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  • Regulating Drugs: The Creation of the FDA
  • The Progressive Era: Public Pressure and Government Actions

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    » Post-Viewing Lesson Plan:

    Regulating Drugs:
     The Creation of the FDA

    Students will learn about the history and function of the Food and Drug Administration (FDA). They will look at concerns facing society today and compare them to the problems of the Progressive Era.

    This lesson is divided into two steps. (Note: Each step can be completed independently.)

    » Materials Needed:

    Students will need Internet access, writing materials and a random selection of popular magazines.

    » Lesson Objectives:

    In this lesson students will:

    • Explore the jurisdiction of the FDA
    • Examine major issues facing the FDA today
    • Trace the development of the FDA


    Step One "Regulating Drugs and Services"

    » Procedure:

    The FDA has a complex history. Regulation of food and drugs can be traced back to colonial times. In 1948, the federal government began inspecting imported drugs. Today, the FDA is a scientific, public health and regulatory agency responsible for overseeing a large number of consumer products. To determine how much the students know about this agency, write the following questions on the board or an overhead:

    • What kinds of food and health products does the United States Food and Drug Administration regulate?
    • What products or services are excluded from regulation?
    • What products or services receive major attention from the FDA today?

    Students can brainstorm answers to these questions by examining copies of current magazines. Teachers can obtain magazine copies, up to two or three months old, from the school library. Have the students skim the magazines and take notes on articles and advertisements that illustrate:

    • Products or services regulated by the FDA
    • Products or services not regulated by the FDA
    • Products or services that receive major attention by the FDA

    Give the students five-10 minutes to examine magazines and then ask students what answers they found. List the answers on the board.

    Students should check their answers by selecting "What FDA Regulates" and "What the FDA Does Not Regulate" found on the FDA's Web site at: http://www.fda.gov/opacom/hpview.html

    Using the same Web page, have students select "Hot Topics" in the upper right corner.

    • Ask the students to name some hot topics and list these on the board.
    • Ask the students to read two articles on any of the topics listed.
    • As a large group, discuss which of these topics may have been of concern at the turn of the 20th century when the Pure Food and Drug Act and the Meat Inspection Act were passed?

    Step Two "History of the FDA"

    » Procedure:

    The article "History of the FDA," on the FDA's Web site, traces the development of the modern FDA from 1906 with the passage of the Pure Food and Drug Act. The article, written by John P. Swann from the FDA History Office, is quite comprehensive. This material would be most appropriate for 10th-12th grade health or government classes and can be found at: http://www.fda.gov/oc/history/historyoffda/default.htm

    Divide the class into six groups and assign each group one of the sections from the reading:

    1. Origins
    2. The 1906 Food and Drugs Act and Its Enforcement
    3. The 1938 Food, Drug and Cosmetic Act
    4. Drugs and Foods Under the 1938 Act and Its Amendments
    5. Regulating Cosmetics, Devices, and Veterinary Medicine After 1938
    6. Trends in the Last Quarter-Century

    Ask students to summarize, using their own words, the major events, problems, laws and individuals in the reading. Each student should read his section independently and take notes. Groups should compile a group summary using the individual notes. A group leader should be selected to present to the class.

    » Method of Evaluation:

    Collect the individual notes and group summary.

    » Extending the Lesson:

    Teachers Resources Health
    http://www.glencoe.com/sec/health/teachres/lessonplans/rsdrug.shtml
    This lesson plan may be used in health classes that are studying topics in medicines, prescriptions and over-the-counter drugs. This lesson helps students understand the process by which medications are approved for use in the United States.

    Dangerous Prescription
    http://www.pbs.org/wgbh/pages/frontline/shows/prescription
    FRONTLINE's film and Web site investigating the FDA and drug safety will air starting Nov. 13, 2003.

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