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California State University, Dominguez Hills
University of Wisconsin, Parkside
Created: December 6, 2004
Latest Update: December 6, 2004

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Index of Topics on Site FDA Regulation in a Corporate-Based Administration
One of the concerns most Americans have come to recognize as new on the list of things that must be dealt with is the lack of agency control over the safety of the foods we eat and the drugs we take. For generations we have had trust in our government that it would not permit profit to override the safety of its citizens. If a drug or food was dangerous we trusted that it would be removed from the market.

Now there are real issues that lead us to wonder if we have misplaced that trust and that remind us that governance discourse means paying attention, not to trusting to a "representative" to always have our best interest at heart. This isn't new. As the nation industrialized, the government often favored nascent industry over the individual citizen, (refernce: Ryan Railroad case) and we had ultimately to resort to the Commerce Clause to put a stop to dangerous child labor. But we often consider that in the past, with little meaning in today's civilized corporate world.

Read and consider the New York Times article on the Federal Drug Administration and its pharmaceuticals ties: Regulation Redefined: At F.D.A., Strong Drug Ties and Less Monitoring by Gardiner Harris, New York Times, December 6, 2004. At p.A1. Backup.

Discussion Questions:

  1. Agencies: Describe what the Times is calling the redefinition of regulation. Does this redefinition fit with your idea of what the FDA should be doing? Why or Why not?

  2. Law: What role did AIDS play in changing the orientation of the FDA? Consider that once a law is written, it can be applied to other cases that do not conflict with the original policy of the law. Could you make an argument that dealing with fatal illness for which new drugs are being constantly tested is different from dealing with copy cat drugs where other pharmaceuticals want a piece of the market?

  3. Women and Poverty: How has testing for the safety of drugs been different for women? Think of standardized testing practice in a male-oriented profession. Now think about drugs and their dangers at Martin Luther King Hospital. How do you think the following factors might affect healt care delivery in a hospital situated as MLK is?

    1. What about training programs for the use and dangers of newly appearing drugs?
    2. What about the left over supply of almost as good drugs? Think they'd be cheaper now?
    3. What about adequate staff trained to be alert to the symptoms indicating problems with the drugs?
    4. What about all hospitals being more dangerous over the weekend?
    5. What about hiring people who have never before hd lives depend on their discipline and attention to detail? Does that suggest a different kind of training program? Like maybe you start with an A because we expect and demand competent work. Then we help you get your work to that level of competence with supervision designed to catch mistakes and help you recognize them?

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