The drugs, if they’re going to be marketed, have to be safe, says Bill Cassidy, a Louisiana Republican and chair of the Health, Education, Labor and Pensions (HELP) Committee.
Right now, that’s not clear, Cassidy says, and particularly troublesome are the unregulated drugs shipped into the U.S. from overseas.
“They're unregulated. We don't know the chemical content. We don't know if they're safe. Of course, we know if they have their intended effect, that the child dies, but we also want to protect the mother. And right now, we're not sure that is happening,” Cassidy said on “Washington Watch” Tuesday.
Key objectives of the investigation include manufacturer compliance, enforcement by the Food and Drug Administration (FDA) and reinstating safeguards.
While Cassidy pressures the FDA, the wheels of justice aren’t turning fast enough for the senator.
Dr. Martin Makary was confirmed in March of 2025 as Donald Trump’s pick to lead the FDA.
The FDA's promised safety review of mifepristone is ongoing but has not been completed. A Trump-appointed judge in Louisiana, David C. Joseph, ruled on Tuesday to pause a lawsuit challenging the drug's mail-order availability, specifically ordering the FDA to complete its review and report back to the court in six months.
The deadline is notable as the agency had sought to push completion of its review past the November mid-term elections. Tuesday’s ruling requires that the review be completed a month before.
“At this juncture, it is the completion of FDA's promised good faith, evidence-based, and expeditious review [and] not 'government by lawsuit' that this Court finds to be in the public interest,” Joseph wrote.
The Louisiana Attorney General's office has said it will appeal the judge's decision and ask the 5th Circuit Court of Appeals to block the 2023 FDA rule allowing mifepristone to be dispensed through the mail.
The FDA has approved mifepristone for medical pregnancy termination at up to 70 days (10 weeks) gestation and in 2023 modified during the Biden administration the Risk Evaluation and Mitigation Strategy (REMS) program to allow dispensing through certified pharmacies and telemedicine, removing the prior in-person dispensing requirement.
Cassidy’s committee wants the FDA to reinstate the removed safety protocols, particularly the in-person dispensing requirement.
He contends this change alone has increased risks of patient harm, coercion and undetected adverse events.
“There are a whole lot of issues as regards to these abortion drugs. Let's just start with that,” he told show host Tony Perkins.
The minimal federal regulations for chemical abortion drugs are the jurisdiction of the FDA.
“This FDA has turned a blind eye to issues that are important to those who are pro-life, for example, approving generic abortion drugs without the requirement to have the REMS database. That's looking for complications. There's evidence that the way women are taking these pills now have an increased rate of complications that should be thoroughly investigated. It is not being thoroughly investigated,” Cassidy said.
In spite of his ruling, Joseph conceded the expanded access of mail-order abortion drugs and their impact on pro-life states like Louisiana.
"Thus, in the post-Dobbs regulatory environment, there is evidence that the 2023 REMS was approved without adequate consideration, at least in part, as part of an effort to circumvent anti-abortion states’ ability to regulate abortion," Joseph wrote. "Likewise, there is evidence that the consequences of this action were predictable — out-of-state providers and related entities would expand access to mifepristone in ways designed to reach into jurisdictions like Louisiana."
No action from Trump admin
Cassidy is puzzled that the Trump administration has not acted to block those out-of-state mail-order abortion providers.
“I don’t know why not, and that’s what we’re pursuing in our investigation,” he said.
Use of abortion drugs is not as simple as taking an over-the-counter painkiller, Cassidy says. The risk of complications is far greater, and that’s why federal guidelines are necessary.
There are instances when a young pregnant woman is coerced by someone else in her life to take the drugs.
“So, an in-person visit would allow a doctor to say, ‘wait, are you being coerced? If you're coerced, I'm not going to give you medicine and (will) call the police because you shouldn't be taking this unless you know the complication which is going to occur.’ That’s what we're trying to inform people about, and that's why the FDA should be taking a more aggressive action on it,” Cassidy said.
