Big Pharma pushes the Snake Oil approach

FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rulesShould a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules against such “off-label” marketing — racking up billions of dollars in settlements. And the Food and Drug Administration has held firm to the idea that sales pitches generally should not include information on uses not approved by the agency.But in the long-running conflict between federal regulators and drugmakers over how companies promote their drugs for unapproved uses, the landscape could be shifting, if only in subtle ways, and the outcome could affect doctors and patients alike.Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year.Critics of the curr...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs