This is a 3-credit course.
Designed to provide students an overview of drug discovery, development, approval, marketing, regulation, and use in the United States. This course is designed to show how all the pieces of the “U.S. medication system” fit together. This high-level overview will focus on before a drug is marketed and will provide participants with a basic understanding of topics ranging from drug discovery to development.
This course will provide participants with a basic understanding of topics ranging from drug discovery to disposal. “Foundations I” will focus on before a drug is marketed. In addition to recorded video lectures and online weekly class meetings, this course will include mandatory readings from a variety of sources and perspectives. It will provide a balanced view of
controversial topics and invites discussion using the presented content, supplemental information posted to the Discussion Boards, and students’ and faculty experiences.
Upon completion of this course, the student will:
- State the role of academia, government, industry, and serendipity in drug discovery.
- Identify the effects that the Bayh-Dole Act has had on drug discovery.
- List barriers to drug development
- Explain the cost of drug discovery and development.
- List the phases of the Food and Drug Administration’s drug approval process and identify the key characteristics of each phase.
- Compare and contrast the approval processes for drugs, biologicals, generics, biosimilars, and dietary supplements.
- Explain the creation of a drug label and its various components.
- Identify the various types of “drug products” on the US market and regulations that affect their use.
- State the sources of raw pharmaceutical materials, who manufactures pharmaceutical products, and the role of FDA oversight in this process.
- Debate current controversies in the discovery, development, and regulation of drugs.
|Course Overview||Course Introduction; Writing a Final Paper|
|Module 1: Drug Discovery and Development||Drug Discovery and Development; Industry, academia, and the government’s roles in drug discovery and development; Serendipity and drug discovery; The Bayh-Dole Act; Barrier in the drug discovery and approval process & incentives; The cost of drug discovery, development and approval|
|Module 2: FDA Approval Process||Pre-clinical testing; Phases of Drug Approval; Investigational Review Boards (IRBs); Expanded Access & Right to try; Types of drugs – excluding unapproved drugs; “Abbreviated” New Drug Approvals; “Faster” approvals|
|Module 3: Pharmaceutical Manufacturing||Manufacturers; Source of raw materials; Making finished drug products; FDA oversight of drug production; Stability and expiration dating|
|Module 4: Marketed Products and Other “Drugs”||Generic and brand drug names; Labeling; Nonprescription drugs; Dietary supplements; Vitamins & minerals; Homeopathic remedies; Medical foods; Devices including those that “look like drugs”; Unapproved drugs; Controlled substances: scheduling, drugs of abuse, and the DEA|
There are no existing prerequisites for this course.
There is no required textbook for this course; however, students are required to subscribe to STAT+, which is a pharma/health care news and analysis Website. To subscribe, go to www.statnews.com/subscribe. At the payment page, use code ACADEMIC75 to receive a 75% student discount on the subscription rate. Reading assignments from online textbooks, journal articles, lay media articles (New York Times and Wall Street Journal), and websites will be assigned for each module (see Appendix B). UF students have access to the New York Times and Wall Street Journal at no cost (https://news.hr.ufl.edu/technology/did-you-know-uf-offers-free-online-subscriptions-to-the-new-york-times-wall-street-journal/). In this manner, students will have access to the latest in the ever-changing landscape of information.