Pharma industry pushing for a First Amendment right to market its drugs for off-label uses

Drugs, Greed and a Dead Boy

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The recent court decisions could erode the F.D.A. approval process — put in place to protect the public — and threaten public health and patient safety,” warns Dr. Margaret Hamburg, until recently the Food and Drug Administration’s commissioner.

Children with emotional or mental disorders have become a gold mine for the drug industry. Psychiatric medicines for children account for billions of dollars in sales annually, and the market has boomed.

And now the industry is getting even greedier. It is pushing for a First Amendment right to market its drugs for off-label uses… …pharmaceutical executives see it as a tool to market drugs for unapproved uses.

In a recent column, I recounted how Johnson & Johnson deceptively marketed an antipsychotic medicine called Risperdal, concealing for example the fact that it can cause boys to grow large, pendulous breasts (one boy developed a 46DD bust). J&J got caught, pleaded guilty and paid more than $2 billion in penalties and settlements — but also registered $30 billion in Risperdal sales. The executive who oversaw this illegal marketing effort was Alex Gorsky, who then was promoted to chief executive of J&J. If you’re a pharmaceutical company, crime sometimes pays.

Read Drugs, Greed and a Dead Boy and When Crime Pays: J&J’s Drug Risperdal, on NYtimes, by Nicholas D. Kristof.

See study National Trends in the Office-Based Treatment of Children, Adolescents, and Adults With Antipsychotics, Arch Gen Psychiatry. 2012;69(12):1247-1256. doi:10.1001/archgenpsychiatry.2012.647, JAMA Dec 2012.

See Embracing 21st Century Information Sharing: Defining a New Paradigm for the FDA and Communications with Health Care Professionals, Food and Drug Law Journal, 2015.

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