Tuesday, July 26, 2016

Slightly Refining My June 1, 2016 Predictions -- On Potential Supreme Court Drug-Makers' First Amendment Case(s) -- Thanks To My Commenter(s)

[Do go read the comments over the weekend, if you need the full back story, here.] My commentary, in reply:

I agree Anon. -- and no worries -- about tangents, here.

This entire website is one seven and a half year tangent, originally decrying some abuses of FDA (and SEC) rules, by one Fred Hassan -- the ex-CEO of legacy Schering-Plough. Smile.

As to Merck's GC (as noted on June 1) -- I've long felt that a delicate balance need be struck, between drug makers' commercial speech rights (which under long standing US Supreme Court precedents may be limited as to "time, place and manner(s)"), and the generally broad language of our first amendment.

Certainly, safety and accuracy should come first -- i.e., be paramount -- when a merchant speaks about "inherently dangerous" drugs and biologics (to use some 19th Century Cardozo court language) -- if mis-used.

I will go out on a limb and predict that when our 45th President [a Democrat who orchestrated proposals (in 1992) for the series of reforms that ultimately became the ACA of 2010] is sworn in come January 2017 -- and then she, in fairly short order, fills at least two Supreme Court seats -- we will see the High Court's support for "renewed vigor" in enforcing the FDA's rules limiting manufacturers' off-label touting, and other promotional notions.

I now think FDA may see expanded, as opposed to contracted authority, here. And thanks to you, I'll make a new post of it, in a moment.

Do stop back by -- thanks for the thoughts -- travel well; but travel light.

And the comment that led most directly to these revised thoughts:

July 26, 2016 at 6:34 AM -- By: Anonymous.

. . .I feel it pertinent to note how this guidance letter potentially dovetails with what 'struck [you] as news-worthy' in your June 1, 2016 posting. In your referenced Bloomberg Law article, Merck's position on first amendment speech appears, at first glance, that pharmaceutical companies can say whatever they want about their products. However, taken at face value I do not feel that what Holston is implying should be afforded [as law], if recent history may serve as a guide.

In a 2005 article appearing in the New York Times, Dr. Sandra Kweder, acting director of the FDA's center for Drug Enforcement and Research, was quoted within the context of lessons learned from negotiating labeling with Merck for their blockbuster selective COX-1 inhibitor, Vioxx. In this article Kweder said that the power to change a label "would be very helpful."[1].

I hope what we are witnessing here is the FDA attempting to re-gain some 'teeth' in carrying out basic duties with which we as a public have continuously expected from this Public Health Service Division.


[1] Harris Gardiner (2005) FDA Official Admits 'Lapses' on Vioxx. New York Times.

1 comment:

Anonymous said...

What Kweder probably meant is change the label (which is generally ignored) rather than be required to take the drug off the market.