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 three FDA‑approved manufacturers: Danco Laboratories, GenBioPro and Evita Solutions, including production sites, prescriber certifications, pharmacy audits, adverse event reports, sales data and reasons for any prescriber or pharmacy decertifications.

• Lawmakers say online telehealth sellers pose safety, fraud and coercion risks, citing websites that advertise abortion pills past the FDA‑approved 10‑week limit or ship unregulated drugs from abroad in unmarked packaging.

• Republicans demand FDA enforcement tools, including warning letters to online sellers, abuse complaints to domain registrars, interdiction of shipments with U.S. Customs and Border Protection and the U.S. Postal Service, and criminal prosecutions modeled on past cases involving illegal pill distribution.

• The push reflects broader conservative efforts to reinstate tougher Risk Evaluation and Mitigation Strategies restrictions, undo telehealth prescribing policies, and suspend approval of new generic mifepristone products pending federal safety reviews.

• The FDA is reviewing mifepristone's safety protocols and aims to complete the process but some Republicans say the review is moving too slowly.

• "The FDA is committed to protecting the public from the illegal marketing of drugs and is currently conducting its safety study of mifepristone's prescribing standards," a Department of Health and Human Services spokesperson said.

• Danco Laboratories declined to comment. GenBioPro said it looked forward to educating lawmakers about medication abortion. Evita Solutions did not immediately respond to requests for comment.