Off-Label Drug Marketing Threatens Patients. It Could Soon be Legal.

A new class of pain relievers called Cox II inhibitors burst onto the U.S. market in the 1990s and quickly became blockbuster best sellers.

One reason was the marketing. The drugs arrived as federal officials were relaxing traditional standards that blocked most advertising aimed at consumers.

But it wasn’t only patients who were getting the hard sell. Recently released documents show that drug companies also were bombarding doctors with information about potential uses for the drugs, including some uses for which the medications had not been approved.

That’s illegal. Since 1962, pharmaceutical companies have been required to prove that their drugs are safe and effective for specific uses. Marketing drugs for unapproved, or “off-label” uses, is a criminal offense.

That may be about to change. Allergan, Inc., the company that makes Botox, has sued the U.S. Food and Drug Administration, claiming that the ban violates its free speech rights. The case is scheduled for a hearing later this month.

Read more: http://www.stltoday.com/stltoday/news/stories.nsf/editorialcommentary/story/7242B8EDE96A2A79862577050082F594?OpenDocument
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