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

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8 weeks long

Brief Introduction

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

Course Summary

This course delves into the complex world of prescription drug regulation, cost, and access. It explores the current controversies and context surrounding these issues.

Key Learning Points

  • Learn about the regulatory process for prescription drugs in the US and globally
  • Examine the impact of drug pricing on access to healthcare
  • Explore innovative approaches to increasing access to prescription drugs

Related Topics for further study


Learning Outcomes

  • Understand the regulatory process for prescription drugs
  • Analyze the impact of drug pricing on access to healthcare
  • Explore innovative approaches to increasing access to prescription drugs

Prerequisites or good to have knowledge before taking this course

  • Basic understanding of healthcare systems
  • Familiarity with pharmaceutical industry

Course Difficulty Level

Intermediate

Course Format

  • Online self-paced
  • Video lectures
  • Case studies

Similar Courses

  • Global Health: An Interdisciplinary Overview
  • Healthcare Innovation and Entrepreneurship

Related Education Paths


Notable People in This Field

  • Dr. Peter Bach
  • Dr. Ezekiel Emanuel

Related Books

Description

Course description

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

In this course, we will investigate the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will understand the rules and regulations related to the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating the pharmaceutical market.

Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn AMA PRA Category 1 Credit™ (2 credits).

Knowledge

  • What you'll learn
  • 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 the US prescription drug market
  • 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 debates over the scope of FDA regulation, such as dietary supplements, different special classes of prescription drugs, and “right to try” laws relating to experimental drugs with limited testing

Outline

  • Overview and history of the FDA
  • Drug development and approval
  • Drug pricing in the United States
  • Marketing strategies
  • Post-approval evaluation
  • Emerging medical technologies

Summary of User Reviews

The Prescription Drug Regulation, Cost, and Access: Current Controversies and Context course at Harvard Online Learning has received positive reviews from many users. One key aspect that users found good was the engaging and informative lectures delivered by the professor. However, some users have noted a few cons such as the course being too basic and lacking in practical examples.

Key Aspect Users Liked About This Course

engaging and informative lectures delivered by the professor

Pros from User Reviews

  • Access to high-quality lectures from a world-renowned institution
  • Comprehensive coverage of drug regulation, cost, and access issues
  • Flexible learning options with self-paced modules
  • Opportunity to engage with other learners and industry experts

Cons from User Reviews

  • Course content may be too basic for some users
  • Lack of practical examples and case studies
  • Limited interaction with the professor
  • Some technical issues with the online platform reported by users
Free*
English
9th Sep, 2020
8th Sep, 2021
8 weeks long
Aaron Kesselheim, Jonathan Darrow, Ameet Sarpatwari
Harvard University, Harvard Medical School
Harvard University

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