HLT-203: Legal Considerations in Drug Development
Welcome to Lawshelf’s video-course on legal and ethical considerations in drug development. More than 4.7 million Americans work in the pharmaceutical industry and more than 16 million work in healthcare. This course looks at the landscape of how the drug development process is regulated and at some of those most important regulations. Drug development and marketing is, of course, the lifeblood of the pharmaceutical industry.
This is an intermediate-level course and it is recommended for people with some knowledge of rules that relate to drugs, healthcare or pharmaceuticals, but the course can be useful for people with no such background.
The course starts by laying out the process of drug testing and describing the governmental framework that regulates the industry. We also look at the details and impacts of the 21st Century Cures Act, passed in 2016.
Module 2 begins our discussion of promotion and marketing, the other major topic of our course. We’ll focus on the “Bad ad” program and the many federal regulations that seek to ensure that consumers are given only information that is useful and accurate.
Module 3 focuses on drug pricing, including abusive pricing and antitrust issues. We will look at case studies in this regard.
Our last 2 modules look at government steps to relax regulations for drugs that are urgently needed. We will look at the requirements and procedures for expediting drug approval and ways the government seeks to expand access to critical drugs.
We hope that this course will give healthcare workers an understanding of the regulatory world in which they operate and ideas of all of the things they must watch for, especially in marketing and making representations about drugs and healthcare services.
Best of luck and we welcome your feedback.