FDA will review abortion pill safety – will it be impartial?

Last year, it seemed that the battle to preserve access in the US to mifepristone as an option for abortion had been won, but as the Trump administration launches a review of the drug, it looks like the war isn't over.

A letter from HHS Secretary Robert F Kennedy Jr. and FDA Commissioner Martin Makary, in which they confirmed that the FDA is conducting a 'review' of mifepristone's safety, has raised the spectre of controls being placed on the drug without evidence of harm.

It comes on the back of a request from 22 Republican attorneys general for the FDA to look into the safety of the drug.

The Trump administration's jaw-dropping efforts to link autism to painkiller acetaminophen and childhood vaccines – described by former President Barack Obama this week as "violence against the truth" – raises big questions about the impartiality of the mifepristone review.

The review comes 18 months after the Supreme Court unanimously rejected a legal effort to restrict access to mifepristone spearheaded by a group of anti-abortion doctors and activists, which in turn followed SCOTUS' ruling to overturn the constitutional right to abortion.

With legal channels to advance the anti-abortion agenda on the drug seemingly blocked off, it seems activists now may be looking to a regulatory route. Earlier this year, Kennedy said he planned to launch an investigation into the safety of mifepristone, and Trump, along with many senior Republicans, has voiced opposition to abortion rights in the past.

In the letter, Kennedy and Makary say that since mifepristone's approval in 2000, the FDA has "received reports of serious adverse events in patients who took mifepristone." It also refers to a study by the Ethics and Public Policy Center (EPPC), a conservative and "Judeo-Christian" religious think tank that point to "potential dangers that may attend offering mifepristone without sufficient medical support or supervision."

That is viewed as a way to overcome an expansion of ways to access mifepristone in the wake of the loss of constitutional rights to abortion, such as allowing telehealth prescriptions, mail-order availability, and prescribing by certain healthcare professionals other than a doctor.

Brittany Fonteno, president and chief of the National Abortion Federation (NAF), said the study is "a junk science report from an anti-abortion think tank."

"RFK's attacks on science and his ongoing spread of disinformation around safe medications are reckless, alarming, and completely out of step with reality. The facts are clear: mifepristone is a safe, research-backed method to end a pregnancy, used by millions with proven efficacy," she continued.

"We know anti-abortion extremists will stop at nothing to ban or restrict access to abortion. They are willing to jeopardise patient health and autonomy to advance a political agenda and sow fear among people who need care."

Photo by Colin Lloyd on Unsplash