文档介绍：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