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Patient Beware: Off-label drug promotion by pharmaceutical companies
https://www.sciencebasedmedicine.org/patient-beware-off-label-drug-promotion-by-pharmaceutical-companies/"Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.
Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.
Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.
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In the meantime, patients should be aware that off-label prescribing is not unusual and that it is sometimes based on insufficient evidence, a problem that some experts think could be exacerbated by more liberal sales promotion practices. Patients have every right to ask their physicians the circumstances of his or her prescribing a drug and the evidence for doing so."
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A good read, all the way through.
