Advancing a Free Society

The FDA’s War on Drugs

Wednesday, July 27, 2011

When it comes to the key pharmaceutical issue of off-label drug use, it’s clear the federal government is confused. One arm of the government actively denounces off-label drug use, going so far as to turn the promotion of off-label use by drug companies into a crime, while other arms of the government actively promote it. The implications of the suppression of off-label promotion are scary, not just for drug company shareholders and executives, but also for patients. If you make it a crime to promote a drug that makes us healthier, the result will be less promotion—and unhealthier citizens.

On April 14, 2011 the U.S. government threatened to exclude Forest Laboratories, a pharmaceutical company, from future government business unless it removed its hapless CEO, Howard Solomon. Why? Because Forest had sold an unapproved drug and promoted two other drugs for "off-label" uses—i.e. uses for which the drugs were not approved. Forest agreed to pay the government a whopping $313 million in penalties for these violations. Still, the government wanted Solomon to step down even though it’s unclear whether he had anything to do with the actual violations. Solomon says he will challenge the "unwarranted and unprecedented" ban of Forest from future government business.

You would think that a government that institutes a $313 million penalty and tries to strong-arm a private company into removing its CEO would be clear on the principles of this case. You would be wrong.

Continue reading Charles Hooper and David Henderson…