Is Big Brother Playing Fair With Pharma?

From Mike Myers, President, Palio (@mmyerspalio)

Big brother is definitely watching and more importantly further defining his role.

I had heard of the $81 million dollar fine/settlement that J&J had to pay for allegedly promoting Topamax (their anti-epileptic and migraine prevention drug) for off-label psychiatric uses.

But Ed Silverman over at Pharmalot was the one who let me know in one of his recent posts about the extent of the Corporate Integrity Agreement (CIA) between the Office of Inspector General and Ortho-McNeil-Janssen Pharmaceuticals.

J&J reps are now going to be accompanied by Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) Compliance Personnel or other designees on random sales calls. When conducted, sales reps will not be allowed to interact with physicians or any other healthcare professional without direct observation. At the end of the day, a report will be prepared to outline what happened, whether anything inappropriate occurred, and a general overall assessment of the rep’s compliance with appropriate promotional guidelines.

I don’t believe in off-label promotion. As a former sales rep, it was drilled into my head as the ultimate no-no. As an agency guy, we don’t support it either. It goes against what I personally and professionally feel is right.

And while the overwhelming majority of pharma personnel that I’ve worked with feel the same way, someone feels that everyone needs to hear the strength of this message. Basically, “we’re going to fine you and we’re also not going to trust you to follow what we agree is the right thing to do either.”

My 401K and our current economy are largely where they’re at as a direct result of business improprieties. And while I want people to toe the line and face regulation/scrutiny when they fail to do so, I’d also like pharma to be treated like other industries.

Frankly, the political reasons that politicians and their associated agencies utilize to justify vilifying pharma as the purveyor of all that is bad are wearing thin on me.

If what J&J must do to be compliant in the eyes of the government includes this level of scrutiny, then so be it. I’m all for it. But, when will the countless other industries and firms that have knowingly or unknowingly made mistakes be held equally accountable?

What do you think?