Peter Rheinstein

Peter Rheinstein

Severn Health Solutions
  • Health Care Law
  • DC, Maryland
Badges
Claimed Lawyer ProfileSocial Media
Practice Area
  • Health Care Law
Jurisdictions Admitted to Practice
DC
Maryland
U.S. Supreme Court
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. / Law (1973)
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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
Johns Hopkins University
M.D. / Medicine (1967)
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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
Michigan State University
M.S. / Mathematics (1964)
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Graduate Assistant with sole responsibility for teaching "Elementary Mathematical Analysis"
Michigan State University
B.A. / Mathematics (1963)
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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
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-
Food and Drug Administrtion Alumni Association
Life Member
- Current
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.
National Association of Retired Federal Employees
Life Member
- Current
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
Annapolis Yacht Club
Member
- Current
Chartwell Golf and Country Club
Member
- Current
Federal Executive Institute Alumni Association
Life Member
- Current
District of Columbia Bar
Member
- Current
American Public Health Association
Member
- Current
Federal Bar Association
Member
- Current
Activities: Chairman, Food and Drug Committee 1976-79
American Academy of Family Physicians
Fellow
- Current
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
Maryland State Bar Association
Member
- Current
University of Maryland Alumni Association
Life Member
- Current
American Bar Association
Member
- Current
American College of Legal Medicine
Fellow
- Current
Activities: Treasurer 1985-88 and 1990-91 Member, Board of Governors 1983-93 and 2011-
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-
Maryland State Medical Society
Member
- Current
Activities: Delegate to US Pharmacopeial Convention, 2008-
Delta Theta Phi Law Fraternity
Life Member
- Current
Johns Hopkins University Alumni Association
Life Member
- Current
Society for Industrial and Applied Mathematics
Life Member
- Current
Michigan State University Alumni Association
Life Member
- Current
Mathematical Association of America
Member
- Current
Mensa
Life Member
- Current
Certifications
Diplomate
American Board of Legal Medicine
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