Over His Dead Body
Public Citizen’s Support of FDA Contradicts Dr. Wolfe’s Legacy Of Challenging FDA
[Update below]
Right now, I’m reading the Supreme Court decision on mifepristone (the abortion pill). Justice Kavanaugh wrote the opinion, see:
https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf
That case could have been a vehicle for the Supreme Court to reverse the “Chevron deference” doctrine.
But, I correctly predicted that the Court would find a technicality as a way to wiggle out without addressing the merits, because to again block abortion and reject Chevron deference would seriously hurt Big Pharma (and further undermine the Court’s reputation following the prior decision to reverse Roe v Wade and terminate a woman’s right to an abortion). I concluded:
I will predict that the Court will find a way to uphold the Texas decision partially, allowing the restrictions to stand in anti-abortion Red States, but they will do so in a way that does NOT allow stricter judicial scrutiny of FDA decisions.
[Update 6/20/24 – Here’s how the NY Times confirms that:
The ruling ensures, for now, full access to the drug, which is used in the majority of abortions in the United States. But it does not unravel restrictions on the pill in more than a dozen states that have passed near-total abortion bans since the court overturned Roe v. Wade. ~~~ end update]
And that’s exactly what they did in rejecting the challenge for lack of standing, see:
Could you imagine the outraged response if the Supreme Court blocked a public health group’s like Public Citizen’s challenge of FDA regulatory failure for lack of standing?
Or an environmental group like Sierra Club lawsuit to stop logging for lack of standing? The Court rubbed salt in an historic wound:
Like an individual, an organization may not establish standing simply based on the “intensity of the litigant’s interest” or because of strong opposition to the government’s conduct … “no matter how longstanding the interest and no matter how qualified the organization,” Sierra Club v. Morton, 405 U. S. 727, 739 (1972).
Or climate activist group like 350.org lawsuit to stop a pipeline for lack of standing?
The Court even provided a related hypothetical:
Consider some examples. EPA rolls back emissions standards for power plants—does a doctor have standing to sue because she may need to spend more time treating asthma patients? …
The answer is no: The chain of causation is simply too attenuated.
Is that a liberal view of science and standing?
Would Dr. Wolfe and these groups accept the Supreme Court’s description of their work as:
Article III requires, and that courts do not opine on legal issues in response to citizens who might “roam the country in search of governmental wrongdoing.”
How would they feel about having their work dismissed like this:
The injury in fact requirement prevents the federal courts from becoming a “vehicle for the vindication of the value interests of concerned bystanders.” An Article III court is not a legislative assembly, a town square, or a faculty lounge.
And we thought liberal groups supported widespread access to the Courts.
Do advocates of drug safety and the public interest agree with this:
Because the plaintiffs do not prescribe, manufacture, sell, or advertise mifepristone or sponsor a competing drug, the plaintiffs suffer no direct monetary injuries from FDA’s actions relaxing regulation of mifepristone. Nor do they suffer injuries to their property, or to the value of their property, from FDA’s actions. Because the plaintiffs do not use mifepristone, they obviously can suffer no physical injuries from FDA’s actions relaxing regulation of mifepristone
Getting back on topic.
I’ll make another prediction: The Supreme Court will reverse the Chevron doctrine – that they could have used the mifepristone FDA decision to do – in the upcoming cases that raise the Chevron deference issue (on a NMFS fishing monitoring fee case, a case out of Cape May NJ). And I’ll bet that Kavanaugh or Gorsuch will write it!
In doing research on mifepristone just now, I learned that Dr. Sidney Wolfe (no relation, but a longtime hero of mine, a Naderite, and with Public Citizen) died in January.
Reading his Obit, there’s an inventory of a mountain of work he did on FDA regulatory and scientific failures, see:
Sid invented a new approach of “research-based advocacy” to get dangerous drugs and devices off the market, win new protections for worker health and safety, address doctor misconduct, challenge the Food and Drug Administration (FDA) to do its job, and hold pharmaceutical companies accountable.
Dr. Wolfe’s major accomplishments touted include:
- Testified before hundreds of FDA advisory committees urging against approval of dangerous drugs and devices, and for limited use or strong warning labels of others, with substantial influence over countless decisions and helping prevent many dangerous products from ever making it to market.
- Documented weakening standards at the FDA following passage of the first Prescription Drug User Fee Act, which made drug companies a major revenue source for FDA.
- Won earlier public access to safety and efficacy information for products being considered for approval by the FDA, enabling more effective advocacy by consumer advocates.
In direct contradiction of the latter achievements of Dr. Wolfe, the Court dismissed public information concerns about risk:
the medical associations suggest that FDA is not properly collecting and disseminating information about mifepristone, which the associations say in turn makes it more difficult for them to inform the public about safety risks.
Would Dr. Wolfe support a regulation that only required reporting of adverse impacts limited to death?(Supreme Court):
(FDA) changed prescribers’ adverse event reporting obligations to require prescribers to report only fatalities
But, rejecting Dr. Wolfe’s legacy of challenges to FDA science and regulatory integrity, on mifepristone, Public Citizen filed an Amicus in support of FDA.
The basis for that support was as follows:
“In the court of appeals, Public Citizen filed an amicus brief on appeal in support of reversing the district court’s ruling. The brief explains that the FDA approves a new drug or modifies restrictions on an existing drug’s use only after a team of doctors, chemists, microbiologists, statisticians, pharmacologists, and other experts has conducted an in-depth analysis of a vast body of technical evidence of the drug’s safety and efficacy, including peer-reviewed scientific literature and the results of clinical trials conducted with oversight from disinterested institutional review boards. Given the rigor and reliability of this process, the FDA’s decision to deny a citizen petition that—like the one in this case—neither identifies a meaningful procedural flaw in the FDA’s process nor relies on new evidence showing lack of safety or effectiveness should rarely be overturned. […]
In the Supreme Court, we filed an amicus brief on behalf of Public Citizen and Center for Science in the Public Interest, again focusing on the rigor of the drug approval process, the high level of expertise that goes into FDA decisions about approval and regulation of specific drugs,”
Wow. “the rigor of the drug approval process, the high level of expertise that goes into FDA decisions”
Over Dr. Wolfe’s dead body.
Remarkable hypocrisy, no?
We’ll followup when the Chevron deference opinion is handed down in the coming days.
[End Note: Justice Kavanaugh clearly understood the implications. He tipped his hand – I guess he could not help himself and sent a message of support to protect Big Pharma with this:
And in the FDA drug-approval context, virtually all drugs come with complications, risks, and side effects. Some drugs increase the risk of heart attack, some may cause cancer, some may cause birth defects, and some heighten the possibility of stroke. Approval of a new drug may therefore yield more visits to doctors to treat complications or side effects. So the plaintiffs’ loose approach to causation would also essentially allow any doctor or healthcare provider to challenge any FDA decision approving a new drug.
Kavanaugh even went so far as to suggest that no one might have standing to sue FDA:
Finally, it has been suggested that the plaintiffs here must have standing because if these plaintiffs do not have standing, then it may be that no one would have standing to challenge FDA’s 2016 and 2021 actions. … even if no one would have standing, this Court has long rejected that kind of “if not us, who?” argument as a basis for standing. … The “assumption” that if these plaintiffs lack “standing to sue, no one would have standing, is not a reason to find standing.”
And Kavanaugh seemed to take pleasure in and went out of his way to remind everyone of the fundamentally anti-democratic role of the courts:
The Framers of the Constitution did not “set up something in the nature of an Athenian democracy or a New England town meeting to oversee the conduct of the National Government by means of lawsuits in federal courts.” Richardson, 418 U. S., at 179; see Texas, 599 U. S., at 685.
[Update – 6/17/24 – An important fact in this case that has not been reported by the media is that the doctors filed a petition for rulemaking to FDA on mifepristone. FDA failed to respond to the petition for almost 20 years. That delay frustrated judicial review of FDA regulatory decisions.
I mention this now because I just read a NY Times story about a petition for rulemaking to FEMA by environmental and labor groups, see:
The petitioners plan to litigate the matter if FEMA again denies the request.
Could you imagine FEMA failing to respond for 20 years, like FDA did?
And do you think the press would not report that failure, as they have failed to report the FDA failure?
And that environmental groups would support FEMA despite that failure?