If the TX judge’s ruling ends up prevailing on this one medication where:

He conducted his own assessment of the drug’s safety, contrary to courts’ historical deference to the FDA’s scientific determinations — and in this case, a drug for which all available data since its approval in 2000 demonstrate its safety and effectiveness.

Then any one medication or category of medications could be taken off the market from the “research/opinion of a judge – most likely a a person with only a doctor of jurisprudence  degree.” and could basically NEGATE 10+ yrs of clinical trials that it takes to get the FDA approval to bring a new medication to the market.  Since most/all R&D involving clinical trials to get a med approved by the FDA to bring to market.

The Mifepristone Battle: The Supreme Court Steps In

https://www.medpagetoday.com/opinion/the-health-docket/104061

FDA’s regulatory authority hangs in the balance

On Friday, Supreme Court Justice Samuel Alito put on hold rulings by a federal district court judge in Texas and by the Fifth Circuit Court of Appeals that would have severely restricted access to mifepristone (Mifeprex), an abortion medication used as part of a two-pill regimen to terminate pregnancies through the first 10 weeks of gestation. Alito’s orderopens in a new tab or window is intended to pause the current legal chaos and maintain the medication’s status quo while the Supreme Court has time to review the rulings from the lower courts. His order lasts until Wednesday night, and he has instructed the litigants to file their brief by noon on Tuesday.

So, how did we get here and what can we expect going forward?

 

 

On April 7, Matthew Kacsmaryk, a federal judge in Texas, suspended the FDA’s approval of mifepristone in a preliminary rulingopens in a new tab or window. Kacsmaryk stayed his order for 7 days.

Less than an hour after Kacsmaryk’s decision, a federal judge in Washington State issued a contradictory rulingopens in a new tab or window. Judge Thomas Rice ordered the FDA to do nothing to restrict access to mifepristone in 17 states and the District of Columbia, jurisdictions that filed a lawsuit against the agency over its risk evaluation and mitigation strategy (REMS) program for the medication.

In essence, a judge in Texas directed the FDA to remove mifepristone from the market and a judge in Washington directed the FDA not to impose further restrictions on that drug — requiring the FDA to march north and south at the same time.

That’s untenable. Given the accelerated pathway of the Texas case to the Supreme Court, we will focus our attention on that ruling.

The Texas Ruling

In November 2022, the Alliance Defending Freedomopens in a new tab or window (ADF), a conservative Christian legal advocacy group that works to expand Christian practices, challenged the FDA’s approval of mifepristone on safety grounds on behalf of its clients, the Alliance for Hippocratic Medicine coalition and other anti-abortion physicians.

Last week, Kacsmaryk issued a ruling in which he said that the FDA failed to consider safety concerns “based on plainly unsound reasoning and studies that did not support its conclusionsopens in a new tab or window.”  He conducted his own assessment of the drug’s safety, contrary to courts’ historical deference to the FDA’s scientific determinations — and in this case, a drug for which all available data since its approval in 2000 demonstrate its safety and effectiveness.

When taken as part of the two-pill regimen, mifepristone successfully terminates the pregnancy over 99%opens in a new tab or window of the time and has an extremely low risk of major complications (0.4%opens in a new tab or window) and mortality (0.0001%opens in a new tab or window). Ironically, the Trump-appointed judge with a history of opposing abortion and of judicial activism, claimed that “significant political pressure” caused the FDA to forego a rigorous safety check to advance the agency’s “political objective” of increased access to medication abortion.

Medical associations expressed concern that Kacsmaryk’s ruling “introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisionsopens in a new tab or window.” Hundreds of executives from the pharmaceutical and biotech industries stated the “decision ignores decades of scientific evidence and legal precedentopens in a new tab or window.” Professional organizations and pharmaceutical companies strongly condemned the Texas ruling, stating that it undermines FDA authority, reduces access to a safe drug, and could impactopens in a new tab or window all FDA approved products.

The Path to the Supreme Court

The Department of Justice (DOJ) immediately appealed Kacsmaryk’s order to the conservative Fifth Circuit Court of Appeals, arguing against the judge’s “misguided assessment of the drug’s safetyopens in a new tab or window.” On April 12, the three-judge panel of the Fifth Circuit issued a rulingopens in a new tab or window that overturnedopens in a new tab or window Kacsmaryk’s order suspending FDA’s mifepristone approval, explaining that the plaintiffs failed to file the lawsuit within the 6-year statute of limitations. However, the Fifth Circuit ruling upheld Kacsmaryk’s order to suspend FDA’s actions that expanded access to mifepristone from 2016 onwards, including extending eligibility for mifepristone from 7 to 10 weeks’ gestation, allowing retail pharmacies to dispenseopens in a new tab or window mifepristone, eliminating the in-person dispensing requirement (allowing it to be delivered by mail), and permitting non-physicians to prescribe or administer it.

Two days later, on Friday, April 14, the DOJ and Danco Laboratoriesopens in a new tab or window, which manufactures brand name mifepristone, both asked the Supreme Court to halt the injunction. Danco said it faces an “untenable lingo” of competing court orders and “regulatory chaos.” Meanwhile, ADF announced it would not appeal the Fifth Circuit ruling maintaining FDA’s approval of mifepristone, but would vigorously defend the decision to block post-2016 expanded access to the drug.

Alito’s temporary administrative stay on the Texas ruling avoids a nightmare scenario where pregnant individuals would have immediately lost access to a highly safe and effective medication. If the Supreme Court extends the administrative stay, and ultimately rules in favor of the FDA, the entire Texas decision would never take effect. That would be a win for reproductive health, for science, and the Biden administration.

The Supreme Court set all of this in motion in overturning Roe v. Wade in the Dobbs decisionopens in a new tab or window. The high court is no friend to reproductive choice and has demonstrated a willingness to strike downopens in a new tab or window federal regulatory action. Yet, even for a highly conservative Supreme Court, this case may be a bridge too far. The easiest path for the court is not to review the case on the merits at all. It could sidestep an analysis of the FDA’s regulatory authority by overturning the Texas decision based on plaintiffs’ lack of standing — the concept that a plaintiff must show that the challenged conduct caused them actual injury. And after all, the plaintiffs are not directly harmed by expanded access to mifepristone. Even if the court does analyze the FDA’s regulatory authority, the justices should recognize the profound effect that overturning the agency’s decisions would have on public health going forward. Furthermore, the justices understand the impact that upholding the Texas and Fifth Circuit’s decisions could have on all FDA approved products, and likely don’t want to open the floodgates of litigation against FDA decisions.

Even a 6-3 conservative super-majority should, in theory, ultimately side with science and the FDA. Yet, the ultimate outcome is far from certain.

Effects on Access to Mifepristone and Other Drugs

Upholding and enforcing the Fifth Circuit’s preliminary ruling would result in devastating consequences for many people of reproductive age. Medication abortions now account for more than halfopens in a new tab or window of all abortions in the U.S. Restricting mifepristone use beyond 7 weeks’ gestation would curtail access to essential reproductive health services for many pregnant people, many of whom do not know they are pregnant so early on. Reinstating unnecessary requirements, such as in-person office visits, would severely restrict access. Some would resort to dangerous self-managed abortions. Others would not be able to access the recommended treatment for miscarriages, which occurs in a third of all pregnanciesopens in a new tab or window. Overall, the Texas and Fifth Circuit rulings jeopardize the health, and even life, of pregnant persons. The highest risks will be disproportionately borne by low-income individuals and those living in rural areas, especially racial minorities, in states that virtually ban abortions.

Beyond reproductive health, the decision sets a dangerous precedent for future lawsuits that may contest approvals or regulatory decisions. In a new context where the FDA’s reputation for evidence-based drug approvals is no longer respected and courts no longer defer to its scientific determinations, numerous medications and vaccines could be at risk. States could try to pick and choose which FDA-approved products to permit, regardless of decades of robust evidence regarding their safety and efficacy.

Does the public trust FDA’s career scientists to determine the safety and efficacy of vaccines and drugs, or do they trust judges to do so? To ask the question is to answer it.

 

Filed under: General Problems