Is It Free Speech Or Off-Label Marketing?
5 CommentsBy Ed Silverman // September 4th, 2007 // 5:59 pm
That appears to be at issue in a group of eight putative class-action suits consolidated before a federal judge in Newark, N.J. What’s more, the litigation will be among the first cases to test whether drugmakers may face civil liability for promoting off-label uses, according to The New Jersey Law Journal.
The suits were filed against Schering-Plough following a $435 million settlement last year of civil and criminal charges brought by the federal government, which claimed the drugmaker paid kickbacks to docs and promoted drugs for unapproved uses. The plaintiffs are private drug users and third-party payers, such as unions and health insurance companies.
The civil suits charge Schering-Plough promoted off-label uses of hepatitis and cancer drugs, in some cases for longer periods or higher doses than needed. One alleged scheme involved paying docs up to $1,500 to participate in clinical trials for cancer meds that were never submitted to the FDA for approval.
A lawyer for the drugmaker says the defense will rely on what it considers a free-speech right to discuss off-label uses with docs, who aren’t restricted from prescribing drugs for purposes unapproved uses. Schering-Plough claims that 95 percent of oncology drugs are prescribed off-label and that off-label usage is also common for pediatric and psychological drugs.
“There is no allegation of a false or misleading statement by the company with regard to these drugs - all that is at issue is speech-related activities by company personnel,” Joan McPhee of Ropes & Gray in Boston tells the Journal. “This will be one of the first cases to test the question of whether you can have a cognizable civil claim about off-label prescriptions.”
Concerened MD
When it comes to a patient’s safety, there is no right to free speech on behalf of a drug company rep! These drugs carry a lot of risk. It is clearly a violation of FDA regulations and is enforced by the OIG and the OAG,
SP is famous for doing this over and over again. They will continue to do so until the fines hit them in the pocketbook and their senior management starts to be held accountable for authorizing such action. The ex-Pharmacia crowd did the same thing with off-label talk of HGH for anti-aging while at Pharmacia. it’s all in Peter Rost’s book.
Show me an SP marketing and sales plan and it’s bound to include activities that are not permited. It’s the way of the new SP, which is old Pharmacia in sheep’s clothing.
I hope somebody takes them down.
PR
FDA, OIG and OAG,
PLEASE TAKE NOTE OF THIS ACTIVITY AND AUDIT THE COMPANY ASAP! YOU”LL FIND THEIR FREE SPEECH TO BE RAMPANT!
IT’S THE SP WAY!!!!!
JD
This is the most ridiculous thing I’ve heard in a long time. How can these highly-compensated legal have the audacity to suggest that not allowing pharma sales reps to promote marketed products off-label is a violation of their right to free speech.
Never mind that the data has not been reviewed and approved by the FDA. Sales reps can spread false and misleading information to physicians (i.e., lie) because they have a right to free speech.
Pharma is a regulated industry. They can’t disobey the law because they don’t like it. Why don’t we just proclaim that all laws are optional. I think that Schering-Plough and their outside legal people have rocks for brains.
Next they plead innocent by reason of insanity - the pressure from Wall Street made me do it!
MD
You’re right on! This is exactly why I don’t see their reps anymore. I can’t believe what they say!! They treat doctors like a bunch of dummies!!
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