Our March cover story looks at the potential growth of pharma cGMP whistleblowing, and features interviews with qui tam lawyer Ken Nolan of Nolan and Auerbach, FDA compliance expert John Avellanet, consultants Johnny Guerra and Michael Gregor, as well Neil Getnick and Lesley Ann Skillen, who represented Cheryl Eckard in her epic case. Mr. Avellanet, Ms. Skillen and Mr. Getnick, as well as Mr. Nolan will speak in a webcast series starting April 7 on that topic.
The key to avoiding cases like this, they agree, is corporate accountability, and, as far as data integrity is concerned, a plan. One memorable quote from Ms. Skillen:
"Those critics who complain that whistleblower lawsuits are undermining corporate compliance programs have it backwards. Instead, it is ineffective compliance programs that are undermining the ability of employees to have their well-founded concerns about unethical and illegal corporate conduct properly addressed…without resort to a lawsuit."
These days, there continues to be little positive news in the pharma compliance area....As you all know, the J&J/McNeill case recently reached its inevitable conclusion in the form of a consent decree naming the VP's of manufacturing and Quality.
We need to maintain some sense of humor despite all the negatives....In his LinkedIn group, Friends of Modernization in the Drug Industry, Hedley Rees has promised a copy of his latest book to anyone who writes the best song lyrics on some aspect of drug industry supply chain management (or mismanagement as the case may be). Some of us can't resist an opportunity to be corny. Here's one contender set to Paul Simon's "50 Ways". Join Hedley's group and send in your lyrics...
50 Ways to Bad Outsourcing (The Heparin Song)
The problem's all inside your head, it dawned on me.
The profits easy, if you see it logically
Let’s outsource to where... there are no GMP’s
There must be 50 ways to diss your workforce….
The future of this market will be all in BRIC
New plans set for Europe or the U.S. make me sick.
Think outside the box.
Partners are waiting, take your pick.
There must be 50 ways to diss your patients.
Let’s go Kazakh, Jack
Been to Kyrgyzstan, Stan?
Or maybe Hanoi, Roy
Just get yourself free
Hop on the bus Gus
Don’t need to discuss much
Just drop off the key Lee
And get yourself free…
Three years later, head of QC, came to me
She said , you acted rashly, too bad no one made you see.
We invested where, they have no grip on quality.
Countless ways to screw SOPs
She said It grieves me so to see you in such pain
This consent decree is costly, and the recalls come again
When it’s done, you get stock options. But what happens to my name?
50 ways to diss employees
Slip out the back Jack
Make a new plan Stan
Don’t need to be coy Roy
just get yourself free
Hop on the bus Gus
Don’t need to discuss much
Just drop off the key Lee
And get yourself free…
AMS
