Monday, August 11, 2003

"Promotion" of off-label drug use?

Good story from the Associated Press on a whistleblower suit in Boston that accuses Parke-Davis and its parent, Warner Lambert (all part of Pfizer now) of various nefarious and underhanded activities to encourage physicians to prescribe Neurontin "for unapproved uses such as relieving pain, headaches, and psychiatric illnesses." (Additional details about the alleged marketing abuses are described in an article in the Indianapolis Star.) Prescribing for an off-label use is perfectly legal, but manufacturers may not "promote" approved drugs for off-label uses. "Promotion," as the article makes clear, is a vague term, which allows for some leeway. Up to a point, we should welcome off-label uses, which are a cornerstone of medical progress, and who better than the manufacturer to know how the drug might be used in addition to its approved uses? But the law clearly expresses a preference for manufacturers to develop their theories about approved drugs through formal clinical trials and resubmission of data to the FDA to expand the claims for which the drug may be marketed. It will be interesting to see where the district court draws the line between innovation and patient safety.
posted by tommayo, 3:01 PM

Health care law (including public health law, medical ethics, and life sciences), with digressions into constitutional law, poetry, and other things that matter