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HarvardX: Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

4.8 stars
51 ratings

Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing.

8 weeks
2–5 hours per week
Self-paced
Progress at your own speed
Free
Optional upgrade available

There is one session available:

117,581 already enrolled! After a course session ends, it will be archivedOpens in a new tab.
Starts Dec 3

About this course

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Prescription drugs are among the most common health care interventions and have turnedsome 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 whymany 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 willlearn the rules and regulationsgoverning the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.

At a glance

  • Language: English
  • Video Transcripts: اَلْعَرَبِيَّةُ, Deutsch, English, Español, Français, हिन्दी, Bahasa Indonesia, Português, Kiswahili, తెలుగు, Türkçe, 中文
  • Associated skills:Safety Monitoring, Medical Prescription, Marketing, Drug Development, Drug Administration, Medical Education, Pharmaceuticals

What you'll learn

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  • 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 prescription drugs in the US
  • 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” lawsthat 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 in the United States
  • Module 4: Marketing strategies
  • Module 5: Post-approval evaluation
  • Module 6: Emerging medical technologies

Frequently Asked Questions

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How is the honor code upheld?
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.

How does my participation contribute to research?
By registering as an online learner in our open online courses, you are also participating in research intended to enhance HarvardX's instructional offerings as well as the quality of learning and related sciences worldwide. In the interest of research, you may be exposed to some variations in the course materials. HarvardX does not use learner data for any purpose beyond the University's stated missions of education and research. For purposes of research, we may share information we collect from online learning activities, including Personally Identifiable Information, with researchers beyond Harvard. However, your Personally Identifiable Information will only be shared as permitted by applicable law, will be limited to what is necessary to perform the research, and will be subject to an agreement to protect the data. We may also share with the public or third parties aggregated information that does not personally identify you. Similarly, any research findings will be reported at the aggregate level and will not expose your personal identity.

Please read the edX Privacy Policy for more information regarding the processing, transmission, and use of data collected through the edX platform.

How are non-discrimination and anti-harassment supported?
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.

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