Peter Rheinstein
Severn Health Solutions
Badges
Claimed Lawyer Profile
Practice Area
- Health Care Law
Jurisdictions Admitted to Practice
- District of Columbia
- District of Columbia Bar
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- Maryland
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- U.S. Supreme Court
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Professional Experience
- Publisher
- Discovery Medicine
- - Current
- With colleagues from Johns Hopkins Medical Institutions, started publication of a journal summarizing major advances in cutting edge research. Assembled a distinguished board of senior editors. Discovery Medicine is indexed at www.pubmed.gov as Discov Med (Details at http://www.discoverymedicine.com.)
- President
- Severn Health Solutions
- - Current
- Consultant to industry, medical publishers, investors and law firms on issues related to development and marketing of pharmaceuticals, generic drug eligibility and approval, prescription drug promotion, Rx/OTC Switch and patent term restoration, reimbursement, HIPAA, Healthy People 2010, GCPs, clinical trials, medical ethics
- Clinical Research Consultant
- Marnac, Inc.
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- Consulted on design and regulatory issues for Phase II clinical trials of pirfenidone in pulmonary fibrosis and multiple sclerosis; Edited Clinical Investigator Brochures. Elected to Marnac Board of Directors 08/03; Helped license pirfenidone to Shionogi (approved in Japan 02/09) and InterMune (phase III trials completed in US) and wind up affairs of company
- Senior Vice President for Medical and Clinical Affairs
- Cell Works Inc.
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- Chief Medical Officer at startup biotechnology company specializing in cancer diagnostics and therapeutics; Awarded SBIR grant as principal investigator by National Cancer Institute and Orphan Drug Designation by Food and Drug Administration both for ligand directed treatment of hepatocellular carcinoma; Organized Scientific Advisory Board; Planned strategy for development of circulating cancer cell tests to detect disease recurrence and help guide therapy; Supervised clinical trials and work of contract research organizations; Prepared and reviewed legal documents; Represented company at medical society (ASCO, Prostate Cancer Foundation, MD Anderson Tumor Markers Conference, BIO) and investor meetings
- Director, Medicine Staff
- US Food and Drug Administration
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- Medical spokesperson for FDA; Accountable for FDA interface with health professionals and their organizations and with other government health agencies; Incorporated FDA objectives into Healthy People 2000 and 2010 (US National Health Goals) Chair of FDA Internal Institutional Review Board, Dramatically cut review times; Chief hearing officer for clinical investigator disqualification hearings; Advisor to HCFA (now CMS) on Medicare Coverage issues; FDA representative to AHCPR (now AHRQ) National Advisory Council; FDA representative on numerous advisory panels, both federal and non-governmental; Responsible for The FDA Medical Bulletin (circulation 700,000) and "From the FDA" columns in journals for physicians, pharmacists and nurses; Developed original materials and partners for MedWatch (FDA Medical Product Reporting Program); Increased number and quality of practitioner reports; Focal point liaison for FDA Alternative and Complementary Medicine initiatives including strategies for evaluating botanical and homeopathic compounds
- Director, Office of Drug Standards
- US Food and Drug Administration
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- Managed Divisions of Drug Advertising and Labeling (now DDMAC); Generic Drugs (now Office of Generic Drugs), Bioequivalence, Biopharmaceutics and OTC Drug Products; Implemented Drug Price Competition and Patent Term Restoration Act of 1984; Established precedents for determining patent rights and marketing exclusivity; Responsible for review of all abbreviated new drug applications speeding review through computerization and streamlining of work flow; Chaired meetings between FDA and Manufacturers on alleged violations of FDA regulations governing prescription drug promotion; FDA delegate to U.S. Pharmacopeial Convention; FDA representative to Bilateral Meetings with Japanese Drug Regulatory Authority; Consultant to National Institute for the Control of Pharmaceutical and Biological Products, Beijing, China, 1981-1989
- Acting Director, Office of Drugs
- US Food and Drug Administration
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- Managed 500 employees in compliance, drug research and testing, epidemiology, biostatistics, information systems, generic drugs, over-the-counter drugs, prescription drug promotion and biopharmaceutics
- Director, Division of Drug Advertising and Labeling
- US Food and Drug Administration
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- Responsible for regulation of all prescription drug promotion within the US; Finalized (still current) regulations for Rx Drug Advertising and Labeling; Developed precedents that have remained in effect until the present day; Initiated first FDA patient medication information program; Responsible for review of research studies supporting advertising claims; For six years, chair of Bureau-wide Committee on Advanced Scientific Education winning and maintaining ACCME and ACPE accreditation
- Zimmerly, Rheinstein and Joson, P.A.
- President
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- Organized corporation to provide medical coverage for hospital emergency rooms; Recruited and supervised physicians; Marketed program to hospital administrators and medical staffs; Met with community leaders
- Medical Director
- CHC Corporation
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- Supervised physicians and attended patients, developed medical policy for long term care facilities; Met with federal, state and local officials on regulatory matters and to express views on pending legislation and regulations.
- Physician, Instructor in Medicine
- University of Maryland School of Medicine
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- Attended patients and supervised medical students and housestaff in medical and adult cardiac clinics at University of Maryland Hospital; Physician for students and staff.
Education
- University of Maryland Francis King Carey School of Law
- J.D. (1973) | Law
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- Honors: Outstanding Brother, Taney Senate, Delta Theta Phi Law Fraternity 1971-72 and 1972-73
- Activities: President, Senior Class; Vice-President, Student Bar Association
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- Johns Hopkins University
- M.D. (1967) | Medicine
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- Teaching Assistant, Department of Biomathematics; Research Assistant, Division of Computer Research Technology, National Institutes of Health; Epidemiology Training Program, California Department of Public Health
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- Michigan State University
- M.S. (1964) | Mathematics
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- Graduate Assistant with sole responsibility for teaching "Elementary Mathematical Analysis"
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- Michigan State University
- B.A. (1963) | Mathematics
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- Completed four year curriculum in two years; President Honors College Alumni Association, 2000-2001
- Honors: Graduated from Honors College with High Honors, Phi Kappa Phi, Phi Eta Sigma, Green Helmet, Professor L.C. Plant Prize in Mathematics, Pi Mu Epsilon, General Motors Scholarship
- Activities: All University Student Government, Frosh-Soph Council
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Awards
- Biographical Listing
- Who's Who in America
- Biographical Listing
- Wikipedia
- Gold Medal
- American College of Legal Medicine
- President's Outstanding Service Award
- Academy of Pharmaceutical Physicians and Investigators
- Outstanding Service Award
- Drug Information Association
Professional Associations
- American Board of Legal Medicine
- Chairman
- - Current
- Activities: Treasurer, 2002-2011; Chairman, 2011-
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- Food and Drug Administrtion Alumni Association
- Life Member
- - Current
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- National Association of Retired Federal Employees
- Life Member
- - Current
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- Intercultural Friends Foundation
- Vice-President
- - Current
- Activities: Non-profit program brings high school students to US for homestays with American families. Details at www.iffusa.org.
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- Academy of Pharmaceutical Physicians and Investigators
- Past President
- - Current
- Activities: President, 2010-2011; President-Elect, 2009-2010; Secretary-Treasurer, 2008-2009; Board of Trustees, 1999-2003 and 2008- ; Vice President, AMA Relations, 1999- : President, Washington-Baltimore Chapter, 1999-2003
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- Annapolis Yacht Club
- Member
- - Current
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- Federal Executive Institute Alumni Association
- Life Member
- - Current
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- Chartwell Golf and Country Club
- Member
- - Current
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- District of Columbia Bar
- Member
- - Current
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- American Public Health Association
- Member
- - Current
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- Federal Bar Association
- Member
- - Current
- Activities: Chairman, Food and Drug Committee 1976-79
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- Drug Information Association
- Past President
- - Current
- Activities: President, 1984-85 and 1988-89; Vice-President 1987-88; Board of Directors, 1982-90; Annual Meeting Chair, 1991 and 1994
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- American Academy of Family Physicians
- Fellow
- - Current
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- University of Maryland Alumni Association
- Life Member
- - Current
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- Maryland State Bar Association
- Member
- - Current
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- Maryland State Medical Society
- Member
- - Current
- Activities: Delegate to US Pharmacopeial Convention, 2008-
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- American Medical Association
- Life Member
- - Current
- Activities: Member, National Task Force on CME Provider/Industry Collaboration 1992- ; Member, House of Delegates 2002- ; Member, United States Adopted Names (USAN) Council 2006-
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- American College of Legal Medicine
- Fellow
- - Current
- Activities: Treasurer 1985-88 and 1990-91 Member, Board of Governors 1983-93 and 2011-
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- American Bar Association
- Member
- - Current
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- Delta Theta Phi Law Fraternity
- Life Member
- - Current
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- Johns Hopkins University Alumni Association
- Life Member
- - Current
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- Society for Industrial and Applied Mathematics
- Life Member
- - Current
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- Michigan State University Alumni Association
- Life Member
- - Current
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- Mathematical Association of America
- Member
- - Current
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- Mensa
- Life Member
- - Current
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Certifications
- Legal Medicine
- American Board of Legal Medicine
- Geriatric Medicine
- American Board of Family Medicine
- Family Medicine
- American Board of Family Medicine
Websites & Blogs
- Website
- Wikipedia
Social Media
Contact
