Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot
Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot
U.S. Senators Bill Cassidy, M.D. (R-LA), James Lankford (R-OK), Roger Marshall, M.D. (R-KS), Tommy Tuberville (R-AL), and Markwayne Mullin (R-OK) have requested an audit of safety standards at fertility clinics from the Department of Health and Human Services (HHS). The senators aim to ensure that human embryos are protected in these facilities.
The request comes as Congress considers legislation related to in-vitro fertilization (IVF). The senators seek a thorough examination of incidents such as the tragedy at the Center for Reproductive Medicine in Alabama, where destroyed embryos left parents devastated. They also want information on how the federal government collects and publishes data on fertility clinics, ensuring mothers using IVF have access to pregnancy success rates and other quality metrics when selecting a clinic.
“Mothers in this situation make a substantial emotional, financial, and personal investment, and rightly expect that fertility clinics will protect and respect human life—and keep treasured embryos safe,” wrote the senators.
“Women expect transparency with access to accurate pregnancy success rates and the certification status of the fertility clinics they are considering,” continued the senators. “It is unclear, however, whether CDC is implementing the law in such a manner as to maximally benefit the mothers it purportedly seeks to empower.”
Under federal law, clinics performing IVF must report annually on success rates and their certification status. While the Centers for Disease Control and Prevention (CDC) publishes an annual report on this data, recent reports lack information on whether certified clinics maintain adequate safety standards for embryos or if they received warning letters from the Food and Drug Administration (FDA) for significant deviations from federal requirements.
Concerningly, 39 out of 453 ART clinics reporting to CDC had no accreditation, and 33 clinics did not comply with reporting requirements in 2021.
The letter addressed to Ms. Grimm states: "We write to request that the Department of Health and Human Services Office of Inspector General (HHS OIG) audit the safety standards at fertility clinics and the quality of data collected by the Centers for Disease Control and Prevention (CDC) with respect to Assisted Reproductive Technology (ART) procedures to treat infertility."
The letter highlights several cases involving errors at fertility clinics across various states. These include incidents at Pacific Fertility Center in San Francisco, University Hospitals Fertility Center in Cleveland, California Center for Reproductive Health in Los Angeles, Kindbody's multiple locations nationwide, and Ovation Fertility in Newport Beach.
The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 governs ART programs and requires them to report data annually. However, implementation gaps exist regarding state inspections and federal validation inspections of embryo laboratories certified by states or accredited programs.
CDC’s most recent annual report notes that many facilities involved in reported cases were certified embryo laboratories accredited by CAP through RLAP—presumably in good standing. Despite this accreditation, patients may remain uninformed about safety standards due to lack of detailed public reporting.
The letter concludes by urging HHS OIG to evaluate ART clinic oversight comprehensively: "As Congress considers legislation related to IVF... we respectfully request that HHS OIG provide an evaluation and assessment of how well ART clinic oversight is working."
For updates from HELP Republicans, visit their website or Twitter @GOPHELP.
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