Access To Drugs Elevated Above Regulatory Policy On Safety And Agency Accountability
FDA Made Mistakes And Pro-Choice Advocates Relied On Retrograde Arguments
There Are Reasons Big Pharma Is Blasting The Decision
[Update – 6/13/24 – we predicted exactly this outcome:
[Update below]
I strongly support a woman’s right to choose, and have not followed the long controversy over FDA approvals, but I did recently read the Texas decision striking down FDA approval of the abortion inducing drug mifepristone.
There are surprising regulatory things in that Texas decision (that explain why Big Pharma has gone ballistic) and I find it incredible that the progressives are openly advocating Executive Branch defiance of a federal court.
I found several contradictions and deep ironies in that decision.
Over my 40 year career, I’ve always pushed the envelope on regulation of public health, environment, and safety risks. I’ve consistently urged regulatory agencies to conduct the most conservative credible interpretations of the science and data, and demanded rigorous regulatory review, under the “precautionary principle”. Key principles I’ve supported include transparency and broad administrative law procedures to assure public access to hold government and corporations accountable (administratively and in courts).
So, basically, I was shocked that progressive pro-choice advocates seemed to be advancing retrograde arguments about regulatory policy and public health and safety protections, while a right wing pro-corporate judge was relying on progressive preventative health and regulatory oversight and risk management principles.
As someone who has filed and strongly advocates for regulatory petitions, I was surprised to learn that the case originated in a regulatory petition to FDA by an anti-abortion group.
(Note: does anyone remember that environmental groups successfully petitioned EPA, a move that forced EPA regulation of greenhouse gas emissions?)
The Texas FDA decision begins with the judge blasting FDA for an extremely long delayed response to that petition: (emphasis in original)
Why did it take two decades for judicial review in federal court? …
Simply put, FDA stonewalled judicial review – Before Plaintiffs filed this case, FDA ignored their petitions for over 16 years, even though the law requires an agency response within 180 days..
That is just totally unacceptable and indefensible. No way would environmental groups tolerate a 16 year delay. No way.
I really don’t know enough about the science issues to write intelligently about them, but in just now reading a politically oriented piece on that decision by a favorite lefty historian writer Paul Street, I felt adequate to engage a few ill informed points he made on the substance of the Texas decision. Read Street’s superb piece:
Here’s my note to Paul, which explores some of the contradictions and ironies:
Paul – a couple of points in response (and of course I strongly agree with your political argument about electoral versus street activism):
1. Reading the Texas decision, it seems clear that the pro-choice movement long ago made a strategic choice to quietly pursue drug induced abortion – which could take place in the privacy of the home, not the visible abortion clinic – for many of the same cowardly liberal conflict avoidance postures that led them to not demand street protest.
2. I’ve spent my career in environmental regulation, so am quite familiar with the science and administrative procedures and legal challenges at issue in the Texas decision. And how industry and right wing judges manipulate them all. So, what’s happening here is that Big Pharma is attempting to craft an exception to traditional administrative law. What they are saying is that we’re different and should not be subject to the same judicial and public scrutiny and legal challenge. On their behalf, the FDA brief asserted all sorts of retrograde, pro-corporate legal barriers to citizen access to the Courts, e.g. standing, statute of limitations, burdens of proof, judicial deference, et al. These are all frequent industry arguments to attack EPA regulations.
3. You have made the same retrograde legal arguments to attack a very bad decision – you make those arguments in this excerpt, which I will rebut point by point:
“Kacsmaryk’s ruling is based on thoroughly false, fake-scientific allegations about mifepristone’s safety and defied the six-year statute of limitations on challenges to FDA decisions. It ignored the anti-abortion plaintiffs’ lack of standing and flouted the Supreme Court’s decision in Dobbs returning abortion law “to the states.””
a. In term of “fake science” – did you read the decision? Did you note that FDA eliminated adverse health effects reporting requirements for all but death? That makes it impossible to have reliable data. If FDA or EPA did that on other risks, the public health and environmental communities would go ballistic. Some of the data that is available (and I read a GAO Report that verified the data in the opinion, so it is not “fake”) is shocking in terms of health risks. Yes, the mortality risk from the drugs is an order of magnitude LOWER than normal pregnancy, but that is not a valid benchmark, as there are serious non-fatal effects and the background rate of mortality in pregnancy is WAY too high.
There is also a very interesting science based regulatory argument that the safety conditions under the FDA safety clinical trials were not mandated by FDA use and labelling requirements. If that argument holds, big Pharma is SCREWED. This has HUGE implications for FDA regulatory review of vaccines and drugs.
Regardless of the risks, it seems obvious to me that pro-choice advocates convinced FDA to elevate access above safety (based on a 1992 law enacted in response to the AIDS crisis to expedite FDA review and approval). That is a very bad policy and would never obtain support for other drugs or environmental risks. Public health and regulatory science are supposed to follow the precautionary principle and “first do no harm”.
b. Statute of limitations – aside from being a retrograde legal argument and barrier to citizen access to the courts and accountability for regulatory agencies, there is a legitimate legal argument that FDA reopened the regulatory proceeding. This is not a slam dunk either way.
c. standing – same retrograde legal argument at SoL.
d. “return to States” – that is pure legal bullshit and even your prior writing on Dobbs says so. Don’t you remember when you wrote that the real agenda was to enact a national ban on abortion? (i.e. via CONGRESS). Dobbs did NOT return the abortion decision to the states, it eliminated a constitutional right and said that LEGISLATURES (Congress and State) could regulate and restrict abortion.
Finally, FDA took many years to respond to a regulatory petition that they are legally required to respond to in 180 days. This is the kind of administrative foot dragging bullshit I fight all the time. Agencies use delay to hope tough decisions will just disappear. No way environmental advocates who petition EPA would stand for that crap. Again, very retrograde arguments are being used to support the pro-choice case.
I thought you were a little smarter than that and would never swallow corporate and right wing legal arguments.
That right wing pro-corporate nut job Texas judge relied on some liberal legal and public health arguments – and that’s the irony here.
[End Note: Paul Street actually wrote this absurdly false statement, a claim I’ve heard repeatedly made:
If the ruling is backed by the US Supreme Court, a single far-right arch-reactionary among the nation’s 673 district federal judges will have been absurdly granted the power to trump the regulatory power and science-based judgement of the FDA. There is no precedent for such a dark possibility. …[…]
Federal courts have been rejecting science-based regulatory judgements of federal agencies for decades.
[Update: 4/17/23 – Just read an amicus brief from “FDA legal experts” (filed by beltway elite law firms who often represent Big Pharma) and they are not shy about putting their cards on the table. Here’s what it’s all about:
Plaintiff’s proposed remedy would profoundly undermine the well-established statutory and regulatory framework for the approval of new drugs and the due process accorded to drug marketing application holders by statute. It would also create harmful reverberations that would affect patients, healthcare providers, and the biopharmaceutical industry, all of whom rely on the expertise of FDA to make scientific determinations regarding the safety and effectiveness of our nation’s medical products. … […]
… overriding FDA’s safety and efficacy determination and forcing FDA to withdraw a longstanding drug approval would profoundly undermine the statutory and regulatory framework underpinning the approval of new drugs, thereby threatening patient access to therapeutics and chilling industry research and development. … […]
FDA has the scientific and medical expertise to make the complex determinations necessary to ascertain safety and effectiveness, including determinations regarding clinical trial design, dosing, and labeling. Here, Plaintiffs ask the Court to override FDA’s safety and effectiveness determinations and force it to withdraw an approved application for a drug that has been on the market for more than 20 years. Such an order would “seismically disrupt the agency’s governing authority as to whether drugs are safe and effective.” Danco’s Opp’n 1. It would also be unprecedented: We are not aware of any case in which a court has removed a drug from the market over FDA’s objection.
The effects could extend far beyond mifepristone. No drug is without risk, and a ruling for Plaintiffs could lead to challenges to FDA’s benefit-risk determinations for drugs it has approved to treat other diseases and conditions. Patients who rely on life-saving medications could see their drugs removed from the market with little notice.
Additionally, Plaintiffs’ remedy, if granted, would create widespread uncertainty in the pharmaceutical industry and chill research and development. FDA is the sole U.S. agency with which industry engages on issues related to drug review, approval, and labeling changes. Manufacturers are familiar with the FDCA and FDA’s regulations and procedures, and they invest in clinical research and costly clinical trials against the backdrop of that framework. If courts can unilaterally overturn safety and effectiveness determinations, manufacturers would simultaneously have to navigate a patchwork of judicial decisions regarding what is required for drug approval. This would fundamentally confound the expectations of industry, leave manufacturers vulnerable to challenges to their currently marketed drugs, and discourage investment in research and development of new drugs.
Profits are on the line! BOOM!
An additional sharp legal irony is that this case presents huge conflicts for the Supreme Court.
Everyone knows the Court strongly opposes abortion.
Because of how the Texas decision was written, the case also provides an opportunity for the Court to enforce it’s views on limiting judicial deference to administrate agencies (reversing the “Chevron” doctrine, a key element of the right wing ideological attack on “the administrative state” ) (Amicus)
FDA repeatedly has acted in accordance with the FDCA and its implementing regulations in making scientific determinations that mifepristone meets the safety and effectiveness standards set forth in section 505 of the FDCA (21 U.S.C. § 355). FDA’s approvals of mifepristone therefore should stand. See Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) (“[J]udgments as to what is required to ascertain the safety and efficacy of drugs fall squarely within the ambit of the FDA’s expertise and merit deference from us.”).
But the court is pro-corporate. If the Supreme Court follows the attack on FDA discretion, it would hurt Big Pharma.
Big Pharma does not want federal courts reversing or taking hard looks at FDA decisions, because Big Pharma has captured FDA and their regulatory decisions PROMOTE Big Pharma profits.
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.