Glaxo's $3 billion settlement and off-label prescribing

There have been number of high profile lawsuits alleging illegal marketing practices launched by the Department of Justice against pharmaceutical companies in recent years. Previous fines for illegal marketing practices (among other things) included $2.3 billion settlements from Pfizer and $1.4 billion from Eli Lilly. Now the Department of Justice and other government agencies are set to obtain $3 billion from Glaxo. I spoke to Ralph Hall, an attorney and Professor of Practice at the University of Minnesota Law School, and asked him how the case would affect the ongoing battle over industry marketing practices.

"The marketing issues" he explained, "include concerns over off-label promotion and company interactions with physicians." Under existing FDA regulations, companies are prohibited from communicating any information about potential off-label uses to physicians, even if the information has been previously published in peer-reviewed journals. Glaxo's settlement, however is unlikelty to settle the issue: "The FDA's legal basis for prohibiting truthful off-label promotion is currently being challenged in the 2nd Circuit in U.S. v Caronia. This case - a 1st Amendment challenge - may well settle the question whether truthful off-label promotion is considered protected speech."

Given the rapid advance of medical innovation, and the importance of off-label treatments for many diseases, from cancer to Lupus, a strong case can be made for allowing companies to present to physicians (who are, after all, experts) truthful evidence from peer-reviewed journals. The FDA might argue this would discourage companies form seeking additional label indications for off-label uses, but the real disincentive is the enormous time and cost associated with seeking FDA approval for new indications, which can cost billions and take over a decade. Some compromise would seem to be in order - perhaps with a qualification that the evidence hasn't been reviewed by the FDA, and may be disproved by additional research. Still, physicians already know this - and should be trusted to make their own educated decisions with all the evidence available to them.

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