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Killer Disease on Campus

Classroom Activity

Objective
To learn about the Food and Drug Administration's processes for new drug development.

• copy of the "Evaluating Drug Development" student handout ( HTML)
• copy of the "Development Steps" student handout ( HTML)
• copy of the "Simplified New Drug Development Process" student handout ( HTML)
• copy of the FDA's "New Drug Development Process" chart, found on the CDER (Center for Drug Evaluation and Research) Web site under the category "New Drug Development and Review," www.fda.gov/cder/handbook/
• markers
• large, poster-size paper

• copy of the Accelerated Development/Review description, found on the CDER Web site New Drug Development Process Chart (see above), www.fda.gov/cder/handbook/
• copy of the "Case Studies" student handout ( HTML)

Part I

1. Ask students why they think the government regulates the availability of new drugs.

2. Organize students into groups and provide each group with copies of the "Evaluating Drug Development" and "Development Steps" student handouts.

3. Have students read the definitions provided on the "Development Steps" student handout. Students should discuss with their group members the order they think the steps should follow. Once the order is agreed upon, have students draw a flowchart of the steps. Tell students they can cut out the steps and physically rearrange them if that will help them determine the sequence.

4. When all groups are done, have them share their results with the class. Have the class come to a consensus for the order of the steps.

5. Pass out copies of the "Simplified New Drug Development Process" student handout. Have students compare their final class chart to the simplified chart. Once they are done, hand out and discuss the actual FDA New Drug Development Process chart. Point out to students that the actual process doesn't happen sequentially, but that some steps overlap others. Also, the actual process involves additional application processes, review boards, and advisory committee overview.

6. Discuss the advantages and disadvantages to stringent, long-term studies of new drugs.

Part II

1. In Part I of the activity, students learned about the steps involved in the FDA's standard new drug development process. In this part of the lesson, they will study the accelerated process, which is used to speed the development and production of a promising new drug for serious or life-threatening illnesses.

2. First have students get acquainted with the accelerated process. Organize students into groups. Provide each group with a copy of the "Accelerated Development/Review" description found online in the FDA New Drug Development Process chart.

3. As a class, clarify and discuss the criteria used to determine whether a drug should be developed following the accelerated development/review process. Under what conditions might it be more important to use the accelerated process? According to the FDA description, the two circumstances that accelerated development can be used are (1) "a laboratory finding or physical sign that may not be a direct measurement of how a patient feels, functions, or survives, but is still considered likely to predict therapeutic benefit for the patient," and (2) "when the FDA determines that safe use of a product depends on restricting its distribution or use."

4. Tell the groups that they are teams of scientists whose job it is to review scenarios and decide whether to use the new drug development process or the accelerated development/review process. Assign each group one of the two case studies. Provide groups with copies of the "Case Studies" student handout.

5. Have groups come up with arguments for which process they would use and answer the questions provided on their student handout.

6. Conduct a class debate as to why a group chose one process over another.

Activity 1—New Drug Development Process
The FDA estimates that a drug is studied and tested for about eight-and-a-half years before it can be approved for the general public. The steps in the flowchart should be arranged in the following order:

B: Synthesis and Purification
E: Short-term Animal Testing
H: Long-term Animal Testing
A: Phase One Clinical Studies
F: Phase Two Clinical Studies
I: Phase Three Clinical Studies
D: New Drug Application
G: Review Process
C: Legally Marketed in United States

Activity 2—Case Studies
There are no right or wrong answers for this activity. The accelerated process is often used to treat serious or life-threatening illnesses in cases where the new drug is significantly better than current treatments, its use produces a therapeutic benefit for the patient, and its distribution is limited.

Web Sites

Campus Meningitis Preventable for $65
www.acha.org/projects_programs/men.cfm
Presents the American College Health Association recommendation for vaccination for college students.

Center for Disease Control: Meningococcal Disease
www.cdc.gov/ncidod/dbmd/diseaseinfo/meningococcal_g.htm
Provides information about meningococcal disease, its symptoms, and available vaccines.

Inhalational Anthrax (Post-Exposure)—Developing Antimicrobial Drugs
www.fda.gov/cder/guidance/4848dft.htm
Provides guidelines for industry on developing drugs to treat inhalational anthrax.

Melanoma Treatment
www.melanomacenter.com/whatis/melanoma_treatment.html
Discusses the symptoms and treatment for melanoma.

Meningococcal Infections
www.nfid.org/library/meningococcal/
Explains the nature of meningococcal disease and how it can be prevented.

Understanding Vaccine Safety: Immunization Remains Our Best Defense Against Deadly Disease
www.fda.gov/fdac/features/2001/401_vacc.html
Discusses the importance of vaccination.

Vaccine Product Approval Process
www.fda.gov/cber/vaccine/vacappr.htm
Outlines the process of FDA approval of a vaccine.

What Is a Clinical Trial?
clinicaltrials.gov/ct/gui/c/w1r/info/whatis?JServSessionIdzone_ct=ey64mc0wo1
Describes what a clinical trial is, how it works, and what is expected of participants.

World Health Organization: Meningitis
www.who.int/health-topics/meningitis.htm
Provides a global picture of meningitis.

The "Killer Disease on Campus" activity aligns with the following National Science Education Standards:

Grades 5-8

	Science Standard C: Life Science

Structure and function in living systems

• Disease is a breakdown in structures or functions of an organism. Some diseases are the result of intrinsic failures of the system. Others are the result of damage by infection by other organisms.

Grades 9-12

	Science Standard F: Science in Personal and Social Perspectives

Personal and community health

• The severity of disease symptoms is dependent on many factors, such as human resistance and the virulence of the disease-producing organism. Many diseases can be prevented, controlled, or cured. Some diseases, such as cancer, result from specific body dysfunctions and cannot be transmitted.