1 year ago
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Reproductive rights are once again under attack in the United States as Federal Judge Matthew J. Kacsmaryk recently ruled in a Texas district court to suspend the FDA’s approval of the abortion pill mifepristone, overturning decades of robust scientific research involving millions of people.
The court decision has already been condemned by a wide variety of stakeholders, including the FDA, the Biden administration, medical institutions including the American Medical Association and the American College of Obstetricians and Gynecologists, editorial boards of newspapers including the Los Angeles Times and the Wall Street Journal, and more than 400 pharmaceutical executives and investors.
US Attorney General Merrick Garland has confirmed that the Justice Department will ask the Supreme Court to intervene, saying, “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
A volatile situation as high courts weigh in
The US Court of Appeals for the 5th Circuit has now temporarily blocked Judge Kacsmaryk’s ruling. But, in that process, the federal appeals court also sidelined the best available science by reinstating an outdated set of restrictions that significantly restrict access to mifepristone.
The appeals court ruled that the FDA needed to at least temporarily roll back a series of science-based regulatory decisions that the agency has made since 2016. Because of that decision, patients’ ability to receive mifepristone through the mail now stands in jeopardy. And because the decision ordered the mifepristone label to revert to a version approved in 2000, health providers who wish to offer mifepristone beyond seven weeks of pregnancy (the FDA had approved the medication for use up to 10 weeks) must now resort to what is known as off-label prescribing—a common practice, but one that could bring increased scrutiny in the current climate.
This appeals court decision prompted the Justice Department to file an emergency application to the Supreme Court on Friday morning, asking the highest court to intervene and pause parts of the appeals verdict limiting the availability of mifepristone to the public. Late on Friday, Justice Samuel A. Alito Jr. granted the Justice Department’s request but only until midnight Wednesday. This gives patients and health providers full access to the drug until then, but these measures are woefully temporary and it is uncertain what access patients can expect to have to mifepristone in the weeks ahead.
Court ruling ignores scientific evidence
The details of Judge Kacsmaryk’s ruling are unsettling in so many ways. And Judge Kacsmaryk’s history clearly shows his political and personal biases against reproductive rights, some of which he tried to hide during his senate confirmation.
It is clear that his ruling does not consider the best available science. As a result, it can set the stage for further undermining the FDA’s authority to approve and regulate medications.
In his ruling, Judge Kacsmaryk contends that the FDA “acquiesced on its legitimate safety concerns—in violation of its statutory duty” and he raises, without serious evidence, the charge that the agency “faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
The statements are breathtaking in their absurdity, and could only be made by someone willfully ignoring the actual scientific evidence. As I detailed in a previous blog post, there is a veritable mountain of scientific evidence showing that this drug is safe and effective, which is further confirmed by data from the five million people who have safely taken mifepristone since 2000. Some studies show that mifepristone is even safer than medications such as Tylenol or Viagra. One could hardly have picked a worse drug to attack based on its safety profile.
In fact, the FDA has been steadily reducing restrictions to access to mifepristone in recent years based on the scientific consensus of the drug’s safety and effectiveness. This January, for instance, the agency announced its approval of a plan to certify pharmacies to dispense mifepristone. This is precisely how the process is supposed to work. The agency is supposed to restrict or ban drugs where the weight of scientific evidence shows them to be harmful, and increase access to needed drugs where the weight of scientific evidence shows them to be safe.
We can already see that Judge Kacsmaryk’s reasoning is not universally shared by others in the federal judiciary. Within an hour of the ruling’s release, a federal judge in Washington state, Judge Thomas Rice, issued a ruling on another case that came to the opposite conclusion. Judge Rice ordered the FDA not to make any changes restricting access to mifepristone in the 17 states and District of Columbia that filed the suit.
Drug approval must be based on best available science
I do not want to live in a world where a medication is approved or banned by a single individual. None of us should be subjected to such a world.
Since the 1938 Food, Drug and Cosmetic Act, Congress has given the FDA the authority to rule on the safety and efficacy of drugs. As part of this often arduous and extensive process, drug companies must conduct a series of animal studies and human clinical trials to provide enough solid scientific evidence to the agency that a drug is a safe and effective treatment for a disease or a medical condition.
Judge Kacsmaryk’s ruling risks setting the horrifying precedent of undermining the FDA’s authority, potentially setting in motion future legal and potentially politically motivated challenges to the agency’s ability to regulate a wide variety of medications and medical devices. The ruling not only poses a threat to women, girls, and non-binary and transgender individuals who can become pregnant, but also to anyone who believes that the FDA’s science-based approach is essential for approving and assessing medications.
The ruling interjects opinion and bias into a process that should be guided by science. It could make the approval of medications you and your loved ones need subject to the whims of future litigants. And given that this issue is now likely to be decided by a Supreme Court that issued numerous anti-science rulings last year, it can feel like a dark and uncertain time.
But this is not how things will end. We at UCS will continue to fight back against anti-science forces and press those in positions of power to protect people’s health and safety using the best available science, evidence, and science-based decisionmaking. The stakes are simply too high to do anything less.
