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Archive for January, 2010

As noted on the syllabus, please read this article for class tomorrow concerning food production and regulation in the United States.  We’ll discuss it in class, then continue the discussion here.

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Online Readings for Tuesday

As noted on the syllabus, please read the following articles for our discussion on Tuesday:

  1. N.Y. Times:  Advisers Say FDA’s Flaws Put Lives at Risk
  2. Washington Post:  FDA Told U.S. Drug System Is Broken
  3. CNN:  FDA Scientists Allege Mismanagement at Agency
  4. Optional:  FDA Science and Mission at Risk

Let’s start the discussion in class, and continue here if necessary.

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Welcome to the Food & Drug Law course at SMU Law School.  I will use this blog to post news articles related to the material we discuss in class. You can post responses for class participation credit:  just make sure to list your first name and at least your last initial (e.g., “Margaret H.”).  I will also use this blog to update your reading assignments and post other relevant information about the course this semester, so please review the blog before class.

As you can see from the picture, FDA recently celebrated its centennial anniversary, and it continues to be an important and fascinating agency.  This course examines how the FDA regulates food, drugs, medical devices, and biotechnology.  The FDA is the oldest consumer protection agency in the United States, and it regulates a significant portion of the U.S. economy.  This course will address the history and scope of the FDA’s authority, and how the agency has evolved to deal with modern developments in the biosciences, as well as emerging public health and safety issues, such as bioterrorism and advances in genetic research. Students will learn theories and study examples of risk regulation, statutory interpretation, inter-agency cooperation, public participation, and agency policymaking.  We will also focus on the FDA’s relationships with Congress, the executive branch, and perhaps most importantly, the industries it regulates.

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