest Action

9/19/19 – Introduced; referred to the House Committee on Energy and Commerce.


People