Senate HELP Chair Cassidy Accuses Mifepristone Makers of Ignoring FDA Safety Compliance
核心洞察
Sen. Bill Cassidy's Senate HELP Committee report accuses mifepristone manufacturers of failing to ensure compliance with FDA safety regulations, particularly for online third-party sales.
The report calls on the Department of Justice and FDA to act, including reestablishing an in-person dispensing requirement for mifepristone.
Cassidy cites Aid Access as advertising mifepristone through 14 weeks of pregnancy, beyond the FDA's 10-week limit, and highlights a sharp drop in reported non-fatal adverse events.
Sen. Bill Cassidy, chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, is accusing abortion pill manufacturers of failing to meet their legal responsibilities to ensure compliance with Food and Drug Administration (搜索) (FDA) safety regulations, particularly when the pills are sold online through third-party providers.
A report issued Thursday by Cassidy follows the committee's monthslong investigation into the three mifepristone manufacturers: Danco Laboratories (搜索), GenBioPro (搜索) and Evita Solutions (搜索). The report calls on legal and regulatory authorities to take action.
Cassidy, who is leaving Congress in January, accuses abortion pill makers of allowing third-party retailers to sell the drugs without oversight and of failing to report non-fatal adverse events. He says the Department of Justice should explore legal avenues to address willful noncompliance with safety requirements, and that the FDA should take immediate action to reestablish an in-person dispensing requirement for mifepristone.
"We are seeing that the explosion in online sales of chemical abortion drugs has opened the door to coercion and abuse of women," Cassidy said in a statement. Cassidy has not yet announced any coming legislative action or hearings on the topic.
Online Sales and REMS Compliance Concerns
The report uses the example of the website Aid Access, which allows individuals to order mifepristone online without an in-person patient-provider relationship. This sort of telehealth prescribing is allowed under the Biden-era rules. The website was launched by a physician and abortion-rights activist.
Cassidy's report states it is unclear who is providing the drug when ordered online and whether those parties are certified in the FDA's Risk Evaluation and Mitigation Strategy (REMS) program. The Aid Access website also advertises prescribing mifepristone through 14 weeks of pregnancy — beyond the 10-week limit set by the FDA.
Cassidy says that Danco and GenBioPro (搜索) told his committee throughout its investigation that the companies have no role in ensuring that health care providers who prescribe mifepristone maintain compliance with FDA requirements. Both Danco and GenBioPro have links on their websites to Aid Access.
Adverse Event Reporting Gap
The committee report also notes that since the Obama administration removed a requirement that providers report non-fatal adverse events to mifepristone makers, very few incidents have been reported. Drugmakers and congressional Democrats have pointed to that scarcity of non-fatal adverse events as evidence of the drug's safety. For example, from 2000 to the 2016 change, Danco had reported roughly 4,000 non-fatal adverse events related to mifepristone, but the company has only reported 150 non-fatal adverse events in the last 10 years, the report says.
Pending Court Action
Meanwhile, a pending court case in which Louisiana is suing the FDA could determine the availability of mail and telehealth abortion pills nationwide. The Fifth Circuit Court of Appeals is scheduled to hear oral arguments on Sept. 9. The Supreme Court intervened in the case earlier this year, granting an emergency request from abortion drug makers to preserve telemedicine access to medication abortion while the case continues.
The abortion drug has been available in the U.S. for 25 years, but became more widely accessible in 2021 when the Biden administration lifted the in-person dispensing requirement. By 2023, it accounted for 63 percent of all abortions in the U.S., according to the Guttmacher Institute, a research and policy organization focused on sexual and reproductive rights and health.
Contrasting Views on Safety and Access
Democrats argue that medication abortion has undergone rigorous FDA scrutiny and has been used safely for 25 years by over 7 million women. They also say that allowing medication abortion via telehealth and mail delivery reduces unnecessary burdens on care, especially for patients in rural areas or living in states with strict abortion bans.
"Preserving evidence-based access to mifepristone, including when dispensed by mail or retail pharmacy, is necessary to mitigate the imminent harm facing members of the public," more than 250 House and Senate Democrats wrote in an amicus brief to the Supreme Court regarding mifepristone access.
Meanwhile, the FDA is working on an internal review of the drug's safety amid political pressure from anti-abortion groups, after having defended its approval for years before President Donald Trump was elected. Cassidy has accused the FDA of "dragging its feet" on the review of the safety of the abortion drug. The agency did not respond to requests for comment on the status of this review.