Home » GAO: FDA’s Monitoring of Early Abortion Drug Does Not Raise Safety Concerns
GAO: FDA’s Monitoring of Early Abortion Drug Does Not Raise Safety Concerns
Drugs Regulatory Affairs
The Government Accountability Office reviewed the FDA’s relabeling of Mifeprex — an early abortion pill covered by a risk evaluation and mitigation strategy — and concluded that the agency’s monitoring did not raise significant safety concerns.
Multiple members of Congress requested the GAO review prompted by concerns from stakeholders about the safety implications for women when relabeling removed a requirement that they have a second visit with a health care provider and increased the gestational age limit from 49 to 70 days.
The relabeling, approved in March 2016, also made changes to the indication and dosing regimen for Mifeprex (mifepristone), which included removing the requirement that the prescriber be a physician.