FDA Left Unaccountable For Abortion Drug Harms

Ever since the U.S. Food and Drug Administration removed basic safeguards on high-risk abortion drugs, women have been suffering. Many women who take these drugs are told to expect mild pain, only to be shocked by the excruciating experience of an at-home abortion without any in-person care or visits with a doctor to let them know when emergency care is necessary. Women deserve better.

Unfortunately, women will continue to be harmed by what the FDA has done, for now. On June 13, the Supreme Court declined to address the merits of a case brought against the FDA over its removal of basic protections for women taking abortion drugs.

My organization, Alliance Defending Freedom, represented frontline doctors who are witnessing firsthand the harms inflicted by the FDAs reckless removal of commonsense protections, like in-person visits to check for ectopic pregnancies. While its disappointing that the Supreme Courts decision didnt address the FDAs reckless actions and that women will continue to suffer, we are grateful that three states stand ready to hold the FDA accountable, since they are not precluded from moving forward with litigation.

That accountability is important because, when the FDA first approved abortion drugs in 2000, it required doctors to provide ongoing care to women using the drugs, including in-person visits to check for ectopic pregnancies, severe bleeding, and life-threatening infections. Yet in a pair of highly politicized decisionsfirst in 2016, then in 2021the FDA endangered womens health by stripping away those requirements for in-person care. Indeed, data the FDA cites shows that hospitalizations increase over 300% with no in-person doctor visit.

But putting the abortion industrys bottom line over womens health, the FDA has left women to perform their own abortions at home or in their dorm rooms without critical medical attention and relying on emergency-room doctors, like those we represent, to care for anticipated complications.

Abortion drugs are not safe. The FDAs own label has long warned that roughly one out of 25 women who take them will end up in the ER, and documents show that 7% will require surgery. But the FDA removed its original safeguards anyway. Thus, since the removal of these safeguards, our doctors have seen a huge surge in women experiencing complications and needing their care. That was no shock to the FDA, which acknowledged that women harmed by these drugs would need to rely on emergency rooms instead of the prescribers who gave them the drugs, despite how overwhelmed emergency rooms already are.

In a telling moment at oral argument before the Supreme Court, the abortion drug manufacturer Danco admitted that its primary interest in this case was its profits. When Justice Samuel Alito asked Dancos attorney to explain what injury the company would suffer if the FDAs original safeguards were re-applied, she answered, We are prevented from selling our product. So much for caring about womens health.

Both the federal district court and the circuit court agreed with us that the FDA should be held accountable for endangering womens health. Women who had suffered from the FDAs recklessness felt they were finally heard and hoped the FDA would do its job so no more women experience the excruciating pain and isolation of an at-home abortion. But, at oral argument, the U.S. solicitor general concerningly claimed that nobody, not even the frontline doctors who treat and care for women harmed by abortion drugs, can challenge the FDAs removal of common-sense protections.

While the FDA managed to avoid accountability on a legal technicality in this case, the states of Missouri, Kansas, and Idaho are ready to step in to hold the FDA accountable for jeopardizing the health and safety of women and girls. No federal agency is above the law, and women deserve the in-person care of a doctor when taking high-risk drugs.

So, while the agency may have gotten away with endangering womens health for now, this lawsuit backed the federal government into a corner. The governments initial position was that federal law would not protect our doctors from being forced to participate in abortions. But, at the Supreme Court, the government changed its position and said that federal conscience laws protect doctors in these circumstances. And the court agreed, emphatically stating in its 9-0 decision that [f]ederal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.

Its encouraging that the court broadly affirmed conscience rights for medical professionals. But that doesnt change the fact that the agencys removal of commonsense safeguards for women using abortion drugs is as wrong today as it was before. ADF and the doctors and medical associations in this case will continue to stand for womens health and expose the reckless actions of the FDA while the states continue their fight in the lower courts.

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Gabriella McIntyre is legal counsel with Alliance Defending Freedom ( @ADFLegal ), which represents four doctors and four medical associations in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine .

The views expressed in this piece are those of the author and do not necessarily represent those of The Daily Wire.