US Senate Republicans launch probe of abortion pill makers, escalate pressure on FDA

By Ahmed Aboulenein

WASHINGTON, March 25 (Reuters) – U.S. Senate Republicans launched an investigation into abortion pill manufacturers on Wednesday and called on the U.S. Food and Drug Administration to crack down on online sales of the drug mifepristone, the latest escalation in a years‑long political battle over access to medication abortion.

The probe is led by Republican Bill Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee. It follows months of criticism by conservatives that the FDA has moved too slowly in reviewing the safety protocols surrounding mifepristone, particularly after former President Joe Biden’s administration eased in‑person dispensing requirements and expanded telehealth access. 

Here are some details:

* Senators seek detailed compliance records from all threeFDA‑approved manufacturers: Danco Laboratories, GenBioPro andEvita Solutions, including production sites, prescribercertifications, pharmacy audits, adverse event reports, salesdata and reasons for any prescriber or pharmacydecertifications.  * Lawmakers say online telehealth sellers pose safety,fraud  and coercion risks, citing websites that advertiseabortion pills past the FDA‑approved 10‑week limit or shipunregulated drugs from abroad in unmarked packaging.  * Republicans demand FDA enforcement tools, includingwarning letters to online sellers, abuse complaints to domainregistrars, interdiction of shipments with U.S. Customs andBorder Protection and the U.S. Postal Service, and criminalprosecutions modeled on past cases involving illegal pilldistribution.  * The push reflects broader conservative efforts toreinstate tougher Risk Evaluation and Mitigation Strategiesrestrictions, undo telehealth prescribing policies, and suspendapproval of new generic mifepristone products pending federalsafety reviews.  * The FDA is reviewing mifepristone’s safety protocols andaims to complete the process but some Republicans say the reviewis moving too slowly. * “The FDA is committed to protecting the public from theillegal marketing of drugs and is currently conducting itssafety study of mifepristone’s prescribing standards,” aDepartment of Health and Human Services spokesperson said. * Danco Laboratories declined to comment. GenBioPro said itlooked forward to educating lawmakers about medicationabortion. Evita Solutions did not immediately respond torequests for comment.

(Reporting by Ahmed Aboulenein in Washington; Editing by Matthew Lewis and Lincoln Feast.)