Birth Control and Vaccines Could Be Next If SCOTUS Upholds the Texas Ruling Against Abortion Medication
Upholding Judge Matthew Kacsmaryk’s decision would set a shocking, dangerous precedent.
BY BESS LEVIN
APRIL 11, 2023
https://www.vanityfair.com/news/2023/04/supre...fepristone
At some point in the very near future—possibly by Friday—the Supreme Court will be asked to weigh in on US district judge Matthew Kacsmaryk’s ruling invalidating the Food and Drug Administration’s 23-year-old approval of mifepristone, the drug used in about half of all abortions nationwide. (Kacsmaryk oh so generously stayed his own order for seven days, meaning mifepristone should remain available until then.)
Should the high court uphold the Trump-appointed judge’s ruling, it would be a devastating blow to abortion access nationwide—including in states where abortion is legal—and have a profound, life-altering impact on countless pregnant people. But upholding Kacsmaryk’s decision wouldn’t just affect mifepristone; it would, according to legal experts, give anyone seeking to get a particular drug removed from the market the opportunity to do so.
If that sounds like a really f--king crazy, extremely scary, and wildly ill-conceived idea, rest assured it is indeed all of those things. But will SCOTUS actually let Kacsmaryk’s ruling stand? Let’s take a closer look.
As The New Republic notes, there are significant problems with Alliance for Hippocratic Medicine v. FDA. For one thing, there’s the matter of timeliness: A six-year statute of limitations seemingly precludes challenging the FDA’s approval of mifepristone, which the agency green-lit more than 20 years ago.
(For his part, Kacsmaryk disagreed with the plaintiffs’ “logic” that the clock was somehow reset to 2021 after the agency denied a petition concerning a 2016 action by the FDA...and then he proceeded to act like the suit was valid anyway.) Another issue is the matter of standing to bring the lawsuit at all. As TNR writes:
While every lawsuit is different, they must all meet the same basic conditions or a judge will throw them out. One of those conditions is that whoever files the lawsuit must have the legal standing to bring it. People generally can’t file lawsuits to right wrongs on behalf of their friends, their neighbors, or total strangers. If you’re going to sue, you have to have a legal injury to do it. And if you’re going to sue based on something that might happen, you have to show that whatever you are theorizing might happen will almost certainly occur.
The Justice Department, which appeared on behalf of the FDA, told the Fifth Circuit Court of Appeals in a brief on Monday that the plaintiffs’ claims were too speculative and hypothetical to meet those thresholds. “Plaintiffs do not prescribe mifepristone,” the department noted in its brief. “Instead, they speculate that other doctors will prescribe mifepristone; that those doctors’ patients will experience exceedingly rare serious adverse events; that those patients will then seek out plaintiffs—doctors who oppose mifepristone and abortion—for care; and that they will do so in sufficient numbers to burden plaintiffs’ medical practices.”
We’re no lawyers, but that sure sounds like a pretty weak argument—and yet!
Despite this, Kacsmaryk concluded that this was enough for the plaintiffs to meet the standing threshold. His explanation largely consisted of restating the plaintiffs’ assertions without further analysis. At one point, he concludes that the plaintiffs have standing because they “allege adverse events from chemical abortion drugs can overwhelm the medical system.” It would be one thing if those claims were made about a brand-new drug that hadn’t been adopted on a national scale before. But if that were true about mifepristone, then the medical system would already be overwhelmed because it has been on the market for almost a quarter-century. Someone would have noticed by now.
If the Supreme Court effectively decides, in upholding Kacsmaryk’s ruling, that basically anyone at any time can bring a suit challenging some drug, medications that were approved decades ago—that have been proven to be safe and effective and that millions of people rely on—could suddenly be at risk because someone doesn’t like them. Perhaps you can think of a couple classes of drugs that might suddenly be on the chopping block in this scenario?
As is now particularly well established in American life, some drugs — vaccines, birth control — already have communities of people that oppose them. It’s all but a certainty that if standing is so expanded and the statute of limitations essentially disregarded, the FDA approval of these drugs will be immediately challenged.
Upholding Kacsmaryk’s decision “could allow virtually anyone to challenge any FDA drug approval decision with a good chance at succeeding,” William Schultz, former deputy FDA commissioner and Department of Health and Human Services general counsel, told TPM on Monday. In a letter published the same day, hundreds of pharmaceutical and biotech executives issued a similarly grave warning, writing, in part:
Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.
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. While the drug development, approval and monitoring process is not perfect, the Agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.
The one glimmer of hope is that, despite being stacked with creepy archconservatives who took great pleasure in overturning Roe v. Wade last year, Alliance for Hippocratic Medicine v. FDA may simply be too outrageous for the Supreme Court to go along with it.
As Vox correspondent and attorney Ian Millhiser wrote on Friday after Kacsmaryk’s ruling came out: “My best guess is that SCOTUS reverses Matty K in a 6-3 vote. This SCOTUS is awful. But I think that [justices John] Roberts, [Brett] Kavanaugh, and even [Amy Coney] Barrett probably understand that upholding this lawless order would be a declaration of war against the rule of law that they are likely to lose.”
Here’s hoping.
Upholding Judge Matthew Kacsmaryk’s decision would set a shocking, dangerous precedent.
BY BESS LEVIN
APRIL 11, 2023
https://www.vanityfair.com/news/2023/04/supre...fepristone
At some point in the very near future—possibly by Friday—the Supreme Court will be asked to weigh in on US district judge Matthew Kacsmaryk’s ruling invalidating the Food and Drug Administration’s 23-year-old approval of mifepristone, the drug used in about half of all abortions nationwide. (Kacsmaryk oh so generously stayed his own order for seven days, meaning mifepristone should remain available until then.)
Should the high court uphold the Trump-appointed judge’s ruling, it would be a devastating blow to abortion access nationwide—including in states where abortion is legal—and have a profound, life-altering impact on countless pregnant people. But upholding Kacsmaryk’s decision wouldn’t just affect mifepristone; it would, according to legal experts, give anyone seeking to get a particular drug removed from the market the opportunity to do so.
If that sounds like a really f--king crazy, extremely scary, and wildly ill-conceived idea, rest assured it is indeed all of those things. But will SCOTUS actually let Kacsmaryk’s ruling stand? Let’s take a closer look.
As The New Republic notes, there are significant problems with Alliance for Hippocratic Medicine v. FDA. For one thing, there’s the matter of timeliness: A six-year statute of limitations seemingly precludes challenging the FDA’s approval of mifepristone, which the agency green-lit more than 20 years ago.
(For his part, Kacsmaryk disagreed with the plaintiffs’ “logic” that the clock was somehow reset to 2021 after the agency denied a petition concerning a 2016 action by the FDA...and then he proceeded to act like the suit was valid anyway.) Another issue is the matter of standing to bring the lawsuit at all. As TNR writes:
While every lawsuit is different, they must all meet the same basic conditions or a judge will throw them out. One of those conditions is that whoever files the lawsuit must have the legal standing to bring it. People generally can’t file lawsuits to right wrongs on behalf of their friends, their neighbors, or total strangers. If you’re going to sue, you have to have a legal injury to do it. And if you’re going to sue based on something that might happen, you have to show that whatever you are theorizing might happen will almost certainly occur.
The Justice Department, which appeared on behalf of the FDA, told the Fifth Circuit Court of Appeals in a brief on Monday that the plaintiffs’ claims were too speculative and hypothetical to meet those thresholds. “Plaintiffs do not prescribe mifepristone,” the department noted in its brief. “Instead, they speculate that other doctors will prescribe mifepristone; that those doctors’ patients will experience exceedingly rare serious adverse events; that those patients will then seek out plaintiffs—doctors who oppose mifepristone and abortion—for care; and that they will do so in sufficient numbers to burden plaintiffs’ medical practices.”
We’re no lawyers, but that sure sounds like a pretty weak argument—and yet!
Despite this, Kacsmaryk concluded that this was enough for the plaintiffs to meet the standing threshold. His explanation largely consisted of restating the plaintiffs’ assertions without further analysis. At one point, he concludes that the plaintiffs have standing because they “allege adverse events from chemical abortion drugs can overwhelm the medical system.” It would be one thing if those claims were made about a brand-new drug that hadn’t been adopted on a national scale before. But if that were true about mifepristone, then the medical system would already be overwhelmed because it has been on the market for almost a quarter-century. Someone would have noticed by now.
If the Supreme Court effectively decides, in upholding Kacsmaryk’s ruling, that basically anyone at any time can bring a suit challenging some drug, medications that were approved decades ago—that have been proven to be safe and effective and that millions of people rely on—could suddenly be at risk because someone doesn’t like them. Perhaps you can think of a couple classes of drugs that might suddenly be on the chopping block in this scenario?
As is now particularly well established in American life, some drugs — vaccines, birth control — already have communities of people that oppose them. It’s all but a certainty that if standing is so expanded and the statute of limitations essentially disregarded, the FDA approval of these drugs will be immediately challenged.
Upholding Kacsmaryk’s decision “could allow virtually anyone to challenge any FDA drug approval decision with a good chance at succeeding,” William Schultz, former deputy FDA commissioner and Department of Health and Human Services general counsel, told TPM on Monday. In a letter published the same day, hundreds of pharmaceutical and biotech executives issued a similarly grave warning, writing, in part:
Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.
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. While the drug development, approval and monitoring process is not perfect, the Agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.
The one glimmer of hope is that, despite being stacked with creepy archconservatives who took great pleasure in overturning Roe v. Wade last year, Alliance for Hippocratic Medicine v. FDA may simply be too outrageous for the Supreme Court to go along with it.
As Vox correspondent and attorney Ian Millhiser wrote on Friday after Kacsmaryk’s ruling came out: “My best guess is that SCOTUS reverses Matty K in a 6-3 vote. This SCOTUS is awful. But I think that [justices John] Roberts, [Brett] Kavanaugh, and even [Amy Coney] Barrett probably understand that upholding this lawless order would be a declaration of war against the rule of law that they are likely to lose.”
Here’s hoping.
