A Decidedly-Serious Sunday Question: What Might FDA Do — About Brazenly Lawless… Monopolists?

Many know I’ve long followed Mr. Shkreli’s crime spree, at another property of mine. About ten days ago, Daraprim was approved by FDA, as a generic for Cerovene. That closed one of Martin’s remaining open loops. Here’s a bit, over several days, on that.

The opinion piece we mentioned on Saturday morning — from NDSU Asst. Prof. March — set me to thinking overnight:

Given that Martin Shkreli didn’t even bother to offer a facially plausible [and by that I mean an arguably lawful] reason — for (among other things) prohibiting sales of reference products, for testing, to would-be generic manufacturers… the FDA has very little in the way of remedies — to punish the wrong-doer, and release the drug for generic equivalency testing.

It seems, for five decades, the FDA in the main has been able to rely on the good faith of the industry. But with characters like Martin on the scene, that makes FDA’s job nearly impossible — without DoJ’s intervention. And bringing an action against monopolists takes a minimum of five years, in federal court — meaning generics are slow to reach market.

While Martin’s spree was perhaps an outlier, in its audacity — there are many big pharma companies smart enough, or well-lawyered enough, to cleverly articulate “safety” and/or purity arguments — and then (just the same!) discourage and delay reference drug supply deliveries… to the generic manufacturers for testing and ultimate approvals. But not outright ban the practice by contract.

This is a new world, then — with at least some larger pharma players no longer willing to play strictly by the rules, if only pricing/cost (as opposed to multiple patient deaths) hangs in the balance. [Should a chemical entity (generic) just be presumed equivalent, to speed generic approvals? I think that’s a dangerous idea — but without cooperative bulk supplies — from the branded company… adequate testing is well nigh… impossible.]

In those cases — by far the more prevalent version of the problem… it would seem new legislation will be needed.

But with both Rs and Ds largely in big pharma’s pocket… don’t hold your breath.

Moreover, all of 45’s bluster about getting generics to market, or reimportation from Canada… is just that: empty claptrap.

He has no intention of doing… any of it.

~~~~~~~~~~~ Earlier ~~~~~~~~~~~

Yesterday, I saw a purported expert on US drug pricing reform offer yet another poorly thought out opinion on Daraprim and Mr. Shkreli. He claims that since Martin was gone by late 2015, from what was called Turing, and then Vyera… and then became Phoenixus, the price was no longer his fault.

Poppy-cock.

Of course we now well know from the federal court filings that Martin left his minions behind to run the company and was still calling the shots even from prison [via his very substantial holdings of Phoenixus common voting stock] as late as mid 2019 via an illicit cell phone. We also know that he set up all the contractual pacts that prevented generic companies from getting the needed data to get FDA approval packets together. Oh — and he, until last week [and the generic arrival], saw his Phoenixus stockholdings profit from his own monopolistic moves — ones he didn’t even bother to give a facially neutral rational explanation for. Both of these facts this “expert” seems completely… cluefree about.

Martin is 100 per cent culpable [in my more well-thought-out opinion]… for the lawless machinery he created despite what this man says:

. . . .[R]ather than emphasizing the benefit to patients, many people [use the] news of [generic Daraprim and] the FDA’s [slow] approval as an opportunity to continue chastising Shkreli. MedCity News, a leading news source for healthcare markets, recently published an article entitled, “Sorry, Martin Shkreli: FDA approves first generic version of Daraprim.”

We might protest Shkreli’s actions as shameful. Many of his critics, however, seem to forget that Shkreli stepped down as CEO in late 2015. [Ed. Note: he had been indicted by then — and he left behind his minions Mulleady, et al., to do his bidding.] Daraprim still costs $750. If his successors haven’t lowered the price, how much blame can be placed on Shkreli? [Editor: all of it.]

…Daraprim’s story teaches us two lessons about pharmaceutical markets. First, when competition is stifled, producers raise their prices. Second, although there are many obstacles to making prescription drugs more affordable, the easiest way is to increase competition between drug producers. Most often, that involves generics. . . .

So the author cluelessly ignores the fact that it was Martin’s willingness to engage in conduct that violates the Clayton and Sherman Acts at multiple companies [locking down the needed Daraprim samples — to CREATE the generic data package for FDA approval of a generic]… that prevented FDA from approving a generic until now.

That is just… a very poor excuse for… actual critical thinking.

Onward to a workout, and fun — with baby girl, this afternoon, at the park!

नमस्ते

There are no comments on this post.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: