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Category Archives: Off Label Marketing

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FDA may step up criminal prosecutions for off-label marketing

Posted in Off Label Marketing

This is promising: Drugmaker executives whose companies promote unauthorized uses of their medicines may be targeted by U.S. regulators for misdemeanor prosecutions, Food and Drug Administration Deputy Chief for Litigation Eric Blumberg said. * * * * ‘“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows… Continue Reading

Rituxan Lawsuit Filed On Behalf Of Quadriplegic

Posted in Misc. Drugs, Off Label Marketing

Some people don’t understand why pharmaceutical companies shouldn’t be allowed to engage in off-label marketing.  Here’s one reason: Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the… Continue Reading

GlaxoSmithKline Sales Rep Bonuses Are Tied To Values, Not Sales

Posted in Off Label Marketing, Pharmaceutical Advertising

I’ll be honest with you. I don’t trust pharmaceutical sales reps.  Few of them are medical doctors, but they tell doctors which drugs should be prescribed for which patients.  Traditionally, their compensation is based in part upon how many drugs the doctors they visit prescribe.  This leads to a gigantic incentive to engage in off-label… Continue Reading

Will there be a crackdown on pharmaceutical data mining?

Posted in Off Label Marketing, Pharmaceutical Advertising

I sure hope so.  Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use. Washington Bureau – When your doctors writes you a prescription, that’s just between you, your… Continue Reading

AstraZeneca Agrees to Pay Over Half a Billion Dollars For Offlabel Marketing of Seroquel

Posted in Off Label Marketing

Another good article from Duff Wilson at the New York times. The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel. One of the investigations related to “selected physicians who participated… Continue Reading

Risperdal Sales Rep Was “Probably” Aware He Was Illegally Promoting Off-Label Use

Posted in Off Label Marketing

I’d love to get my hands on the transcripts for this case. Oct. 28 (Bloomberg) — A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses. Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said… Continue Reading

Is this the beginning of the end of the off-label marketing ban?

Posted in FDA Regulation, Off Label Marketing

If Allergan is successful in challenging this rule, then FDA approval will become meaningless.  Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use.  Some would say that’s the world we already live in… Oct. 2 (Bloomberg)… Continue Reading