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HarvardX: 1962USRx The FDA and Prescription Drugs: Current Controversies in Context

The FDA and Prescription Drugs: Current Controversies in Context

Course Overview

Prescription drugs are among the most common health care interventions and have turned some once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients in the US struggle with increasing costs and express concerns about why many conditions, such as Alzheimer’s disease, remain without adequate therapeutic options.

At the center of these debates lies the US Food and Drug Administration (FDA), a federal agency responsible for monitoring the prescription drug marketplace and enforcing basic rules and laws that affect how prescription drugs are discovered, developed, and sold.

This course investigates the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will learn the rules and regulations governing the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.

What you'll learn

Topics
  • Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
  • The FDA — its history, public health role, and rules affecting US prescription drugs
  • The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
  • The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs
  • Safety evaluation of prescription drugs using “real world” data
  • Current topics stirring debate over the scope of FDA regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” laws that allow patients to obtain drugs prior to FDA approval
  • Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients
  • Module 1: Overview and History of the FDA
  • Module 2: Drug Development and Approval
  • Module 3: Drug Pricing
  • Module 4: Promotion of Drugs to Physicians, Patients, and Others
  • Module 5: Post-Approval Monitoring and Evaluation
  • Module 6: Special Classes of Drugs and Disease

Grading & Certification

This course has three types of assignments: post-video knowledge checks, engagements, and end-of-module quizzes. 

  • Knowledge checks, 40% of final grade: Post-video questions that will help make sure you understand the main points of each video.
  • Engagements, 20% of final grade: Activities that will give you an opportunity to apply concepts from each lesson to real-world questions, and to work with your peers to better understand the material. Some of the activities in the engagements will directly contribute to your overall grade on this assignment type. Discussion forum posts will not be counted in your grade, but are a great way to interact with your peers to better understand the material.
  • End-of-module quizzes, 40% of final grade: Case-based assessments that give you an opportunity to apply your knowledge to new situations. Note that access to the end-of-module quizzes is restricted to learners who have upgraded to the verified certificate track in the course.

You will be able to see the answers to all questions after you have used up your attempts, or when you get the answer correct.

Passing the course, and certification

The passing grade for this course is 70% (using the weights above).

If you register for a Verified Certificate, and your score is 70% or above, you will receive a certificate in electronic form. They are not mailed to you. Instead, you can generate them on your Progress page.

Guidelines For Collaboration

We encourage class participants to collaborate on assignments! But be sure you learn how to do the assignments yourself, and please do not post answers to discussion forums. Staff will proactively remove answers that are posted to the discussion forums.

  • It is OK to discuss or work jointly to develop a general approach to a question or assignment.
  • It is OK to get a hint from peers or course staff if you get stuck on a question or assignment.
  • You should work out the details of assignments yourself.
  • It is not OK to copy someone else's answer.
  • It is not OK to post answers to a question.

Discussion Forums

We encourage you to use the course Discussion Forum! It has many uses, and we'll prompt you to participate throughout the course.

Some good uses of the discussion forum:

  • Asking questions about course content and assignments.
  • Collaborating appropriately on assignments.
  • Contacting course staff.
  • Starting discussions related to course content.
  • Commenting on course content, including giving the instructors feedback, disagreeing with us, or suggesting improvements.

Our discussion forum guidelines

  • Be polite and encouraging.
  • Work together and work independently.
  • Post hints rather than answers. If you're not sure where to draw the line, follow the collaboration guidelines.
  • You can and should discuss questions, consider possibilities, and ask for hints.
  • You should not request or give out answers, even answers that you know are wrong.
  • Use your vote. If you agree with what someone says, don't write a post. Just click the plus button!
  • Tag your posts. If there is an issue that absolutely needs staff attention, put the word [STAFF] in brackets in your subject line. Course staff will be in the forums every day, but it may take a couple of days to get a response sometimes, especially around holidays.

Honor code statement

HarvardX requires individuals who enroll in its courses on edX to abide by the terms of the edX honor code. HarvardX will take appropriate corrective action in response to violations of the edX honor code, which may include dismissal from the HarvardX course; revocation of any certificates received for the HarvardX course; or other remedies as circumstances warrant. No refunds will be issued in the case of corrective action for such violations. Enrollees who are taking HarvardX courses as part of another program will also be governed by the academic policies of those programs.

Nondiscrimination/anti-harassment statement

Harvard University and HarvardX are committed to maintaining a safe and healthy educational and work environment in which no member of the community is excluded from participation in, denied the benefits of, or subjected to discrimination or harassment in our program. All members of the HarvardX community are expected to abide by Harvard policies on nondiscrimination, including sexual harassment, and the edX Terms of Service. If you have any questions or concerns, please contact harvardx@harvard.edu and/or report your experience through the edX contact form.

Research Statement

HarvardX pursues the science of learning. By registering as an online learner in an HX course, you will also participate in research about learning. Read our research statement to learn more.