So now we have another couple of twists in the Catalyst/Jacobus story (for background see these earlier posts). Jacobus, now that their version of amifampridine (3,4-diaminopyridine) has been approved by the FDA, has announced their price for the drug. And it’s definitely not the price they had before, which was free to the few people who needed it, but it’s still below what Catalyst has been proposing to charge. Jacobus is at $80 per 10mg tablet, which is less than half the Catalyst announced price. That’s what the FDA’s reward system is set up to deliver, whether they intended it or not.
But there are complications: no one is sure whether Jacobus actually has the infrastructure to deliver on the product now. One has the impression that the previous distribution was sort of a mom-and-pop operation, but hey, they’re a real drug company now with an FDA-approved drug, so everything has become much more complicated and expensive. Adding to the confusion is that Catalyst yesterday announced that they were suing the FDA for having approved the Jacobus drug at all.
Catalyst says that the agency is basically encouraging off-label use with that approval (Jacobus is approved for pediatric patients, and Catalyst is approved for adults), and that the approval was “arbitrary, capricious, and contrary to law”. My own take is that regulatory agencies can be arbitrary and capricious while remaining completely within their legal mandate – that’s what makes government so much fun – and that the FDA was within their authority to approve the Jacobus product in the way that they did. Should they have? That’s another question, but that’s not one that a court of law is going to be able to address.
Approving the same drug, from two different manufacturers, for different indications is indeed a bit odd. But I don’t see where it’s illegal. And US law most definitely allows for off-label prescriptions, at the discretion of physicians (and at the discretion of insurance companies, etc., to pay for them). So the biggest issue that Catalyst has to argue doesn’t (to me) look like something that they’re going to be able to make much headway on. Now, outside of the letter of the law, we have another argument: did the FDA approve the Jacobus submission in the way that they did in order to try to mitigate what they did by approving the Catalyst one under their incentive program to approve old compounds?
I think they probably did – but there’s certainly no way to prove that. And again, even if they did, the legal reply would probably be “Yep, and they can do that. Next!” But it’s true that it doesn’t increase anyone’s confidence in a government agency to see them acting like this, either, and I think that (in general and in the long term) it’s a bad thing for the FDA or any government agency to be seen as capricious and willing to bend accepted practice around when it suits them. No matter how satisfying one might find any individual decision. Eventually the rules become suggestions, and the laws all have an unspoken coda of “unless you don’t really feel like it”, and that’s no good, either. I don’t think this Jacobus approval does much harm, but (from that standpoint) it certainly doesn’t do any good, either. I felt the same way during the Pfizer/Allergan takeover fight, even though my sympathies for Pfizer otherwise are pretty minimal.
We already have a problem with having so many laws and regulations that compliance becomes a full-time occupation (see the IRS and OSHA for canonical examples, and there are plenty of others). Eventually you reach a point where everyone can be found to be in violation of *something*, and you live at the sufferance of the authorities, who might change their minds at any time. And this is a slow slide into an extortion racket: that’s a nice little business you have going there. . .wouldn’t want someone to come along and enforce Section 89(q) Part 14 all of a sudden, now would you? Real libertarians consider me a fair-weather friend, but this sort of thing really does get me going.
Of course, the cause of all this Jacobus/Catalyst brouhaha is the regulatory state that we have already. But here’s where I do part company with the radical-libertarian fashion, whose answer to this is “Well, ditch all that stuff”. I don’t want to ditch all that stuff. I think that doing so would be an invitation to even worse behavior, probably because my opinion of what people are capable of getting up to is a rather low one. What I want, instead, is for the law and the regulations to continue to improve as new issues challenge them. I think the FDA bungled things by rewarding companies too richly for being willing to take ancient compounds through a modern trial, and they’re coming close to bungling things again in a veiled attempt to make right the unintended consequences of that one.