A girl as young as 13 years old can buy abortion pills, according to an undercover investigation that made test purchases of the drug.
Sen. Bill Cassidy, chairman of the Senate Committee on Health, Education, Labor and Pensions, published a report Thursday based on a five-month investigation into Food and Drug Administration-approved sponsors of the chemical abortion drug mifepristone.
The probe sought to uncover information about the companies’ business practices and the implementation of federally mandated requirements governing the marketing, distribution and prescription of mail-ordered mifepristone.
Cited is a video published by Dr. Christina Francis of the American Association of Pro-Life OBGYNs. She ordered mifepristone through the online seller Aid Access while posing as a 13-year-old with an IUD, anemia, blood-thinning medication, three prior C-sections and an ectopic pregnancy a year earlier.
She said she was approved within two minutes of submitting the online form, and GenBioPro’s generic mifepristone arrived by mail within a week. There were no follow-up questions and no direct contact with a prescriber, she added.
“Abortion drug companies are putting mothers at risk through their failure to properly oversee the prescription and distribution of their products. We are seeing that the explosion in online sales of chemical abortion drugs has opened the door to coercion and abuse of women,” Mr. Cassidy, Louisiana Republican, said in a statement. “FDA and the sponsors of these drugs have a responsibility to the American people to crack down on these prescribers that violate the prescribing requirements and reinstate the safeguards that keep mothers and babies safe.”
The FDA’s Risk Evaluation and Mitigation Strategies program requires special certification for doctors and pharmacies, signed patient agreement forms and secure shipping rules to safely distribute mifepristone for medical termination of pregnancy up to 10 weeks gestation.
REMS requires mifepristone sponsors to decertify healthcare providers and pharmacies that “do not maintain compliance with certification requirements.”
Neither Danco Laboratories nor GenBioPro, two FDA-approved mifepristone sponsors, has decertified a prescriber in the history of REMS. Danco has decertified two pharmacies, and GenBioPro has decertified nothing, according to the report.
Both companies also told the committee they do not audit or independently verify individual prescribers, asserting that the onus is on prescribers to self-police.
Danco and GenBioPro also redacted data in their FDA REMS assessments that they disclosed elsewhere to Mr. Cassidy.
Danco redacted the number of certified prescribers, certified pharmacies and authorized distributors despite providing those numbers in other responses. The company also redacted its audits of authorized distributors and certified pharmacies while still providing summary information, according to the report.
GenBioPro redacted its number of certified pharmacies while supplying those numbers in its responses.
Danco also reported roughly 4,000 nonfatal adverse events from 2000 to 2016 but only 150 in the decade since prescribers stopped being required to report them to sponsors, the report says.
Despite selling over 850,000 units of mifepristone between 2019 and 2023 and holding a majority of the market, GenBioPro has reported about 10 nonfatal adverse events in seven years.
Over six years, in which an estimated 3.8 million women took mifepristone, zero ectopic pregnancies were reported to the FDA, according to the report.
“The findings in this investigation demonstrate a consistent pattern of a lack of transparency regarding the operations of mifepristone sponsors and raise critical questions about the effectiveness of their oversight of the supply chain for their drugs and prescribers to ensure compliance with REMS requirements,” the report reads.
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