Abstract: It is commonly thought that the FDA regulates the use
of all drugs in the United States. In fact, most hospital patients are
given drugs which are not FDA approved for the prescribed use. Once a drug
has been approved for some use, the FDA has almost no control over how
that drug is prescribed. Since old drugs with new uses are a substitute
for new drugs, the practice of off-label prescribing is a regulatory anomaly.
If there are good reasons for the FDA to have strong pre-approval powers
shouldnt FDA post-approval powers be commensurate? Alternatively, if there
are good reasons for widespread off-label prescribing doesnt this call
into question the FDAs pre-approval powers? The unregulated off-label
market gives us some idea of what the pharmaceutical market would look
like absent the FDAs requirement to test drugs for efficacy. The net benefits
of the unregulated off-label market appear to be large thus suggesting
that the pre-approval market for pharmaceuticals is over regulated.
|A paper based on this work has now been published as:|
|Alexander Tabarrok is Senior Fellow at the Independent Institute, Assistant Editor of The Independent Review, and Associate Professor of Economics at George Mason University. He received his Ph.D. in economics from George Mason University, and he has taught at the University of Virginia and Ball State University. Dr. Tabarrok is the editor of the Independent Institute books, Entrepreneurial Economics (Oxford University Press), The Voluntary City, and Changing the Guard.|
The fear of litigation reduces innovation, drive physicians and manufacturers out of lawsuit-prone specialties, and increase manufacturing and consumer costs. In the courts, data from thousands of cases all over the country demonstrate that tort system awards are driven by political factors such as judicial elections, jury compositions, and the location of courts themselves.