
Peter Pitts
FDA Consultant
About
Peter Pitts is a Visiting Professor at the University of Paris Medical School and President of the Center for Medicine in the Public Interest. He is a former member of the United States Senior Executive Service and Associate Commissioner of the US Food & Drug Administration. Pitts is a member of the Council for International Organizations of Medical Sciences (CIOMS) Expert Working Group to help advance patient involvement in the development and safe use of medicines. (CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.) He is the lead author of many professional peer reviewed publications including the Lancet, Therapeutic Innovation and Regulatory Science, and Nature Biotechnology. He is an Associate Editor of Therapeutic Innovation & Regulatory Science (the official DIA journal), a member of the External Advisory Board, IMS Institute for Healthcare Informatics in Asia, Executive Advisory Board, the Galien Foundation, Editorial Advisory Board, Food and Drug Policy Forum, Advisory Board, Journal of Commercial Biotechnology and a member of the Editorial Advisory Board of The Patient Magazine. Pitts lives in New York City.
Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, real world evidence, social media, off label-communications, pharmacovigilance, patient-focused drug development, abuse-deterrent opioids, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling.
His comments and commentaries on health care policy issues regularly appear in The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, Time, Newsweek, The Boston Globe, The Washington Times, The Chicago Tribune, The San Francisco Examiner, Investor’s Business Daily, The Baltimore Sun, The Economist, The Lancet, Nature Biotechnology, BioCentury, The Journal of Commercial Biotechnology, the BBC World Service, Fox News, CNBC, Bloomberg, The PBS NewsHour, NBC Dateline, Sky News, La Stampa. L’Opinion, The Daily Show with John Stewart, among others.
His new book is The Value Equation: A. Journey Through the Innovation Ecosystem in the Time of COVID. He is also the author of Common-Sense Healthcare for Common Sense Americans and Become Strategic or Die, widely recognized as a cutting- edge study of how leadership, in order to be successful over the long term, must be combined with strategic vision and ethical practice. He is the editor of Coincidence or Crisis, a discussion of global prescription medicine counterfeiting and Physician Disempowerment: A Transatlantic Malaise.
A graduate of McGill University, he is married to Jane Mogel, and has two sons.