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Thanks to the FDA, women can take high-risk drugs without ever being seen by a health-care provider and physically examined for dangerous contraindications such as ectopic pregnancy.

by | Mar 18, 2024

By Erin Hawley

It’s always interesting when something that shouldn’t be all that interesting suddenly becomes extremely interesting to people who are not easily interested.

Recently, the academic publisher Sage retracted three studies from one of its journals. Ordinarily, retractions like these would not be newsworthy outside of the scholastic community, but in this case, some media outlets jumped at the chance to cover them. Why?

Because the studies were about abortion drugs — in fact, the exact drugs the U.S. Supreme Court will be hearing a case about on March 26.

The media will be happy to tell you all about the retractions, but they may not tell you one crucial fact: None of these studies will be at issue as the Supreme Court considers the case.

What is at issue in this case — the culmination of a lawsuit filed by my team at Alliance Defending Freedom — is the FDA’s systematic removal of safety standards for the abortion drugs mifepristone and misoprostol.

To win before the Supreme Court, we don’t need to rely on any of the retracted studies. In fact, all we need to rely on are the data that the FDA itself cites and the concessions it makes about those data. So why are the media so interested in the Sage studies?

Remember what this case is about: the FDA’s removal of safety standards for abortion drugs, an agency action that reached a crescendo in 2021 when the FDA eliminated the requirement that the drugs be dispensed during an in-person office visit.

This means that women can take these high-risk drugs without ever being seen by a health-care provider and physically examined for dangerous contraindications such as ectopic pregnancy.

That change marked a major departure for the agency. Under the Administrative Procedure Act, the FDA is required to “examine the relevant data and articulate a satisfactory explanation for its action.” Let’s examine what the FDA did in this case.

To justify removing the in-person office visit, the FDA relied on statistics from an internal database called the FDA Adverse Event Reporting System [FAERS]. The system allows health-care professionals, consumers, and manufacturers to report adverse events, but the FDA admits that “FAERS data does have limitations.”

Here’s a big one: After 2016, FAERS reporting is voluntary — no one is required to submit anything other than deaths. And for those who do submit reports, no one is required to verify anything, much less prove causation. That’s why the FDA says that the data cannot be used to predict how often adverse events will occur. But that’s exactly what the FDA did when it removed the in-person office visit.

Even without FAERS, however, the FDA’s rationale fails. It turns out the agency also relied on literature reviews that cover the dispensing of abortion drugs by mail. The agency argued that the literature “supported” its decision to remove the drug’s safety standards.

But what exactly does “support” mean?

The FDA found the studies were not “inconsistent with” its seemingly preordained conclusion that removing the in-person visit was safe. In other words, the FDA didn’t argue that the literature agreed with its position — only that it didn’t disagree. Not exactly the strongest endorsement, especially for a decision as weighty as removing safety standards for powerful drugs.

Bottom line: The FDA simply didn’t have the studies it needed. What it did have was evidence suggesting, in the FDA’s own words, that “there may be more frequent [emergency department]/urgent care visits related to the use of mifepristone when dispensed by mail from the clinic.”

In other words, studies indicated that removing the in-person office visit would lead to more emergency care — and as many as one in 14 women would need unplanned emergency care. This is notably higher than the FDA’s prior recognition that roughly one in 25 women who take these drugs end up in the emergency room.

How’s that to reassure women considering these high-risk drugs?

The FDA is certainly within its rights to reassess safety standards and change its mind. But it must provide “satisfactory explanations” for doing so. Flawed FAERS data and misused scientific literature are not satisfactory. They barely even constitute explanations.

The FDA’s rationale for removing its prior safety standards for abortion drugs fails on its own terms. To evaluate the merits of the case before the Supreme Court, don’t look to the Sage studies. Look to the FDA’s concessions and admissions and make your own conclusions. They may prove . . . interesting.

Editor’s note. Erin Hawley is senior counsel and vice president of the Center for Life and Regulatory Practice at ALLIANCE DEFENDING FREEDOM (@ADFLEGAL), which represents four medical associations and four doctors challenging the U.S. Food and Drug Administration for its removal of critical safeguards for women taking abortion drugs.

Categories: Abortion Pill