Corporate Counsel Magazine reports that Allergan, the maker of Botox, has decided to contest the FDA's ban on off-label marketing of approved pharmaceuticals.
To recap, off-label use (use to treat a condition other than the condition for which the drug or device was approved by the FDA) of approved drugs by doctors is not illegal. [Indeed, in oncology and other specialties, over 50% of all drug use is off-label.] Nor is it illegal for doctors to report on the successes they have obtained from such use, in medical journals, at conferences, and the like. But a drug company may not tell other physicians, or indeed anyone else, that its product has been successfully used off-label uses. Allergan, of Irvine, Calif., has now sued to overturn this "truth ban": the drug company's claim is that the government's legal position -- that it's a crime for a drug company to communicate truthful information to physicians about off-label uses of its products -- violates the First Amendment.
This is one of those suits that, had I been in private practice instead of academia, I would have been itching to file for years. Countless lives can be saved if knowledge of a legal and valuable activity (off-label prescribing that is having positive therapeutic effects) is made known to physicians who might not be reading the scholarly journals. I look forward to following the developments in the Allergan case.