Hi everyone,
I am trying to educate myself on this issue. Is there a simple factual answer to the question?
Thanks for your help.
For those who don’t understand the question:
The Supreme Court agreed on Wednesday to take up a dispute over a medication used in the most common method of abortion in the United States, its first abortion case since it overturned Roe v. Wade last year.
The justices will hear appeals from the Biden administration and the maker of the drug mifepristone asking the high court to reverse an appellate ruling that would cut off access to the drug through the mail and impose other restrictions, even in states where abortion remains legal. The restrictions include shortening from the current 10 weeks to seven weeks the time during which mifepristone can be used in pregnancy.
I think it would have very limited relevance: perhaps some of the controlled substances where there are differences between some states and the federal government as to what should be legal?
It seems to take drug approval away from the experts at the FDA and put it into the hands of the courts. The appeals court is telling the FDA that it didn’t do the approval correctly and are putting their own rules in place. This is a very weird stance for a court to take, but here we are.
There won’t be many drugs as controversial as an abortion drug. Maybe courts will step in to overrule the FDA on some birth control drugs?
Well, one would hope, but look at all the anti-vaxxers.
Yes, I guess an anti-vax court could decide that it knows better than the FDA and say that they didn’t properly vet the vaccine and force it off the market.
The bottom line is that it’s unusual for a court to override the scientists at the FDA in such a specific way, I think.
IIRC there is some judicial notion that you cannot wait an unreasonably long time before filing a case. This is not a statute of limitations thing, more that if there is some objection to how something an agency did that lawsuit needs to be brought in some reasonable amount of time (maybe years). Mifepristone was approved in 2000. Twenty-three years is a long time to wait to claim what an agency did was wrong and that the drug is unsafe.
If the Supreme Court lets that go then pretty much anything is on the table for future litigation (not just against the FDA…pick an agency).
This court isn’t overturning the action that the FDA took in 2000, it’s overturning the action it took in 2016. That is, it’s keeping it legal, but tightening up how it can be prescribed.
Well this says:
The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication. - SOURCE
As a factual answer to the question, the SCOTUS’ decision can be as narrow or broad as the Justices want it to be. The conservative Justices are clearly on the warpath to undo the “administrative state.”
Their immediate goal is to overturn the Chevron principle that – when a statute is ambiguous – the courts should defer to the judgment of the administering agency on the reasonable interpretation of the statute. They’ve teed up Loper Bright Enterprises v. Raimondo this term specifically so they can revisit and likely gut Chevron.
I think that was the lower court decision. The appeals court overruled that, but still imposed its own conditions.
The New Orleans-based 5th U.S. Circuit Court of Appeals in August ruled that the post-2016 FDA decisions should be put on hold because the moves “were taken without sufficient consideration of the effects those changes would have on patients.” The court ruled against the challengers on their efforts to overturn the original approval of the drug and the later decision to authorize the generic version.
Cite.
A simple answer? Probably not. Contrary to some suggestions, judicial review of agency decisions is a standard component of our process – most “expert” agency decisions are subject to challenge in a court and can be overturned. There is a whole comprehensive body of law about this, touching on many areas. I don’t think anyone serious would suggest that judicial review is particularly weird in and of itself.
The issues here (and in many such cases) are: (1) who can challenge the decision (standing); (2) when you can challenge the decision (timeliness); (3) the lawfulness of the actual FDA decision; and (4) the remedy.
The answers to the first and second questions have the potential to affect other FDA decisions (and the review of other agency decisions). Whatever the answers are will guide future challenges (to drugs, but also numerous other areas).
The answer to the third question isn’t likely to have a broad effect – if (as the Fifth Circuit held) FDA did not consider (or explain) some key issue relevant to its decision, then it would typically get to look at it again and consider it (subject, again, to judicial review). That’s how agency rulemaking tends to work.
The problem is that then this process could presumably be applied to other drugs - if the FDA, for example, were to rule that a vet sheep-dip chemical could not be prescribed for Covid because it was totally ineffective, the manufacturer or some anti-vax nutbars could challenge that decision in court.
As I understand… The court is not ruling on whether the drug is safe or effective - just on whether the process of approving it was done with due consideration of the risks. Whether it’s safe or not, if the approval was done in a careless and risky manner or without due consideration of all the data, the approval would be ruled void.
What I don’t understand, is why the FDA could not simply re-examine the data, including new data since the original decision, and re-issue a new approval, rendering the current case moot. Rinse and repeat.
Thanks everyone. I’m hoping that other drug makers are going to pitch a fit and maybe make a difference in what happens here.
Mifepristone has been shown to be a safe drug yet the case seems to allege, among other things, the possibility it hasn’t been tested adequately by the FDA. In theory, someone could bring a case against aspirin. a drug that can actually cause some harm (stomach issues, etc.) and have the drug banned. Many drugs could easily meet this criteria - think of all the side effects mentioned on TV ads. The GOP doesn’t seems to care about this slippery slope and is willing to further remove doctors from our health care and replace them with politicians and judges.
Thanks for this. Helpful comments.
I vaguely remember when Chevron came out, but have never looked into it at all.
Link to the Wikipedia article for anyone who’s interested in further reading:
Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. - Wikipedia.
[Moderating]
On thinking about this further, this thread is speculating about possible implications on possible future court decisions, based on possible outcomes of a case that the Supreme Court has yet to decide. I think there’s at least one or two too many layers of speculation here for FQ.
Moving to P&E.
(You’re older than I realized). I don’t think this case has much to do with Chevron, which is essentially about who gets to engage in statutory interpretation.
This is about a challenge to an agency action under the Administrative Procedure Act, which allows a court to set aside an agency action which is “arbitrary” and “capricious.” Of course, few actions are actually arbitrary. So the review looks at whether the agency failed to adequately explain its decision, whether it relied on something impermissible or failed to consider something essential, or was contrary to law. Chevron gets implicated in the last category – if the agency misinterpreted the statute, its application thereof is likely to be “arbitrary.” But this case is purportedly about the other categories – whether FDA adequately considered all the relevant evidence in its decision-making.
Sad but true.
It was 1984. It ain’t all that old I don’t think. I was a junior in high school then.
One of the interesting differences between US and Canadian admin law is that at the federal level in the US, admin law is almost entirely statutory.
In Canada, at the federal level and for most provinces, admin law is mainly common law. There’s a couple of provinces that have passed admin law statutes, but they are classic common law statutes which alter the common law in some respects, but don’t replace the common law entirely.
In my province, for example, the substantive basis for admin law remains the prerogative writs, although they’ve been given the general name of “judicial review” for procedural purposes. Same at the federal level. “Certiorari” as the basis for judicial review has a completely different meaning here than in the US SCOTUS practice.