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Off-label probes are looking into physicians' role

A government crackdown on drug companies could have a chilling effect on doctors communicating about off-label drug uses, legal experts say.

By Amy Lynn Sorrel, amednews staff. Aug. 21, 2006.

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As pharmaceutical companies continue to come under fire for illegally promoting unapproved uses of their drugs, legal experts say that the government may now be shifting the spotlight onto physicians' role in manufacturers' off-label marketing.

The Federal Food, Drug and Cosmetic Act prohibits drugmakers from marketing medications for uses that are not approved by the Food and Drug Administration. Within the last three years, the Dept. of Justice has accused at least two companies of using doctors in illegal promotion tactics.

However, federal guidelines permit doctors to prescribe a drug for "off-label" uses and to independently share information with the medical community about its safety and efficacy through continuing medical education seminars, research publication or other peer-to-peer communications.

"What companies have done is scoured the landscape for doctors who are favorable to the off-label uses of a drug and then hired them to be speakers about a subject because the doctor is under no restriction in terms of the use or discussion of it," said nephrologist Jerome P. Kassirer, MD, a professor at Tufts University School of Medicine in Boston.

Drug companies are allowed to sponsor seminars where doctors are often paid to speak about a medication.

If doctors are not cautious about such arrangements, they could be inviting unexpected legal trouble and be held jointly liable with the manufacturer for illegal promotion, said Utah Assistant Attorney General David R. Stallard.