MPTX 511: Introduction to Medical Product Regulation

Introduction to Medical Product Regulation
Instructors: Frances Richmond, PhD School of Pharmacy USC
Marsha Kaplon, Alfred E Mann Institute and School of Pharmacy
Numerous speakers TBA
Course weight: 3 credits

Placement: Spring 2003 Orange County campus
Summer 2003 HSC
Fall 2003 HSC

Prerequisites:

Undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience

Introduction and Purposes:

This introductory course is designed as a first course for students enrolled in the MS (Regulatory Science). It is also an optional course that serves as an overview for students from other disciplines, such as the proposed MS and Certification programs in Clinical Research, graduate programs in biomedical, pharmaceutical and engineering fields and the Pharm. D program in the School of Pharmacy. The course is designed to introduce the laws, regulations and institutions governing medical products in North America. Students will be introduced to the purposes of regulations and their relationships with the law. Particular attention will be paid to regulations that shape the developmental path of medical products. The students should be able to map the history of regulatory policies in the US. They should be able to differentiate the spheres of authority, organization and operation of FDA, FTC, OSHA, EPA and state regulatory authorities. Students will also become familiar with the regulations shaping the structure and conduct of preclinical and clinical trials.

The course will be taught through case studies and lectures. An emphasis will be placed on relatively informal lecture formats in which students are encouraged to ask and answer questions throughout the didactic session. As part of a novel strategy to meet the needs of part-time as well as full-time students, the course will be taught in a condensed period of full days in the summer term; lecture-discussions will occupy a total of approximately 40 face-to-face hours.

Course Objectives:
Below are listed some of the capabilities and knowledge expected of students who graduate from this course. Students should be able to:

- Explain the evolution of drug and device regulations as a result of key medical tragedies or policy-making events
- Draw an organizational chart for the FDA showing the roles played by different centers
- Identify the relative roles of field offices of the FDA compared to central offices in Washington
- Explain the relative roles played by FDA and FTC with regard to medical product advertising
- Draw a flow chart to explain the drug development process
- Be able to identify if a drug or device would qualify for orphan product status and why that would be advantageous
- Describe the differences in the application process for the approval to market a generic vs an innovative drug product
- Sketch a drug product insert
- Differentiate between a drug and dietary supplement, and identify which claims are and are not justifiable for a dietary supplement from a provided list
- Classify devices according to risk and identify the testing that a product in each class might be expected to undergo
- Explain what is meant by good laboratory practices and good clinical practices
- Suggest the membership for an IRB and explain to a new member what the IRB is expected to do
- Describe why audits are done and what should be expected during an audit
- Differentiate between strict liability, negligence and breach of contract
- Explain why and how the EPA and OSHA have regulatory oversight in a manufacturing workplace

Sample Class topics:

1. History of regulation in US biomedical sector; current organization of regulatory bodies
- Federal Food Drug and Cosmetic Act; Kefauver-Harris Amendments
- Medical Device Amendments, Safe Medical Device Act
- Orphan Drug Act
- Food and Drug Administration Modernization Act
- Administrative Procedures Act and proposed rulemaking
- Roles of legislative and judicial bodies
- FDA Organization

2. Regulation of new drugs
- The drug development path
- FDA drug submission procedures; INDs and NDAs
- European approaches
- Drug compliance
- Generic vs patented drugs
- OTC vs prescription drugs

Computer lab

3. Regulation of new devices and diagnostics
- The device development path
- Device classification
- 510Ks and PMAs
- Investigational Device Exemptions
- Registration and listing of manufacturers

4. Regulation of foods, dietary supplements and cosmetics
- Defining boundaries between products
- DSHEA
- Rules governing labeling and claims

5. Claims and advertising in biomedical industries
- Package inserts
- Rules governing product advertising
- Internet advertising
- Promotion vs education
- Anti-kickback statutes
- Role of the FDA and FTC

6. Rules governing preclinical testing and trials in animals
- Good Laboratory Practices
- Protocol development
- Proving safety and biocompatibility in models, dishes and animal systems
- Animal husbandry and ethics

7. Clinical trials for drugs and devices
- Good clinical Practices
- Identifying subjects, informed consent
- Investigational Review Boards
- The sponsor, investigator and patient triangle

8. Organization and operation of regulated industries to ensure regulatory compliance
- FDA inspection and enforcement options
- Adulteration and misbranding
- Prohibited acts
- Audits
- Recalls
- Horror stories

9. Legal Liability
- Breach of contract, negligence, strict liability
- Risk assessment

10. Regulatory activities of OSHA, Drug Enforcement Agency
- Defining safe working conditions
- Rules for traveling workers and home offices
- Controlled substances as marketed products
- Use of controlled products in the home and workplace

11. Rules and activities of the EPA
- Title 40, CFR
- Pollution problems in medical product industries
- Anticipating pollution by end users
- Case study- ethylene oxide sterilization

Course Requirements and Grades:

Midterm test 30%
Final examination 40%
Research paper 30%

At the end of the course students should be able to demonstrate a competent knowledge of the subject matter by formal examination. Students will work in groups to make a class presentation on a case-study topic selected in consultation with the course instructors. This presentation will be accompanied by a written paper of no more than 6 double spaced pages. The presentation and paper will be evaluated on the basis of the following criteria:
• Clear introduction to the issues or problem raised by the case study
• Review of current guidelines and identification of regulatory requirements
• Identification of other issues including policy issues
• Appropriateness of suggested approaches to problems identified from the case study
• Well-structured presentation and current bibliography in annotated format
The presentation is worth a total of 20% 0f the final grade. Of this total, 10% is based on the presentation and 10% on the written paper.

Course Textbook:
Pina, K.R Pines, W.L. (2002) A Practical Guide to food and drug law regulation (FDLI)
Reader, containing handouts, selected journal articles and news clippings

Attendance and Conduct:
The Student Handbook, SCampus and University Catalogue provide guidance regarding academic policies and procedures. Students should regard the program as a part of their professional development in which courtesy and responsibility are significant factors in success. Thus, students are expected to communicate absences from class and are expected to attend all examinations and class presentations. Under normal circumstances, papers and exams must be submitted on or before the scheduled deadlines. Failure to make appropriate arrangements in case of justifiable delay will result in a penalty of 10% in the assigned mark for the first two weeks of delay, and further penalties for additional unapproved delays.

Textbook References and Additional Readings:
N.B. Reference texts and links are not updated regularly.