In this interdisciplinary course, we review the history, authorizing statute and regulatory authority of US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy) and the influence and impact of FDA on science, health policy and public health.

US Food and Drug Administration, Drug Development, Public Health and Health Policy
PB HLTH 236 CN76069 (2 unit)
Room: 106 Stanley Hall
Thursdays (6:30-8:30)
Maximum enrollment: 120 

Course Description:

In this interdisciplinary course, we review the history, authorizing statute and regulatory authority of US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy) and the influence and impact of FDA on science, health policy and public health. We present the principles and process of drug development and illustrate the evolution of regulatory policies through the Forum for Collaborative HIV Research’s experience in HIV/AIDS, HCV, CMV and liver diseases. We demonstrate the interdisciplinary nature of the agency’s mandate (basic sciences, statistics, toxicology, pharmacology, clinical medicine, ethics, policy, law, political science, economic, foreign policy) and its responsiveness to public health needs. Real-time examples such as maintaining quality of generic drug products distributed through PEPFAR, development of regulatory policy on the use of next-generation sequencing platforms, ethical issues in HIV cure research, qualification of biomarkers for liver fibrosis and cirrhosis, and acceptance of suppression of DNAemia for approval of new drugs and vaccines to prevent CMV disease in transplant patients serve as case studies to illustrate the benefits and contribution of a stakeholder engagement process of deliberation. Biotech and pharmaceutical industry experts will participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health community. The course will be of interest to students in public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry.

Learning Objectives:

By the end of this course, students will be expected to be able to:

1. Describe and discuss the policies underlying current drug regulation and the impact on clinical trial design and statistics, benefit-risk analysis, drug safety, medical ethics, as well as global health and foreign policy. 
2. Understand the historical progression to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), including mechanisms for accelerated approval and accelerated/expanded access.
3. Understand the role of the private sector, community and patient advocacy, and academic medicine in the evolving development of federal health policy and research.
4. Understand the process for developing a drug, the economic and financial impact, prepare a draft drug development plan and prepare for employment in the pharmaceutical or regulatory environment. 

Instructors:

Jur Strobos, MD JD, a specialist in Food and Drug Law, served as Director of Policy Research under FDA Commissioner Kessler, has held VP positions in Clinical Research and Regulatory Affairs for various pharmaceutical companies. He served as deputy director of the Forum for Collaborative HIV Research from January 2010 to December 2011, and is currently Of Counsel with Olsson Frank Weeda Terman Matz PC.

Veronica Miller, PhD, the Executive Director of the Washington-based Forum for Collaborative HIV Research, is an authority in HIV clinical research with over 20 years of experience in HIV clinical and drug development research. She has led numerous projects advancing HIV, HCV, CMV and liver fibrosis drug development in collaboration with the FDA, the European Medicines Agency, pharmaceutical and diagnostic industry, community and academia.

Course Evaluations:

 “This was a fantastic course! The topics covered were both specific enough and broad enough, and are things that I always wanted to learn but couldn't covered in any other courses. The instructors are experts in their field and are so good at sharing their unique experiences and expertise. It was very valuable to have both of them, covering different perspectives of the same general themes. They both took the time to meet with me, even though I was not a registered student, and they were very welcoming of any questions from the audience. It was also great to have so many guest speakers, each offering invaluable insights into their work. The Global Health lecture was one of my favorites; when else do you get to hear experts of that magnitude discuss an answer to your question? Their opinions are the result of years of global health experience and knowledge, and access to something like that is so limited. Overall this course absolutely exceeded my expectations. It opened my mind to so many important issues and inspired me in my work. It was so great that it was open to UC affiliates, I think so many of us appreciated this flexibility. Thank you so much Dr. Strobos and Dr. Miller, this was an amazing experience.” -Elena Foster, UC Davis Biomedical Engineering Graduate Student

“Informative, interesting and engaging taught by extraordinary instructors.” -Farrah Kashfipour, UCSF Global Health Sciences Research Fellow

“This is a great course for anyone interested in pursuing a career in life sciences! Jur and Veronica are incredibly knowledgeable and also make themselves available for questions and advice.” 

“Quite a refreshing course to learn about FDA, drug discovery and its socio-economic impacts.” -Navneet Matharu, UCSF Postdoctoral Scholar

“This is a great course that explains FDA regulations in the light of the historic incidences leading to their implementation. The AIDS crisis substantially influenced the FDA and I highly recommend this lecture for anybody who wants to learn more about team science, the HIV cure, AIDS in the 80ies and 90ies, and the AIDS Coalition to Unleash Power (ACT-UP).” -Marcel Alavi, UCSF Ophthalmology Postdoctoral Fellow

“A useful class for people of various disciplines wanting to know more about the drug development process and FDA regulations around it.” -Rutwik Shah, UC Berkeley-UCSF Translational Medicine Graduate Student

“HIV is an excellent example to study and follow.”

“A very good course for every biologist.” -Mohsin Tariq, UC Berkeley Integrative Biology Visiting Researcher

“I enjoyed so much this course, because not only I got knowledge, I got a vision further how the FDA works, and what kind of issues it faces in the pharmaceutical environment, how it take care of public health and how it make regulations to give a chance to launch to the market secure and effective medications in an easier and faster way.” -Zenaida Munive-Colin, UNAM Visiting Scholar

“Good course, good teachers!” -Haizhong Zhu, UC Berkeley Center for Chinese Studies Visiting Scholar

“Helpful to give some insight about the controversial FDA decision making process.”

“The consequential mechanisms for developing, controlling the creation of, and finally profiting from drugs intended for human betterment seems overwhelming to take in and fully understand, but this course broke much (but not all) of this subject into digestible pieces.” -William Klitz, UC Berkeley Integrative Biology Visiting Scholar

“It is very informative to know the FDA regulations on food and drug administration, and drug development and also helpful for networking.” -Nayaki Muthusamy, UCSF Postdoctoral Fellow

“Veronica and Strobos made the class very interesting and informative by giving us examples from their own experiences. They also encouraged students to ask questions and they addressed each questions with appropriate answers. I found the guest lectures very useful.” -Geetha Mohan, UCSF Postdoctoral Research Scholar

“Thank you!”