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Regulation of Prescription Drugs & Biologics By the U.S. Food & Drug Administration

East Baltimore
Winter Inst. term
Health Policy and Management
2 credits
Academic Year:
2017 - 2018
Thu 01/11/2018 - Fri 01/12/2018
Class Times:
  • Th F,  9:00am - 5:30pm
Auditors Allowed:
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor :
Pamela Davis
Frequency Schedule:
One Year Only

How does a start-up biotech company deal with FDA? Should seriously ill patients have access to unapproved drugs or biologics that might extend their lives? Why are there delays in FDA approval of some generic drugs? How does FDA go about deciding whether Americans should have access to a new drug—or not?

Reviews FDA’s regulation of prescription drugs and biologics. Discusses the relevant parts of the Food Drug & Cosmetic Act and FDA’s regulations. Includes the development of drugs and biologics from preclinical studies to investigational new drug status to post-approval (‘Phase IV’) studies. Discusses generic drugs, orphan drugs, and biosimilars. Examines ‘market exclusivity.’ Explores the public debate on ‘compassionate use’ of unapproved drugs and biologics. Introduces whether FDA should continue to withhold from public disclosure clinical data submitted to support the approval of drugs and biologics.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Explain the stages of FDA’s approval and post-approval processes for drugs and biologics
  2. Critique FDA’s approach to generic drugs, orphan drugs, and biosimilars
  3. Identify the triggers for granting market exclusivity to a drug or biologic
  4. Link public health concerns with FDA’s ‘compassionate use’ policies
  5. Analyze FDA’s withholding of clinical trial data
Methods of Assessment:

Online Critique of Course Readings (20% weight);In-Class Workshop (30% weight);In-Class Reflection (15% weight); Case Study (35% weight)

Enrollment Restriction:

Students who completed the special studies version of this course (302.841.51) should not take this course.

Instructor Consent:

No consent required

Special Comments:

Students are expected to participate in class discussions, presentations, and complete all assigned readings prior to the course. The final written policy analysis assignment will be due no later than February 2, 2018.