Case in point: two new reports looking at off-label use of the hemophilia drug NovoSeven and two soon-to-be-released studies comparing the off-label use of Avastin vs.
The prohibition on off-label drug communications has likely caused unnecessary pain to patients, especially those suffering from cancer and HIV who could benefit from off-label drug and therapy uses.
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Because making any promotional statement regarding the off-label use of a drug constituted, at the very least, a criminal misdemeanor offense, pharmaceutical companies spent millions of dollars annually on compliance and training programs to deter and detect off-label promotion by sales representatives.
The Second Circuit agreed with Caronia and became the first court in the nation to hold that truthful and non-misleading off-label promotional speech is constitutionally protected under the First Amendment and, as a corollary, that off-label promotional speech would not constitute a criminal offense unless the speech was false or misleading.
Paul Wicks, a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.
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But by banning off-label drug speech, doctors have fewer chances to become aware of these applications.
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The FDA gives doctors that discretion as long as the off-label use seems reasonable.
There had been an expectation that the agency might try to limit off-label use.
Other drugs marketed off-label, including Natrecor and Invega, also reportedly are included in the settlement.
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That could make it easier for doctors to get data about so-called off-label uses for a drug.
Off-label use usually gets talked about when companies find way to encourage doctors to prescribe medicines inappropriately.
In the marketing of Xyrem, Orphan Medical pushed off-label uses for which there was no scientific support.
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Temodar is being used off-label to treat newly diagnosed patients, and extends the survival rate by eight weeks.
Every injury caused by an inappropriate off-label Rx was written by a physician, not by a sales rep.
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This ban on off-label communication is an offense to both American patients and American notions of free speech.
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Pfizer has paid hundreds of millions of dollars in fines for its off-label marketing of the drug.
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And the review gives Medicare plenty of ammunition not to pay for off-label, or unapproved, uses of Provenge.
Prescribers could also be given advice on prescribing medicines that are not licensed for children - so-called "off-label" prescribing.
In 2008, the latest year studied, researchers found such "off-label" uses accounted for 97% of orders for the drug.
Texas Governor Rick Perry is the latest beneficiary of so-called off-label medical therapy.
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It says there is no evidence supporting the drug in off-label uses, such as in sicker or healthier patients.
Companies spent billions more to settle allegations of off-label promotion with the government.
Dr. Yank and her colleagues used a database of hospitalizations to estimate national patterns of off-label use of the drug.
For instance, most use of Celgene 's (nadsaq: CELG - news - people ) Thalomid is off-label.
The tactic worked, the plaintiffs said, with Aetna paying for 43 million off-label doses of the drug between 1995 and 2004.
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It will be interesting to see if online clinical-trial registries provide another way of getting data about off-label uses to doctors.
Making that statement may be important to Medicare because the agency does traditionally pay for some off-label uses of cancer drugs.
But the NCD also contained a specific provision that prevented reimbursement for off-label uses unless patients were enrolled in clinical trials.
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Punishing the off-label use of cognitive enhancers may also be unfair to those who find these drugs medically useful in unexpected ways.
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Caronia is game-changing if it becomes prevailing law because, for decades, the prohibition on off-label speech shaped how pharmaceutical companies did business.
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