Event Title
Divorcing Profit Motivation from New Drug Research: A Consideration of Proposals to Provide the FDA With Reliable Test Data
Location
Duke Law School
Start Date
20-1-1978 1:15 PM
End Date
20-1-1978 2:30 PM
Description
Under present federal regulation, a pharmaceutical company that is attempting to gain Food and Drug Administration (FDA) approval for marketing a new drug is responsible for conducting the necessary drug experimentation. It has been forcefully argued that because the company has a financial interest in successful test results, the present drug testing system contains an inherent bias that adversely affects the accuracy and acceptability of drug research. Concern about these effects has led to proposals that pharmaceutical research be conducted by independent parties with no financial interest in the outcome of the research. To evaluate whether such regulatory changes are necessary, this Article will examine the relationship between the profit-oriented testing of drugs and the need for both ethical human experimentation and accurate experimental data. Consideration will be given to what improvements, if any, might be made in the present system.
Related Paper
Sidney A. Shapiro, Divorcing Profit Motivation from New Drug Research: A Consideration of Proposals to Provide the FDA With Reliable Test Data, 1978 Duke Law Journal 155-183 (1978)
Available at: http://scholarship.law.duke.edu/dlj/vol27/iss1/5Divorcing Profit Motivation from New Drug Research: A Consideration of Proposals to Provide the FDA With Reliable Test Data
Duke Law School
Under present federal regulation, a pharmaceutical company that is attempting to gain Food and Drug Administration (FDA) approval for marketing a new drug is responsible for conducting the necessary drug experimentation. It has been forcefully argued that because the company has a financial interest in successful test results, the present drug testing system contains an inherent bias that adversely affects the accuracy and acceptability of drug research. Concern about these effects has led to proposals that pharmaceutical research be conducted by independent parties with no financial interest in the outcome of the research. To evaluate whether such regulatory changes are necessary, this Article will examine the relationship between the profit-oriented testing of drugs and the need for both ethical human experimentation and accurate experimental data. Consideration will be given to what improvements, if any, might be made in the present system.
Comments
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