WeekOffLabelUseofPrescriptionDrugs.pptVIP

Week 12: Off-Label Use of Prescription Drugs David Baumer Fall 2006 Off-Label Uses Are Not New (1) The FDA approves drugs for uses that appear on the label Off-label use can be accepted practice if there is a scientific foundation And it is not experimental Product Liability Pls. still have the burden of proof Off-Label use does not create a presumption of negligent practice Off-Label Prescribing The AMA estimates that 40% of all prescriptions are off-label Off-label prescribing allows drug manufacturers to find new markets for patented drugs without undergoing costs of an NDA Drug manufacturers are not allowed to promote off-label uses of their products On the other hand, there is substantial question as to whether disseminating scientific studies to physicians is promotion Information about Off-Label Uses of Prescription Drugs Under the FDAMA and FDA Guidance Documents A firm would not have to wait until the FDA approves a SNDA before disseminating information about off-label uses of drugs, provided: The drug has been approved by the FDA Is a reprint of a peer-reviewed scientific or medical journal article Does not pose a risk to public health Is not false or misleading Is not derived without permission from another manufacturer’s clinics Includes disclosures that the off-label use is not FDA approved A firm would have to submit a copy of the information 60 days in advance Information about Off-Label Uses of Prescription Drugs A firm that had not submitted a supplemental application could begin disseminating information if It certified that it would submit a supplemental application within 6 months Provided adequate protocol and a reasonable schedule for necessary studies, or Received an exemption from the requirement on the grounds that necessary studies would be unethical or economically prohibitive Information about Off-Label Uses of Prescription Drugs The aforementioned rules were eviscerated by a Dist. Ct. ruling in 1999 declaring parts of CDs and FDAMA u