"...these managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law. Furthermore, these managers have also ordered, intimidated and coerced FDA experts to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements..."
"CDRH managers prefer to employ regulation-based 'pseudo-science' rather than science-based regulation."
Today's big FDA news concerns a letter written by eight scientists at CDRH. It is difficult to know which approvals or clearances they are referencing, as even the type of device has been redacted from the letter. The letter appears to be prompted by specific disagreements about specific device applications, but one could easily be forgiven for thinking that they may be addressing systemic problems when they use quotes such as those excerpted above.
As I mentioned in a previous post, there have been several simmering issues related to policitcal appointees playing a greater discretionary role in the enforcement of regulations. What is alleged in this letter extends well beyond stalling enforcement, however. It is one thing if FDA's reactions have been a bit lacking. We kind of expect that level of shenanigans. It's quite another matter if the perception takes hold that political pressure has compromised FDA's role as an independent evaluator. That is not going to sit well with just about anybody.
This is particularly relevant because of a potential landmark case currently before the Supreme Court, Wyeth v. Levine. This case is the latest round in the discussion of "preemption", the notion that FDA clearance of a product should preempt tort action under state law for harm caused by the product. This issue is more complex than the obvious partisan interpretations might suggest. If we want to reap the fruits of medical innovation and most medical treatments (particularly the innovative ones) carry some level of risk, simply demostrating harm shouldn't be sufficient grounds for a case. The potential for harm is well-known and accepted as a risk of obtaining a benefit. Assuming that, how does a reasonble actor determine if the harms are outweighed by the benefits?
Proponants of preemption rightly point out that it would be very difficult to create a state-by-state patchwork of risk/benefit calculations and we would be better to perform this assessment once at a national level. Since FDA review takes many of these exact issues into account, perhaps their determination is the highest-quality point of reference one can hope for.
In any event, preemption stands to increase the incentives to work with regulators, which is usually a good thing.
That said, there are also many arguments against preemption. Today's news exposes a pretty large additional weakness in the preemption argument.
Although FDA should (and, in my experience, ususally does) function as an impartial scientific body, there are serious hazards to placing more burdens on this process. The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations. I would hate to see the FDA become more like the judiciary. Hopefully, we can avoid an environment where high-stakes political appointments create volatility in the ongoing mission and needlessly politicize the practice of medicine.
Whatever the Supreme Court rules on that case, I think we can guess one thing for sure at this point: FDA will likely see a shift toward stricter enforcement, less leniency and more aggressive oversight. No announcements have been made, but a lot of writing is already on the wall.
I will be advising our clients to take another look at their risk assessments in light of a different regulatory climate. I'd advise anyone reading this blog to do the same.
Tags: CDRH, Enforcement, FDA, IVDMIA, Policy, Preemption
