Expertise DescriptionI have more than 40 years in the Pharmaceutical industry with expertise on health policy, technology transfer, medico-legal, and health economics issues. I have more than 25 years experience as a former official for the Food and Drug Administration (FDA). I have managed multiple drug regulatory activities and large staffs and have extensive experience in outreach to government agencies and organized medicine. I have additional experience with private practice of family medicine and geriatrics. I have prior deposition and testimony experience, and over 10 years as an expert witness.
Areas of Expertise
My consulting experience includes working with issues related to development and marketing of pharmaceuticals, generic drug eligibility and approval, Rx/OTC Switch and patent term restoration, reimbursement, HIPAA, Healthy People 2010, GCPs, clinical trials, and medical ethics.
My professional experience includes having practiced and taught medicine, serving as medical director for a chain of long term care facilities; and being the first president of a company providing physician services in hospital emergency departments. I have won orphan drug designation and an NCI grant for a company where I was senior vice president for clinical and regulatory affairs. I planned the developing and licensing strategies for another company where I was a board member and clinical research consultant.
Last year, I prepared an expert report for an unemployment compensation carrier regarding alleged excessive drug product charges. My understanding is that the case was settled on terms favorable to insurer shortly afterwards. For 25+ years, I was a senior member of a government agency, and was in charge of regulating prescription drug promotion, and the Medicine Staff. I am a frequent consultant on issues related to drug marketing and development.
I have considerable expertise in the interpretation of clinical trial results and in FDA’s evaluation of drugs, biologics, and medical devices
I have experience as the Chairman of an organization that sets the standards for training and certifying competency in health care law. I have some knowledge of off-label drug prescribing for pain and other indications.
My 25+ years as a senior manager at the FDA included 16+ years in the Center for Drug Evaluation and Research. During the first 8 years, I oversaw regulating prescription drug promotion. During the second 8 years, following a promotion, I was in charge of regulating all OTC drugs, biopharmaceutics and generic drugs as well as prescription drug promotion. During the final 9 years, I was a top-level director. I am a recent Past President of a medical specialty society for physicians who design and carry out the clinical trials that form the basis of new drug applications.
|M.D.||John Hopkins University||Baltimore|
|J.D.||University of Maryland||Baltimore|
|M.S.||Math||Michigan State University||East Lansing||MI|
|B.A.||Math||Michigan State University||East Lansing||MI|
Medicine: Maryland, District of Columbia, California
Law: Maryland, District of Columbia, U.S. Supreme Court
Awards & Affiliation
Drug Information Association
American College of Legal Medicine
Academy of Physicians in Clinical Research
American Medical Association
American Public Health Association
Drug Information Association