Senator Wants Review of FDA Data behind Decision to End In-Person Dispensing Requirement for Abortion-Inducing Meds

042822 Ag Approps FY23 FDA
VIDEO CLIP:  Senator Hyde-Smith Will Seek Review of Material Behind FDA Chemical Abortion Decision.
VIDEO:  Senator Hyde-Smith Questions FDA Commissioner on Access to Mail-Order Abortion Pills.

WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.) today said she wants a full review of the data that led to the recent Food and Drug Administration decision to end in-person dispensing requirements for chemical abortion pills, a move that puts the health of women at risk.

Hyde-Smith challenged the “mail-order abortion” decision while questioning FDA Commissioner Robert Califf, M.D., who testified Thursday at a Senate Agriculture Appropriations Subcommittee hearing to review the agency’s FY2023 budget request.  In February, Hyde-Smith led a letter to Califf seeking to overturn the December decision to remove in-person dispensing requirements from the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone.

“Your response, which I did get last week, said that you had conducted ‘a comprehensive review’ of the REMS Program, and that you concluded that even without the in-person dispensing requirement, the drug would be ‘safe and effective.’  I and many others disagree with that.  There is plenty of evidence showing these chemical abortion pills are dangerous to the women who take them, and can be extremely dangerous in certain situations,” Hyde-Smith said

“It is the job of the FDA and your job as commissioner to protect patients by ensuring the safety of drugs.  The stronger REMS that had been in place since 2019 included safeguards to protect patients from unnecessary risk posed by the drug,” she added.

Hyde-Smith, citing Cardiff’s “unequivocal belief that your review was fully comprehensive,” indicated she will request information on all literature used by the FDA to broaden access to the abortion-inducing drug.

Hyde-Smith, who highlighted Charlotte Lozier Institute research on the dangers of mail-order abortions in a March op-ed, expressed her concern that chemical abortions now make up a majority of all abortions in the United States, including an 11 percent jump in Mississippi in 2019.

“This is, of course, a serious concern of mine from talking to my OB/GYN friends.  As you said you want to see the number of abortions go down, what are you doing to reverse this trend of increasing chemical abortions and actually help lower the numbers?” Hyde-Smith asked Califf.

Related to this issue, Hyde-Smith and U.S. Congressman Bob Latta (R-Ohio) in January 2021 introduced the Support and Value Expectant (SAVE) Moms and Babies Act (S.78 and HR.554) to prevent labeling changes for already-approved abortion drugs; prevent providers from dispensing these drugs remotely, by mail, or via tele-medicine; and prevent FDA approval of new chemical abortion drugs.