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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

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.

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‘“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Source: Drugmaker CEOs May Be Targets for U.S. FDA in Off-Label Cases, Lawyer Says – Bloomberg

However, I would go one step further.  As a matter of public policy, I would prevent pharmaceuticals from paying for the legal defense of anyone who is charged with criminal off-label promotion.  Let’s face it – the DOJ doesn’t have the best track record in the world in complicated prosecutions.  And the reason the DOJ isn’t winning more cases is because multibillion-dollar companies are able to provide the best defense money can buy.

If pharma executives had to pay the cost of their own defense, two things would happen.  First, executives would be less likely to engage in conduct that might get them criminally prosecuted.  Second, the DOJ wouldn’t be outgunned by multimillion-dollar dream teams.