The specter of illegal marketing continues to haunt the pharmaceutical industry as Bristol-Myers Squibb agreed to a $19.5 million settlement with 42 states to resolve charges of improperly promoting an antipsychotic medicine several years ago.

The drug maker was accused of so-called off-label marketing, which refers to promoting a medicine for an unapproved use. In this case, Bristol-Myers allegedly touted Abilify to children, as well as elderly patients with symptoms of dementia and Alzheimer’s disease. However, the pill was not approved by the US Food and Drug Administration for the uses for which the company was targeting those populations.

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  • Most or all of these activities will now be legally protected free speech under the 21st Century Cures Act, as long as the promotion is restricted to insurance companies.

  • Hmmm – ‘… when new regulations may be issued …? Oh, how about within 30 days of the new Admins’ FDA Commissioner ‘ascending to his throne?’ Based on the soon to be signed ‘Cures’ bill, I am sure.

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