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Tag: Glaxo

Is the Era of Off-Label Promotion Over?

The question arises in the wake of yesterday’s news that the government and GlaxoSmithKline settled a string of lawsuits charging the company with illegal promotion of prescription drugs for unapproved uses. The $3 billion settlement represented just a small fraction of the sales to patients for whom the off-label prescriptions either caused harm or did little or no good.

Glaxo’s chief executive Andrew Witty, in a prepared statement, assured the public that his company has “fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”

Judging by the number of seminars and conferences over the past few years designed to help companies meet the legal requirements for promoting drugs, there would certainly appear to be a lot more attention being paid these days to staying within the law. There have been 165 settlements between the government and drug companies over the last two decades, and the more recent settlements — $2.3 billion from Pfizer and $1.4 billion from Eli Lilly — have achieved blockbuster status (a word usually reserved for drug sales above $1 billion). While that is affordable for the highly profitable industry, settlements of that size do tend to capture the attention of top company officials and begin to tip the risk-reward ratio for illegal activity toward better compliance with the letter of the law.

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