Wednesday, June 1, 2016

Merck GC -- In Interview -- Hints At A "More Active Role" In Off-Label Regulatory Revisions, And DTC Discussions -- Underway In DC

Rather a minor point, here -- but I suppose it is worth noting, if for nothing else -- for a complete record. . . . so here goes.

Merck's very able GC gave an interview published today by Bloomberg -- and most of it covers well-known narratives -- at least to our regular readers (you know who you are!).

The concluding bit struck me as news-worthy, as we've said very little about Kenilworth's role in the ongoing FDA regulatory discussions about truthful, but technically "off-label" speech -- and whether, at some future point, when the Supremes are once again singing with a full-throated nine member chorus -- we might see some first amendment arguments win the day, there (against FDA assertions of regulatory authority). Here's the bit from Bloomberg, this afternoon -- but do go read it all:

. . . .Today, I’d say, internationally, one of the areas we’re paying the most attention to is the protection of our intellectual property rights. You’ve seen challenges in certain countries to respecting the intellectual property rights of pharmaceutical companies, and that’s a big issue. It remains an issue in the United States as well.

And then there are issues around the First Amendment, in terms of what pharmaceutical companies and medical device companies are allowed to say about their products. There’s been a lot of litigation in this space in the last year or two. . . .

We have not, Merck, directly been involved in it, but it’s obviously an area of significant interest. We are trying to help shape the conversation down in Washington, D.C., around those issues. . . .

Fascinating. As ever, we shall see. Off to enjoy a perfect late-afternoon, here. Keep it spinning in good karma, one and all. . . .

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