 July 9, 2008
| Topic: |
Ethical Drugs |
| Presenter: |
Steven R. Smith, J. D., Dean and Professor of Law, California Western School of Law |
| Location: |
SDSU Foundation: Sky Park |
| Discussion: |
The prescription drug (and medical devices) system in the United States is undergoing a dramatic change. These changes are reflected in direct to consumer advertising, post-approval testing, "off label" uses, price controls and Medicare Part D, patents, and liability rules. The discussion will center on these changes and the ethical implications for research and the marketing of pharmaceuticals. |
| Readings: |
- "The FDA, Preemption, and the Supreme Court". Leonard H. Glantz, J. D., and George J. Annas, J. D., MPH. N. Eng J Med, Volume 358:1883-1885, May 1, 2008, Number 18.
- "Regulating Off-Label Drug Use Rethinking the Role of the FDA". Randall S. Stafford, M.D., Ph.D.” N. Eng J Med, Volume 358:1427-1429, April 3, 2008, Number 14.
- "New Risk From Off-Label Promotional Activity". Kenyana M. Scott and Catharine L. Du Bois. New York Law Journal, Volume 238, December 17, 2008.
For those who are interested, other articles are available upon request. Contact Diane Ballard, dballard@ucsd.edu.
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