Saturday, May 11, 2013

Quick Additional Thoughts -- On The Scope Of FDA's Regulatory Charter

A friendly, and long-standing, commenter mentioned a link below -- and I thought I'd post my answer, embellished a bit, as a new Saturday morning post, here. It amplifies this, of mine, from last Saturday, on Merck's winning Liptruzet® FDA approval.

Yes -- I did see that. Ed Silverman is a really sharp guy. He's right -- as is the guy he quotes -- who wrote for Forbes, on the same notion, on Thursday evening. I'm debating about whether I need to say more on the topic than I said last Saturday morning.

I do agree that the FDA risks denting its now largely-repaired reputation, here.

There was a time, during the second Bush-Cheney administration, when many (if not most) long-time industry watchers/insiders felt that industry had essentially acheived FDA "regulatory capture". That is, many felt that industry was able to subtly (but effectively) influence FDA's agenda -- due to high profile placements of former pharma insiders, in FDA policy-setting roles -- over the course of a decade. I personally never really worried that patient safety was being compromised, but I did worry that in some cases pharma marketing was trumping the soundest science. FDA wasn't asking "is this the MOST effective drug?" -- in a given class. But there was, and is, a perfectly benign reason for that. See below, for that.

With Mr. Obama's election, then, a fair portion of the "marketing" regulatory capture drew to a close, in my estimation. FDA today is far more transparent -- and more responsive -- to public health needs than it has been in decades (perhaps going all the way back to its halcyon days -- in the 1960s).

Having said that -- and personally wishing that FDA would actively look at "comparative effectiveness" when approving new drugs -- I do know that, strictly speaking, FDA's regulatory authority ends at "is it an effective and safe medicine?". . . not at "is it the MOST effective drug out there?"

While there are proposals to draft comprehensive comparative effectiveness regulations, under various parts of the ACA of 2010 -- these remain proposals, not law (yet).

So -- the experienced realist in me accepts that FDA would be likely have been sued by Merck, had FDA not approved Merck's Liptruzet -- its latest cholesterol management combo -- for exceeding FDA's currently-authorized regulatory portfolio.

And so -- as I wrote seven days ago, I think we have to count on the market-place, to make sure Liptruzet sees only very limited adoption.

As Ed said (but do go read it all):
. . . .Merck has been running the 18,000 patient IMPROVE-IT trial, but results are not due until September 2014. . . .

This prompts a question –- what happens if the results are unfavorable? Well, Merck is left with a pair of cholesterol pills generating flat to declining revenue. Even if the IMPROVE-IT trial results are favorable, the drugmaker faces a different dilemma, because the Vytorin patent expires in 2017. By winning approval for Liptruzet, Merck has found a way to overcome the odds.

This is where the skepticism and cynicism kicks in. In its announcement, Merck acknowledged that Lipruzet did not offer any “incremental benefit on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin” (read here). In other words, patients and physicians should not expect the combination pill to offer any advantage in reducing the chance of developing heart disease. . . .

This is a difficult -- and still very gray -- area. And, from Merck's perspective, in my opinion, Merck was just completing the last little bit of a huge legacy Schering-Plough spend, on the chance that IMPROVE-IT vindicates such combos.

Thanks so much for mentioning it, directly, Anon. Saturday mornings are always luminous, if not entirely clear, here. Even so -- I'm inclined to trust the nation's good doctors -- to figure this one out.

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