U.S. Judge Exposes the Reek of Politics in the FDA’s Approval of Medication Abortion

What is the future of mifepristone? The Supreme Court may be forced into making another tough decision.

The drug mifepristone is currently responsible for more than half of all abortions in the United States. Now its legality is in doubt after two judges in different courts issued completely different rulings, both on April 7. The issue is clearly headed for the US Supreme Court, which has already found that there is no constitutional right to abortion. For the moment, the drug, mifepristone, is still available, pending appeal.

In Texas, federal judge Matthew Kacsmaryk declared that the Food and Drug Administration (FDA) had improperly approved mifepristone. He banned its use across the country. In the state of Washington, federal judge Thomas Rice ruled that mifepristone should be made available in 17 states and the District of Columbia. The uncertainty is obviously untenable.

The White House issued a fact sheet which described Judge Kacsmaryk’s decision as “dangerous” and said that the President “stands by FDA’s scientific and evidence-based judgment that mifepristone is safe and effective.”

The drug and biotech sectors were outraged. More than 400 leaders of drug and biotech companies—none of whom make mifepristone—signed a statement condemning the Texas decision. The statement said, “Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”

Media coverage of this dispute is a classic example of blinkered reporting on a divisive issue.

There was almost no analysis of merits of the judges’ legal arguments.

US District Judge Thomas Rice in Washington state, reported the Washington Post, is an Obama appointee. He worked as an assistant US attorney and then in the tax division of the Justice Department. That’s about as much as we know about his background.

The media did a lot more digging on US District Judge Matthew  Kacsmaryk. The New York Times quickly discovered that this hitherto-unknown judge had been appointed by President Trump, that he was a graduate of Abilene Christian University, that he had expressed pro-life views, that he was a conservative, that he opposed LGBTQ+ rights, and that he had worked for a conservative religious foundation, First Liberty Institute. “For Texas Judge in Abortion Case, a Life Shaped by Conservative Causes” was the headline. No word, though, on his favourite pizza — so much for the investigative powers of America’s paper of record.

Judge Rice ordered the federal government to ensure that mifepristone remains available in 17 states and the District of Columbia. I write as a legal layman, of course, but his reasoning seems unremarkable. He accepted assertions by attorneys-general of the states that “the status quo” should be preserved because women would experience severe, irreparable damage if they were unable to obtain abortion pills.

However, buried in his 31-page judgement is an extraordinary comment:

It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks …. That is precisely FDA’s role. However, based on the present record, FDA did not assess whether mifepristone qualifies for REMS and ETASU [special scrutiny] … Even under a deferential review, it appears FDA failed to consider an important aspect of the problem. Moreover, the record demonstrates potentially internally inconsistent FDA findings regarding mifepristone’s safety profile.

Great minds think alike. This is precisely the nub of Kacsmaryk’s argument. It is a damning indictment of the FDA. He did not use the word “corrupt”, but it springs to mind as he reviews the FDA’s disgraceful behaviour in approving mifepristone. He raises some uncomfortable questions for the abortion industry, the Biden Administration, Big Pharma, and the FDA. It begins:

Over twenty years ago, the United States Food and Drug Administration approved chemical abortion. The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right?

Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.

This is a key issue – and one which was barely covered in the media. For most journalists, abortion was settled long ago. It is the status quo. Which is precisely the point, contends Kacsmaryk. Delay created the status quo.

Chemical abortion is only the status quo insofar as Defendants’ unlawful actions and their delay in responding to Plaintiffs’ petitions have made it so. The fact that injunctive relief could upset this “status quo” is therefore an insufficient basis to deny injunctive relief.

In short, the FDA pulled every bureaucratic trick in the book to keep opponents of medication abortion from questioning the approval process – “sixteen years of delay, dawdle, and dithering”.

Kacsmaryk is a judge, not a pro-life activist, although he appears to be sympathetic to the arguments about the humanity of unborn children. He is supposed to assess cases on their legal merits. And that is what he did. He was scathing as he exposed some of the FDA’s stratagems for ensuring that mifepristone would be approved with almost no restrictions.

Take, for instance, the provisions of the Comstock Act. Though often criticised and ridiculed, it is still on the books. It declares that certain things cannot be sent by mail: “[e]very article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use…” [emphasis added]. The plain language of the law excludes distribution of medication abortion through the mail.

Consider also the fact that the FDA fudges its statistics about the dangers of mifepristone. Originally abortion doctors were required to report all non-fatal serious adverse effects of the drug. But in 2016, the FDA eliminated that requirement. “FDA repeatedly altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs,” writes the judge.

… it is circular and self-serving to practically eliminate an “adverse event” reporting requirement and then point to a low number of “adverse events” as a justification for removing even more restrictions than were already omitted in 2000 and 2016. In other words, it is a predetermined conclusion in search of non-data — a database designed to produce a null set. But even if FDA’s explanation[s] were well-reasoned, the actions would still run afoul of the Comstock Act …

Kacsmaryk concludes that the thread which runs through the FDA’s treatment of this controversial drug is truckling to political pressure:

The Court does not second-guess FDA’s decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased “access” to chemical abortion …

On April 7, the day the duelling decisions were handed down, the Oregon Attorney-General, Ellen Rosenblum, crowed on Twitter: “Don’t be too distracted by the breaking news out of Texas—we got a BIG WIN in the case led by Oregon and Washington (and joined by 16 other states).”

Opening the champagne may be premature. If this case goes to the Supreme Court – as seems likely — Kacsmaryk’s forensic dissection of the FDA’s games could be a template for the Roberts Court’s own findings. It exposes the shabby tricks that the FDA has been playing for years to defend an indefensible drug.

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