The Prescription Project, National Physicians Alliance, Prescription Access Litigation (PAL) and US PIRG have submitted public comments opposing an FDA Draft Guidance that would allow drug companies and their salespeople to distribute reprints of medical journal articles discussing off-label uses to physicians.
The groups outline numerous reasons why the distribution of reprints by pharmaceutical representatives does not facilitate evidence-based decision making and could jeopardize patient safety and public health. They urge the FDA not to issue the Draft Guidance in its current form and to hold public hearings on industry marketing of products for off-label purposes.
Off-label prescribing, the prescribing of drugs for non-FDA approved purposes, is legal. However, the marketing of drugs by pharmaceutical companies for off-label purposes is not legal. Currently, pharmaceutical companies can provide medical journal articles discussing off-label uses to physicians only if the physician asks for the information. The FDA guidance would loosen that restriction.