Oral Histories

The oral history program in the FDA History Office, which began in the mid-1970s, captures the memories of selected agency employees typically toward the end of their careers in Food and Drug. Though the program’s early focus was on agency staff directly connected to enforcement work, the History Office today collects oral histories from staff at all levels and across the agency. As a convenience to researchers, the below table contains oral history transcripts in PDF format.  You can sort the table using the arrows at the top of each column and can find particular interviews by inputting keywords in the search field.

NAME	POSITION(S) HELD	OFFICE/ CENTER	LOCATION	DATES AT FDA	PRODUCT AREAS	KEYWORDS	DATE OF INTERVIEW
Abbott, Russell J.	Deputy Commissioner for Administration	OC	DC/MD	1969-2011	Agency-wide; Operations	Management & Budget Organization & Reorganization User Fees	3/23/2011
Adams, Jennifer	Foreign Work Planner, Office of Bioresearch Monitoring Operations	ORA	DC/MD		Disaster Response; COVID-19 Public Health Emergency	COVID-19; Department of Health and Human Services (HHS); deployment; emergency response; Illinois; nursing homes; public health; White House Coronavirus Taskforce; ventilators	6/21/2021
Adams, Lois P.	Program Analyst Officer, Office of Legislation	OPPLA	DC/MD	1970-2001	Legislative Affairs	Bioethics Informed Consent Human Subjects Legislation Management & Budget Women's Health	5/1/2001
Administrators, FDA Checchi, Arthur Goldhammer, Gilbert Gough, Terrence Janssen, Wallace Kelly, Elizabeth Lofsvold, Fred McFayden, Richard Porter, Robert Ross, Nancy Smith, Ralph Young, James Harvey					Agency-wide; Operations	1962 Drug Amendments Citizens Advisory Committees Field Work Food Additives Food Standards	6/8/1978
Alfend, Sam	Director, Denver District	ORA	DENVER	1923-1964	Enforcement	1962 Drug Amendments Citizens Advisory Committees Field Work Food Additives Food Standards	6/8/1978
Anderson, Ted L.	Lead Investigator, Denver District, Springfield, MO Resident Post	ORA	DENVER	1969-2006	Enforcement	Carcinogens Inspections	6/13/2006
Bachorik, Lawrence	Assistant Commissioner for Communications	OEA	DC/MD	1978-2015	External Affairs	Public affairs Media Public information Speechwriting Communications Stakeholders	7/18/2016
Bacsanyi, Janos T.	Medical Officer in the Office of Drug Safety	CDER	DC/MD	1964-	Drugs	Drug Review Drug Safety Medical Therapy Thalidomide	1/24/2006
Baldwin, Richard	Senior Science Advisor to the Associate Commissioner for Regulatory Affairs	ORA	DC/MD	1971?-	Enforcement	Field Work Laboratory Research Training & Recruitment	9/2/2003
Banes, Daniel	Director, Office of Pharmaceutical Sciences	CDER	DC/MD	1939-1973	Drugs	Drug Safety Drug Testing Research & Instrumentation	6/17/1980
Barkdoll, Gerald L.	Associate Commissioner for Planning and Evaluation	OC	DC/MD	1971-1994	Operations	Management & Budget Policy Planning	9/30/1998
Barnard, Alfred	Director, Bureau of Regulatory Compliance	ORA	DC/MD	1941-1970	Enforcement	Field Work Inspections Quackery Training & Recruitment	5/14/1987; 6/4/1987; 3/2/1989
Bartram, M.T.	Acting Director, Division of Microbiology	NCTR	ARKANSAS	1938-1967	Toxicology	Antibiotic Certification Drug Safety Foodborne Illness Food Standards Microbiological Research	8/6/1987
Batts, Walter M.	Deputy Director, Office of International Programs	OIP	DC/MD	1972-2011	International Programs	Bioresearch Monitoring Drug Efficacy Study Foreign Posts Good Manufacturing Imports National Security Trade	12/20/2011
Beacham, Lowrie M.	Assistant to the Director, Bureau of Foods	CFSAN	DC/MD	1934-1974	Foods	Canned Foods Food Adulteration Food, Drug, & Cosmetic Act Food Standards Seafood Inspection	8/28/1985
Beard, Gary L. (joint interview with Dickinson)	Consumer Safety Officer, State Contracts Branch	ORA		1960-1997	Enforcement	Packaging & Labeling Stakeholder Engagement User Fees	11/19/1997
Beaulieu, Andrew J.	Director, Office of Minor Use & MiSpecies	CVM	DC/MD	1972-2007	Veterinary Medicine	Carcinogens Extra-Label Use Minor Use Minor Species Nutritional Lableing (Petfood)	4/16/2010
Beaulieu, Raymond D.	Food Safety Specialist, Retail Food & Interstate Travel Program	CFSAN	DC/MD	1966-1996	Foods	Foodborne Illness Food Safety	8/27/2001
Beebe, Jr., Arthur James	Regional Food and Drug Director, Northeast Region, Stoneham, MA	ORA	NORTHEAST	1956-1996	Enforcement	Field Work Good Manufacturing Industry Relations Inspections Organization & Reorganization	8/6/1997
Bellis, Tom	Secretary, Food Standards Committee	CFSAN	DC/MD	1934-?	Foods	Food Standards Inspections	7/24/1984
Belsito, Ljuca	FOIA Officer, Division of Disclosure	CDRH	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; COVID-19; deployment; Diamond Princess; emergency response; Extracorporeal Membrane Oxygenation (ECMO); Japan; Minister of Health (Japan); nurse; patient; quarantine; Rapid Deployment Force (RDF); US Public Health Service	4/28/2021
Belsky, Deborah Xu, Lei	Medical Regulatory Reviewer Medical Officer	CBER	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; contact tracing; COVID-19; deployment; medical officer; quarantine; personal protective equipment (PPE); San Francisco; SARS-CoV-2; screening; testing	6/4/2021
Berch, Irwin B.	Director, Region IX , San Francisco, California	ORA	SAN FRANCISCO	1939-1980	Enforcement	Good Manufacturing Practices Inspections Seafood	6/14/1982
Betancourt, Angela	Safety Lead Reviewer, Division of Animal Food Ingredients	CVM	DC/MD		Diversity, Equity and Inclusion	Veterinary Medicine; Animal Feed; Toxicology; Diversity & Inclusion; Hispanic Heritage	7/12/2023
Birch-Smith, Postelle Janesziewicz, Ashlee	Regulatory Officer Health Science Administrator	CDER OC	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; convalescent plasma; COVID-19; deployment; Detroit, MI; Operation Warp Speed; San Antonio, TX; Therapeutics Logistics; US Public Health Service; Washington state	4/29/2021
Blumenschein, Frederick W.*	Chief, Case Management & Guidance Branch, Office of Compliance, Division of Manufacturing & Product Quality	CDRH	DC/MD	1972-2008	Drugs	Filth Good Manufacturing Practices Toy Safety	6/24/2008
Bork, George†	Labor Relations Specialist	ORA		1963-2003	Enforcement	Field Work Labor Relations NTEU	9/16/2003
Bosin, Morris R. (Butch)	Director of Planning Staff	OPPLA	DC/MD	1979-2003	Operations	Imports Inspections Legislation Planning	7/29/2003
Boudreaux, Edwin C.	Director, New Orleans District	ORA	NEW ORLEANS	1922-1965	Enforcement	Field Work Fraud Cases Inspector Training & Recruitment Seafood Inspection	5/15/1978
Brandenburg, Robert C.	Director, Compliance Regulations and Policy Staff	OPPLA	DC/MD	1946-1976	Enforcement	Cancer Fraud Congressional Affairs Legal Cases	11/4/1982
Brau, Jr., Mario	Assistant Collector of Customs – No interview – Paper on the History of the San Juan, Puerto Rico Station	NON-FDA	PUERTO RICO	N/A	Enforcement	Field Work Imports Inspections	1/1/1984
Bressler, Jerome	Director, Compliance Branch, Chicago District	ORA	CHICAGO	1942-1984	Enforcement	1962 Drug Amendments Cancer Fraud Field Work Inspections Tylenol Tampering	4/23/1999
Brodsky, Philip (joint interview with Maraviglia)	Investigator, Drug Specialist			1951-1977	Drugs	Inspections Field Work Training & Recruitment Planning Thalidomide	9/11/1981
Bryant, Jr., Willie R.	Senior Recall Officer, Office of Enforcement, Division of Compliance, Management, and Operations	ORA	DC/MD	1963-	Enforcement	Counterfeit Drugs Good Manufacturing Practices Inspections Field Work Tampering Recalls	6/16/2005
Buc, Nancy	Associate General Counsel, Food and Drug Division; Chief Counsel, Food & Drug Administration	OCC	DC/MD	1980-1981	Legal Affairs	Food and drug law Office of General Counsel Departmental relations Congressional affairs	8/12/2015
Burke, Jerry A.	Deputy Director, Systems and Support	CFSAN	DC/MD	1959-1992	Foods	Food Additives Organization & Reorganization Pesticides	7/22/1993
Cangelosi, Robert, J. (joint interview with Carstenson)	Branch Chief, Human Factors, Engineering, Science Branch	CDRH	DC/MD	1971-2006	Medical Devices	Cardiac Devices Congressional Affairs Good Manufacturing Practices Medical Devices Radiology	3/9/2009
Carnevale, Catherine W.	Director, International Affairs	CFSAN	DC/MD	1975-2008	Foods	Color Additives Contamination Food Additives Pesticides Trade	2/10/2009
Carol, Jonas (speech)	Analytical Chemist			1930-1969		Drug Standards Patent Medicines Penicillin Quackery	5/31/1950
Carstenson, Peter B.* (joint interview with Cangelosi)	Mechanical Engineer	CDRH	DC/MD	1964-2008	Medical Devices	Cardiac Devices Congressional Affairs Emergency Care Engineering Medical Devices Device Standards	3/9/2009
Caulk, Nathan	Senior Regulatory Program Manager	CDER/OPQ	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; contact tracing; COVID-19; deployment; Indian Health Service (IHS); JFK Airport; North Carolina; nurse; patients; Public Health Service (PHS); quarantine station; testing; vaccine	3/19/2021
Cavers, David F.	Dean, Harvard School of Law	NON-FDA			Legal Affairs		2/15/1967
Celeste, Anthony C.	Deputy Director, Office of Regional Operations	ORO	DC/MD	1960-1985	Enforcement	Field Work Inspections Narcotics	10/5/1994 & 11/2/1994
Checchi, Arthur A.-- See also Administrators, FDA	Assistant to the Deputy Commissioner	OC	DC/MD	1945-1959	Agency-wide	1962 Drug Amendments Cancer Fraud Carcinogens Citizens Advisory Committees Enforcement Field Work Food Standards Inspections Training & Recruitment	7/24/1984
Chesemore, Ronald G.	Associate Commissioner for Regulatory Affairs	ORA	DC/MD	1979-1999	Enforcement	Criminal Investigations Drug Review Field Work Generic Drug Scandal Organization & Reorganization Training & Recruitment	7/7/1999
Clark, William R.	Regional Food and Drug Director, Midwest Region, Chicago, IL	ORA	CHICAGO	1959-1989	Enforcement	Consumer Education Field Work Information Technology Tylenol Tampering	1/30/1995
Claunts, Frank P.	Finance Coordinator for the Food and Drug Administration User Fee Program		DC/MD	1972-	Operations	Congressional Affairs Management & Budget User Fees Tobacco	12/8/2006
Clem, J. David	Chief, Shellfish Sanitation Branch	CFSAN?			Foods	Seafood/Shellfish	10/25/1994
Cohen, Wilbur J.	Secretary, Department of Health, Education and Welfare	NON-FDA	DC/MD	n/a	Department	1962 Drug Amendments Medicare Thalidomide	9/29/1973
Cook, J. William	Director, Division of Pesticide Chemistry and Toxicology	CFSAN?	DC/MD	1939-1972	Toxicology	Enforcement Field Work Filth Inspections Natural Disasters Prescription Drugs	6/18/1980
Cook, Nevis E.	Director, New Orleans District	ORA	NEW ORLEANS	1939-1972	Enforcement	International Affairs Pesticides Research & Instrumentation	4/26/1977
Coppinger, Paul L.	Associate Commissioner for Planning and Evaluation	OPPLA	DC/MD	1970-2000	Operations	1962 Drug Amendments Drug Efficacy Study Legislation Management & Budget Policy User Fees	6/30/2001
Corwin, Emil	Press Relations Officer	CFSAN	DC/MD	1964-	External Affairs	Congressional Affairs Internal Communications Press Relations	8/27/2003
Cromartie, A.D.	Administration & inspection, Insecticide Division, Department of Agriculture; Enforcement & Inspection, Insecticide Division, USDA	USDA	DC/MD	1931-1966	Foods	Adulteration Appropriations Contamination Factory Inspections Food, Drug, & Cosmetic Act Pesticide Toxicology	3/26/1973
Cron, Theodore	Assistant Commissioner for Education & Information	OC	DC/MD	1966-1989	External Affairs	Consumer Affairs Equal Employment Opportunity Internal Communications Press Relations	11/8/2004
Crout, J. Richard	Director, Bureau of Drugs	CDER	DC/MD	1971-1982	Drugs	Advisory Committees Antibiotics Carcinogens Drug Efficacy Study Generic Drugs Orphan Drugs Policy Tobacco User Fees	11/12/1997
Dawson, Raymond K.	Director, Division of Planning, Evaluation & Management	OPPLA	DC/MD	1963-1996	Operations	Carcinogens Management & Budget Planning User Fees	5/8/1996
Derfler, Philip	Associate Chief Counsel for Foods	CFSAN	DC/MD	1979-1997	Foods	Dietary Supplements Food Additives Freedom of Information Infant Formula Legal Affairs Nutritional Labeling Pesticides Policy Tobacco	10/28/1998
Dick, Robert H.	Supervisory Tea Examiner	CFSAN	DC/MD	1937-	Foods	Coffee Seafood Tea	3/23/1984
Dickinson, Robert E. (with Beard)	Consumer Safety Officer, State Contracts Branch	ORA	DC/MD	5/1966-8/1997		Packaging & Labeling Stakeholder Engagement User Fees	11/19/1997
Dickerman, Arthur A.	Principal Attorney	OCC	DC/MD	1942-1970	Legal Affairs	Legal Affairs Penicillin	1/28/1981
DiDonna, Danielle	Regulatory Officer, Division of Import Operations	ORA	LONG BEACH, CA		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; contact tracing; COVID; COVID-19; deployment; emergency response; FDA Commissioned Officers Network (FCON); Florida; hospital; Public Health Service (PHS); testing	3/10/2021
Dykstra, Gary†	Regional Food and Drug Director, Southeast Region	ORA	SOUTHEAST	1967-2007	Enforcement		6/27/2008
Eisenberg, William V. See also Scientists I	Assistant Director, Division of Microbiology	NCTR	ARKANSAS	1937-1980	Toxicology	Drug Safety Filth Food Standards Microbiology Research & Instrumentation	7/25/1984
Ellenberg, Susan S.	Director, Office of Biostatistics & Epidemiology	CBER	DC/MD	1988?-	Biologics	AIDS/HIV Biologics Clinical Trials Vaccines	12/7/2004
Ellenbogen, Theodore	Deputy Chief of the General Counsel's Office of the Department of Health, Education, and Welfare	HEW	DC/MD	1947-1969	Department	1962 Drug Amendments Consumer Protection Food Additives Legal Affairs	3/1/1974
Ernst, Walter A.	Planning Officer, Bureau of Program Planning & Appraisal	OPPLA	DC/MD	1929-1963	Operations	Cancer Fraud Health Food Fraud Planning Management & Budget	3/20/1979
Eshelman, Robert A.	Leading Expert, Division of New Drugs & Labeling Compliance, Office of Compliance	CDER	DC/MD	1966-2008	Drugs	Adverse Events Drug Efficacy Study OTC Drug Review Research & Instrumentation User Fees	12/14/2007
Feather, Kenneth R.	Regulatory Review Officer	ORA		1962-1997	Enforcement	Drug Advertising Field Work	5/7/1997
Ferrante, Marion	Program Support Specialist, New Orleans District Office, Temporarily Relocated to Nashville, TN	ORA	NEW ORLEANS	1966-2008	Emergency Response	Hurricane Katrina Natural Disasters Field Work	9/11/2007
Field, Oliver F.	Director, Bureau of Investigation, American Medical Association	AMA	CHICAGO	1943-1947	Drugs	Cancer Fraud Drug Fraud Health Food Fraud Medical Therapy	6/12/1982
Fine, Sam D.	Associate Commissioner for Compliance	ORA	DENVER	1939-1976	Enforcement	Citizens Advisory Committees Investigations Field Work Filth Organization & Reorganization Research & Instrumentation	5/11/1978
Fink, Marie	Recall & Compliance Coordinator, New Orleans District Office, Metairie, LA Resident Post	ORA	NEW ORLEANS	1990-	Emergency Response	Hurricane Katrina Natural Disasters Field Work	9/26/2007
Finlayson, John S.	Associate Director for Science, Office of Blood Research & Review	CBER	DC/MD	1958-2004	Biologics	AIDS/HIV Biologics Hepatitis C Vaccines Orphan Drugs User Fees	6/11/2009
Fischbach, Henry – See Scientists II	Director, Division of Food Chemistry	CFSAN	DC/MD		Foods	Contamination Dietary Supplements Filth Research & Instrumentation Seafood	12/7/1979
Fischelis, Robert P.	Secretary, American Pharmaceutical Association	NON-FDA			Drugs	1962 Drug Amendments Drug Standards Narcotics Pharmaceutical Industry Prescription Drugs	9/17-19/1968
Fishbein, Morris	Editor, Journal of the American Medical Association	NON-FDA	CHICAGO		Drugs	1962 Drug Amendments Consumers Elixir Sulfanilamide Food, Drug, & Cosmetic Act Medical Costs Patent Medicines Quackery	3/12/1968
Fitzhugh, O., Garth -  See Pharmacologists	Pharmacologist, Division of Pharmacology	CDER	DC/MD		Drugs	Contamination Elixir Sulfanilamide Food Additives Pesticides Radiation Research & Instrumentation Toxicology	6/20/1980
Flaherty, Francis J.	Director, Strategic Initiative Staff			1962-1999		Drug Safety Field Work Generic Drug Scandal Narcotics	6/14/2000
Frater, Robert	Cardiothoracic Surgeon, St. Jude's Medical Center	N/A			Medical Devices	Heart valve replacement surgery Mitral valve prosthesis Cardiac surgery Medical device standards	05/2003
Gardner, Susan	Director, Office of Surveillance and Biometrics	CDRH	DC/MD	1995-2011	Medical Devices	Clinical Trials Combination Products Epidemiology Medical Devices Statistics	6/22/2011
Garfield, Frederick-- See Scientists I	Assistant Director, Bureau of Narcotics and Dangerous Drugs, Office of Science and Technology		DC/MD		Drugs	Congressional Affairs Drug Standards Enforcement Inspections Food Additives Microbiology Organization & Reorganization Research & Instrumentation	6/29/1978
Geismar, Lee	Reviewing Chemist, Team Leader	CDER	DC/MD	1947-1997	Drugs	1962 Drug Amendments Drug Review Thalidomide User Fees	4/30/1997
George, Barbara	Program Support Specialist, New Orleans District Office, Temporarily Relocated to Nashville, TN	ORA	NEW ORLEANS	1973-2008	Emergency Response	FEMA Field Work Hurricane Katrina Hurricane Ivan Hurricane Rita Natural Disasters	9/12/2007
German, Gary E.	Director, Division of Human Resource Development, Office of Resource Management	OO	DC/MD	1985-2010	Operations	Training & Recruitment	1/26/2010
Glavin, Margaret, O’K.--See also NLEA	Associate Commissioner for Regulatory Affairs	ORA	DC/MD	2003-2008	Enforcement	Counterterrorism Food Safety National Security Recalls User Fees	10/1/2008
Goddard, James L.	Commissioner, Food and Drug Administration	OC	DC/MD	1966-1968	Agency-wide	Drug Advertising Generic Drugs Inspections Management & Budget Pharmaceutical Industry Planning	4/30/1969
Goldhammer, Gilbert - See Administrators, FDA	Assistant Director, Bureau of Regulatory Operations	ORA	DC/MD		Enforcement	Citizens Advisory Committees 1962 Drug Amendments Field Work Food Additives Food Standards	6/30/1978
Goldkind, Sara, M.D.	Senior Bioethicist, Office of the Commissioner	OC	DC/MD	2003-2014	Agency-wide	Bioethics Children Clinical Trials Informed Consent Good Clinical Practices Policy Research & Instrumentation	6/29/2014
Goodrich, William W.	General Counsel, Food and Drug Administration	OGC	DC/MD	1939-1971	Legal Affairs	1962 Drug Amendments Cancer Fraud Dietary Supplements Drug Advertising Food Additives Food Standards GRAS Narcotics	10/15/1986
Gough, Terrance - See Scientists I
Gorton, Charles	Director of Planning & Management Communications, Office of Planning & Evaluation	OPPLA	DC/MD	1974-1997	Operations	Management & Budget Planning Training & Recruitment	12/3/1997
Graham, Ballard	Director, Atlanta District	ORA	ATLANTA	1970-2002	Enforcement	Field Work Generic Drug Scandal	6/17/2003
Grant, Alexander	Associate Commissioner, Office of Consumer Affairs	OEA	DC/MD	1972-1997	External Affairs	Consumer Education Food Labeling Stakeholder Engagement Tobacco	1/15/1997
Gray, Stephanie	Director of Compliance	CDER	DC/MD	1972-2000	Drugs	Counterfeit Drugs Infant Formula Gender Factor Good Manufacturing Practices	4/11/2000
Greenwald, Peter	Director of the Division of Cancer Prevention, National Cancer Institute (NIH)	NIH	DC/MD	1981-2011	Foods	nutritional science dietary fiber health claims Kellogg’s All Bran cancer National Cancer Institute	8/26/2009
Griffin, Edward Lawrence	Administrative position in enforcement and inspection at the Insecticide Division, U.S. Dept. of Agriculture	USDA	DC/MD	1913-1955	Foods	Appropriations Consumer Affairs Food, Drug, & Cosmetic Act Inspections Research & Instrumentation Pesticides Toxicology	1/31/1973
Gross, Richard E.	Assistant Director for Liaison, Office of Health & Industry Programs	CDRH	DC/MD	1968-1998	Medical Devices	Mammography Quality Assurance Radiation Three Mile Island X-ray Standard	1/20/1999
Guerra, Connie H.	Director, Office of Information Technology	OC	DC/MD	1978-2008	Operations	Information Technology Management & Budget Planning	6/5/2008
Guilford, Claudette	Director, Consumer Affairs and Information Staff	OEA	DC/MD	1968-1994	External Affairs	Consumer Affairs Equal Employment Opportunity Nutritional Labeling Stakeholder Engagement	7/28/1994
Guill, John H.	Regional Assistant Commissioner, Region IX, San Francisco, CA	ORA	SAN FRANCISCO	1939-1973	Enforcement	Field Work Filth	3/1/1978
Haffner, Marlene, M.D., MPH	Director, Orphan Products Development	CDER	DC/MD	1981-2007	Drugs	AIDS/HIV Drug Safety Grants & Contracts Medical Devices Orphan Drugs	3/13/2012
Haggard, David	Director, Division of Compliance, Office of Enforcement	ORA	DC/MD	1968-2001	Enforcement	Field Work International Affairs Investigative Procedures Laboratory Procedures Policy Regulatory Procedures	5/30/2001
Halperin, Jerome A.	Deputy Director of the Bureau of Drugs, and Assistant Surgeon General in the U.S. Public Health Service	CDER;PHS	DC/MD		Drugs		1/22/2013
Hansen, Douglas C.	Regional Assistant Commissioner, CPEHS, Seattle, Washington	ORA	SEATTLE	1942-1968	Enforcement	Field Work Inspections Training & Recruitment	9/26/1978
Hansen, Kenneth A.	Director, Seattle District	ORA	SEATTLE	1959-1986	Enforcement	Field Work Inspections Imports Pesticides Training & Recruitment	6/13/1990
Hardin, Nicole	Compliance Officer, New Orleans District Office, Metairie, LA Resident Post	ORA	NEW ORLEANS	1965-	Emergency Response	Field Work Hurricane Katrina Natural Disasters	9/25/2007
Harris, Kenton L.	Special Assistant to the Director, Bureau of Biological and Physical Sciences		DC/MD	1937-1966		Filth Inspections	10/30/1991
Hart, Samuel	Director, Bureau of Product Safety		DC/MD	1956-1973		Consumer Products	1/9/1992
Healton, Donald G.	Regional Food and Drug Director, Pacific Region, Oakland, CA	ORA	OAKLAND	1955-1994	Enforcement	Field Work Information Technology Organization & Reorganization Research & Instrumentation	6/19/1995
Heckman, Jerome (Jerry) H.	Lawyer, Keller & Heckman	NON-FDA	DC/MD		Legal Affairs	Carcinogens Food Additives Legal Affairs Plastics	8/10/2006
Henderson, Marsha B.	Associate Commissioner for Women's Health	OC	DC/MD	1998-2018	Women's Health	Sex as a biological variable Heart disease Clinical trials Mammography Stakeholder engagement Contraception	12/19/18
Henney, Jane	Deputy Commissioner for Operations	OC	DC/MD	1992-1994	Operations	Breast Implants Cancer Criminal Investigations Field Work Research & Instrumentation	3/28-29/1994
Herrmann, Charles A.	Director, New York District	ORA	NEW YORK	1920-1966	Enforcement	Imports Inspections Organization & Reorganization Training & Recruitment	7/11/1978
Hildwine, Regina - See NLEA	National Food Processors Association	NON-FDA			Foods	Consumer Education Food Labeling Nutritional Facts	1/31/2003
Hile, Joseph Paul (1)	Associate Commissioner for Regulatory Affairs	ORA	DC/MD	1958-1986	Enforcement	Field Work Filth Good Manufacturing Practices Industry Relations Inspections Management & Budget Training & Recruitment	10/22/1986
Hile, Joseph Paul (2)	Associate Commissioner for Regulatory Affairs	ORA	DC/MD	1958-1986	Enforcement	Administrative Procedures Canned Foods Good Labor Practices Infant Formula Package Inserts Reorganization Research & Instrumentation Tampons Tylenol Tampering	8/4/1988
Hill, William C.	Director, San Francisco District	ORA	SAN FRANCISCO	1948-	Enforcement	Cancer Fraud Congressional Affairs Counterfeit Drugs Drug Review Field Work Filth Inspections Natural Disasters	6/15/1982
Hinz, Carla O'Carroll, Andrew	Program Manager Medical Regulatory Reviewer	FDA CBER	CENTRAL DC/MD		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; COVID-19; Deployment; Javits Center; mortuary; New York; Patients; Personal Protective Equipment (PPE); Rapid Deployment Forces (RDF); Strike Team; US Public Health Service	4/20/2021
Hoeting, Alan L.	Director, Office of Enforcement	ORA	DC/MD	1957-1992	Enforcement	Child Protection Act Congressional Affairs Counterfeit Drugs Elixir Sulfanilamide Environmental Health Field Work Generic Drug Scandal Medicated Feeds Nutritional Labeling Recalls Tampering	4/21/1999
Holness, Leslie	Chief, Division of Blood Applications, Office of Blood Research & Review	CBER	DC/MD	1991-2013	Biologics	Blood HIV/AIDS Nucleic Acid Test American Red Cross	1/1/2013
Holston, Sharon Smith	Deputy Commissioner for International & Constituent Relations	OIP	DC/MD	1972-2001	International Programs	Civil Rights Criminal Investigations Equal Employment Opportunity Generic Drug Scandal Information Technology International Affairs Management & Budget Organization & Reorganization Planning	11/27/2001
Hooker, Thomas L.	Director, Baltimore District	ORA	BALTIMORE	1964-1993	Enforcement	Field Work	12/16/1994
Horwitz, William	Director, Scientific Policy Staff	CFSAN	DC/MD	1939-	Foods	Court Work Field Work Filth Information Technology Inspections Organization & Reorganization Research & Instrumentation	7/25/1983
Horton, Linda R.	Advisor to Acting Deputy Commissioner Murray Lumpkin		DC/MD	1968-2001		International Relations Imports Case Work Legislation Mutual Recognition Agreement	12/18/2001
Hubbard, William K. - See also NLEA	Associate Commissioner for Policy and Planning	OC	DC/MD	1979-2005	Operations	AIDS/HIV Breast Implants Dietary Supplements Legislation Management & Budget Planning Policy Rule Making User Fees	7/27/2005
Hurricane Katrina Ferrante, Marion Fink, Marie George, Barbara Hardin, Nicole LeRay, David J. Sanchez, Carol Thornburg, Tyler Trepagnier, Tim		ORA	NEW ORLEANS		Emergency Response	Natural Disasters	09/2007
Hurricane Katrina, Atlanta District (with Phillip Campbell, Laurie Farmer, and Barbara Wood)		ORA	ATLANTA		Emergency Response	Natural Disasters	9/28/2007
Ishimoto, Janet	Chief, Program Surveillance Branch, Office of Compliance & Biologics Quality	CBER	DC/MD	1991-2015	Biologics	blood banking biologics inspections reporting information technology	2/1/2015
Jacobson-Kram, David	Associate Director for Pharmacology & Toxicology, Office of New Drugs	CDER	DC/MD	2003-2014	Drugs	DNA Toxicology Office of New Drugs drug review	3/1/2014
Janssen, Wallace F. - See also Scientists I	Director, Office of Public Information; Historian	OPI/OEA?	DC/MD	1950-	External Affairs	Citizens Advisory Committees Consumer Affairs Communications Press Relations	1/31/1984
Jiggens, Timothy	Environmental Health Officer, Office of the Chief Scientist	OC	DC/MD		Disaster Response; COVID-19 Public Health Emergency	COVID-19, community-based testing, Wuhan, Technical Assistance Team (TAT), safety officer, Commissioned Corps, US Public Health Service, billeting, repatriation, PPE	3/17/2021
Jones, Betty L.	Deputy Director, Office of Compliance	CDER	DC/MD	1972?-?	Drugs	Adverse Events Cancer Fraud Congressional Affairs Consumer Affairs Drug Review Inquiries Enforcement Equal Employment Opportunity Training & Recruitment	12/28/2004
Jones, Boisfeuillet	President, Emily and Ernest Woodruff Foundation	NON-FDA				1962 Drug Amendments Cancer Fraud Citizens Advisory Committees Congressional Affairs	1/26/1968
Kallet, Arthur†	Consumers' Research; Consumers Union	NON-FDA		1933-			11/18/1968
Katz, Russell G., M.D.*	Director, Division of Neurology Products	CDRH	DC/MD	1983-2013	Medical Devices	Adverse Events Advisory Committees Clinical Trials Drug Review Information Technology Neurological Products User Fees	6/21/2013
Kedzior, John A.	Chief, Industry Guidance Branch	ORA	DENVER	1939-1974	Enforcement	Adulterated Foods Communications Counterfeit Foods Press Relations Voluntary Compliance	6/12/1982
Kelly, Elizabeth - See Administrators, FDA and Scientists I	Librarian	OO	DC/MD		Operations	Citizens Advisory Committees 1962 Drug Amendments Field Work Food Additives Food Standards	6/30/1978
Kelsey, Frances†	Director, Investigational Drugs; Director, Division of Scientific Investigations	CDER	DC/MD	1960-	Drugs
Kennedy, Donald	Commissioner of Food and Drugs	OC	DC/MD	1977-1979	Agency-wide	Advisory Committees Carcinogens Congressional Affairs Contamination Food Additives Media Medicated Feed Reproductive Health Tobacco User Fees	6/17/1996
Kennedy, Donald	Commissioner of Food and Drugs	OC	DC/MD	1977-1979	Agency-wide	FDA Commissioner Saccharin Medicated animal feeds Antibiotics Food labeling Delaney Clause Drug Regulation Reform Act	9/17/2014
Kessler, David	Commissioner of Food and Drugs	OC	DC/MD	1990-1997	Agency-wide	Nutrition facts label Tobacco Women’s Health HIV/AIDS Food labeling	11/24/2015
Kimlel, J. Edward	Deputy Director, Western District	ORA	WESTERN	1918-1949	Enforcement	Field Work Filth Fraud Cases Inspections Pesticides Training & Recruitment	10/11/1978
Kincaid, Caleb*	Radiation Safety Officer	CDRH		1960-1979	Medical Devices	Medical Devices Radiation Three Mile Island X-rays	1/26/1996
Kingma, Fred J.	Deputy Director, Bureau of Veterinary Medicine	CVM	DC/MD	1957-1980	Veterinary Medicine	Antimicrobial Resistance Medicate Feed Veterinary Devices Veterinary Medicine	2/28/1990
Kingsley, Thomas H.	Consumer Safety Officer			1948-1988	Enforcement	Health Food Fraud Inspections Narcotics Natural Disasters Organization & Reorganization	11/18/1991
Kinslow, Maurice D. (1&2)	Regional Food and Drug Director, Region IV, Atlanta, GA	ORA	ATLANTA	1961-	Enforcement	Field Work 1962 Drug Amendments Organization & Reorganization	9/18/1982
Kirk, J. Kenneth	Associate Commissioner for Compliance		DC/MD	1930-1969	Enforcement	Carcinogens Citizens Advisory Committees Reorganization Pesticides	5/2/1979
Kline, Oral Lee - See Scientists II	Assistant Commissioner for Science	OC	DC/MD			Contamination Dietary Supplements Filth Research & Instrumentation Seafood	12/7/1979
Koegler, Dorothy H.	Director, Public Inquiry Office		DC/MD	1941-1968	External Affairs	Communications Consumer Affairs Freedom of Information Press Relations	2/4/1980
Kunkel, John L.	Director, Information Technology, Central Region, Field Servicing Center, Office of Shared Services.	ORA	CENTRAL	1972-2005	Enforcement	Good Manufacturing Practices Information Technology Medical Devices	6/19/2006
Landa, Michael M., J.D.*	Director, Center for Food Safety and Applied Nutrition	CFSAN	DC/MD	1978-2000; 2004	Foods		3/9/2015
Larrick, George P.	Commissioner, Food and Drug Administration	OC	DC/MD	1922-1965	Agency-wide	1962 Drug Amendments Drug Advertising Elixir Sulfanilamide Industry Relations Narcotics Prescription Drugs	1/2/1968
Larson, Sterk	Director, Program Planning & Workforce Management Branch	OO	DC/MD	1959-?	Operations	Compliance Consumer Education Field Work Information Technology Organization & Reorganization Planning	6/2/1992
Laug, Edwin P. - See Pharmacologists and Scientists II	Chief, Special Investigations Branch, Division of Pharmacology	CDER	DC/MD		Drugs	Carconigens Contamination Dietary Supplements Elixir Sulfanilamide Food Additives Pesticides Radiation Research & Instrumentation Toxicology	6/20/1980
Leggett, Cynthia C.	Senior Public Affairs Specialist	OC	DC/MD	1971-?	External Affairs	Advisory Committees Communications Field Work Food Safety Press Relations	12/22/2003
LeRay, David J.	Supervisory Consumer Safety Officer, New Orleans District Office, Metairie, LA Resident Post	ORA	NEW ORLEANS	1990-	Emergency Response	Field Work Hurricane Katrina Natural Disasters Water Contamination	9/26/2007
Levine, Arthur	Deputy Chief Counsel for Litigation	OCC	DC/MD	1970-1991	Legal Affairs	Food and drug law Office of Chief Counsel Office of General Counsel Enforcement litigation	12/6/2016
Levitt, Joseph A. - See also NLEA	Director, Center for Food Safety and Applied Nutrition	CFSAN	DC/MD	1978-2003	Foods	Emergency Response Food Labeling Food Safety Generic Drug Scandal Organization & Reorganization Reporting Radiology Tobacco User Fees	12/23/2003
Ley, Herbert L.	Commissioner, Food and Drug Administration	OC	DC/MD	1966-1969	Agency-wide	1962 Drug Amendments Antibiotics Drug Effica cy Study Informed Co nsent Narcotics Organization & Reorganization Tobacco	12/15/1999
Link, David	Director, Bureau of Medical Devices	CDRH	DC/MD	1970-1980	Medical Devices	Cardiac Devices Intraocular Lenses Legislation Medical Devices Quackery	9/24/2003
Lofsvold, Fred L. - See also Scientists I and Scientists II	Regional Food and Drug Director, Region VIII, Denver, CO.	ORA	DENVER	1939-1980	Enforcement	1962 Drug Amendments Counterfeit Drugs Drug Review Food Standards Inspections Training & Recruitment Organization & Reorganization Planning	8/25/1981
Love, Burton I.	Regional Food and Drug Director, Midwest Region, Chicago, IL	ORA	CHICAGO	1966-1996	Enforcement	Congressional Affairs Field Work Imports Medical Devices Narcoti cs Tobacco Toxicology	9/11/1996
Lynch, Harry P.	Director, Investigations Branch, San Juan District	ORA	PUERTO RICO	1955-?	Enforcement	Field Work Filth Indus try Relations Inspections Meat Packing	4/2/1984
MacFadyen, Richard - See Scientists I							5/1/2014
Maraviglia, Theodore C. (joint interview with Brodsky)	Regional Food and Drug Director, Region III, Philadelphia, PA	ORA	PHILADELPHIA	1935-1976	Enforcement	Field Work Inspections Planning Thalidomide Training & Recruitment	9/11/1981
Marks, Norman	Senior Medical Advisor, OHCA	OEA	DC/MD	1998-2014	External Affairs	MedWatch Adverse event reporting Health information technology Public safety Community medicine	2/6/2015
Maryanski, James	Food Biotech Specialist	CFSAN	DC/MD	1977-2006	Foods	Food Additives Genetic Engineering Irradiation Veterinary Medicine	8/18/2006
McCallion, Joseph L.	Special Assistant, Office of Regional Operations			1977-2007	Enforcement	Adulterated Foods Bioterrorism Field Labora tories Imports Research & Instrumentation	12/16/2007
McManus, John J. (joint interview w/ Schiffman)	Director, Atlanta District	ORA	ATLANTA	1908-1953	Enforcement	Field Work Fraud (legal standard) Inspections Training & Recruitment	5/10/1968
Merkatz, Ruth	Director, Office of Women's Health	OC	DC/MD	1994-1996	Women's Health	clinical trials contraception HIV/AIDS mammography gender differences in health silicone breast implants	10/16/19
Merrill, Richard A. (1)	Chief Counsel, Food and Drug Administration	OCC	DC/MD	1974-	Legal Affairs	Advisory Committees Congressional Affairs Carcinogens Case Work Contamination Legislation Rulemaking	7/12/2004
Merrill, Richard A. (2)	Chief Counsel, Food and Drug Administration	OCC	DC/MD	1974-	Legal Affairs	Administrative Procedures Case Work	11/12/2004
Meyer, Gerald F.	Deputy Director, Center for Drug Evaluation and Research	CDER	DC/MD	1972-1994	Drugs	Biologics Congressional Affairs Drug Approval Generic Drugs Organization & Reorganization Package Inserts User Fees	5/24/1995
Meyer, Lois M.	Consumer Affairs Officer, Buffalo District	ORA	BUFFALO	1964-1994	Enforcement	Consumer Education Labeling Recalls Stakeholder Engagement Training & Recruitment	7/10/1987
Meyers, Lorena	Consumer Affairs Officer	ORA	KANSAS CITY	1959-1984	Enforcement	Consumer Education Organization & Reorganization Stakeholder Engagement	6/21/1990
Michels, Daniel L.	Director, Office of Enforcement	ORA	DC/MD	1963-2000	Enforcement	Congressional Affairs Drug Review Tobacco	6/6/2000
Miller, David J.	Deputy Director, Division of Color and Cosmetics	CDER	DC/MD	1934-1969	Drugs; Colors; Cosmetics	Carcinogens Color Additives	3/28/1990
Miller, Lloyd C.	Pharmacologist	ORA	DENVER	1935-1943	Enforcement	Cosmetics Drug Standards Pharmacology Research & Instrumentation Toxicology	1/27/1981
Milstead, Kenneth L.	Special Assistant to the Commissioner	OC	DC/MD	1935-1966	Agency-wide	1962 Drug Amendments Citizens Advisory Committees Enforcement Field Work Fraud Organization & Reorganization Planning	2/4/1982
Mitchell, George A.	Associate Director for Policy & Regulations	CVM	DC/MD	1988-2001	Veterinary Medicine	Animal Drugs Canadian Trade Medicated Feed Veterinary Medicine	6/26/2001
Mlecko, Raymond A.	Director, Chicago District	ORA	CHICAGO		Enforcement	Field Work Labor Unions OTC Drug Review	6/15/2003
Moats, Richard A.	Director, State Services Branch, Division of Federal-State Relations	ORA	DC/MD	1973-1988	Enforcement	Environmental Health Health Fraud Medicated Feed Organization & Reorganization	7/20/1994
Monfore, Kenneth E.	Director, Seattle District	ORA	SEATTLE	1929-1967	Enforcement	Filth Fraud Inspections Pesticides	4/2/1979
Morrison, James C.	Senior Advisor, Center for Drugs, Evaluation and Research	CDER	DC/MD		Drugs	AIDS/HIV Drug Lag Field Wo rk Generic Drug Scandal User Fees	9/23/2003
Morton, Arnold N.	Director, Investigational Branch, New York District	ORA	NEW YORK	1939-1970	Enforcement	Field Work Fraud Information Technology Inspections	8/7/1979
Moses, Walter (1)	Chief, Food Case Branch, Division of Case Guidance	CFSAN?	DC/MD	1937-1970	Foods	Case Work Inspections Tea	5/21/1987
Moses, Walter (2)	Chief, Food Case Branch, Division of Case Guidance, Bureau of Compliance	CFSAN?	DC/MD	1937-1970	Foods	Compliance Inspections	8/28/1995
Nakada, James	Assistant Regional Director, Compliance, Region IX, San Francisco	ORA	SAN FRANCISCO	1951-1982	Enforcement	Contamination Field Work Inspections Training & Recruitment Organization & Reorganization Pesticides	6/16/1982
Neidelman, Steven M.	Deputy Associate Commissioner & Chief Operating Officer	ORA	DC/MD	1972-2006	Enforcement	Court Work Criminal Investigations Imports Inspections Training & Recruitment	11/13/2007
Nesselhauf, Robert J.	Investigator Specialist in Biologics out of St. Louis Resident Post	ORA	ST. LOUIS	1972-2004	Enforcement; Biologics	AIDS/HIV Biologics Blood Drugs Investigations	6/23/2006
Nguyen, Maria Pham, Quocbao	Senior Health Promotions Officer Research Officer	CDER	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Buffalo, NY; Commissioned Corps; COVID-19; deployment; FEMA; Indian Health Service (IHS); Kirkland, WA; mass vaccination site; nursing homes; patients; Personal Protective Equipment (PPE); Public Health Service (PHS); vaccines; Whiteriver, AZ	5/20/2021
Nightingale, Stuart L., M.D.†	Assistant to the Director, Bureau of Drugs; Associate Commissioner for Health Affairs	CDER; OC	DC/MD	1976-2000	Drugs; Agency-wide		4/7/2009
Nutrition Labeling and Education Act (NLEA) 10thAnniversary Glavin, Margaret, O'k. Hildwine, Regina Hubbard, William Levitt, Joseph Rados, William			DC/MD		Foods	Food Labeling Nutrition	1/31/2003
Oliver, Janice F.	Deputy Director for Operations	CFSAN	DC/MD	1968-2009	Foods	Dietary Supplements Nutritional Labeling Women at FDA	7/28/2009
Olson, Michael C.	Director, Division of Field Science	ORA	DC/MD		Enforcement	Inspections Training & Recruitment Research & Instrumentation	7/27/2004
O'Neill, Robert T., PhD (joint informal interview with Robert Temple)	Director, Office of Biostatistics	CDER	DC/MD	1971-2011	Drugs	AIDS/HIV Clinical Trials International Affairs Minority Health Statistics Tobacco User Fees	5/27/2011
Oser, Bernard, Ph.D.	President, Director & Chairman Food Research Laboratories	N/A	NYC	1926-1976	Foods	Toxicology Food additives Color additives Delaney Clause Carcinogens Laboratory animals Research methodology	8/2/88
Ostrove, Nancy, Ph.D.	Director, Risk Communication, Office of Planning	OC	DC/MD	1989-2011	Operations	Consumer Studies Drug Advertising Health Literacy Labeling Social Science Risk Assessment	6/14/2013
Ottes, Ronald T.	Director, Office of Regional Operations	ORA	DENVER	1957-1985	Enforcement	Consumer Product Safety Field Work Organization & Reorganization	5/16/1986
Parfitt, Charles H.	Senior Scientific Coordinator, Division of Field Science	ORA		1971-2004	Enforcement	Consumer Product Safety Environmental Health Food Safety Management & Budget Pesticides	1/5/2006
Pauli, George	Associate Director for Science & Policy, Office of Food Additive Safety	CFSAN	DC/MD	1977-2006	Foods	Biotechnology Carcinogens Color Additives Food Additives Research & Instrumentation Risk Assessment Pesticides	7/2/2004
Pharmacologists Fitzhugh, O., Garth Laug, Edwin P. Vos, Bert J. Woodard, Geoffrey		CDER	DC/MD		Drugs	Contamination Elixir Sulfanilamide Food Additives Pesticides Radiation Research & Instrumentation Toxicology	6/20/1980
Pierce, Gary	Regional Food and Drug Director, Southwest Region, Dallas, TX	ORA	DALLAS	1972-	Enforcement	Antibiotics Consumer Product Safety Criminal Investigations Field Work Narcotics Research & Instrumentation	5/8/2003
Pilot, Larry	Device Regulatory Program	CDRH	DC/MD	1969-1979	Medical Devices	Cardiac Devices Infant Formula Legislation Reproductive Health Organization & Reorganization	12/21/2004
Pitts, Matthew	Milk Specialist	ORA	OHIO		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; Community Based Testing Facility (CBTF); COVID-19; deployment; Hurricane Katrina; Personal Protective Equipment (PPE); Nasal Swabs; Safety Officer; testing; US Public Health Service	6/10/2021
Porter, Robert G. - See also Scientists I	Planning Officer, Region VIII, Denver, CO	ORA	DENVER	1942-1977	Enforcement	Court Work Inspections Training & Recruitment Planning	10/19/1981
Pumpian, Paul A.	Director, Office of Legislative and Governmental Affairs	OPPLA	DC/MD	1966-1969	Legislative Affairs	Congressional Affairs International Affairs Narcotics Organization & Reorganization Pharmacy	1/22/1996
Rados, William R. - See also NLEA	Director, Website Management Staff, Office of Public Affairs	OEA	DC/MD	1977-2006	External Affairs	Communications Consumer Education Food Labeling Press Relations Veterinary Medicine	6/13/2006
Ralston, Deborah D.	Director, Office of Regional Operations	ORA	DC/MD	1972-2008	Enforcement	Biologics Compliance Filth Inspections Training & Recruitment Mammography Press Relations	10/21/2008
Ramsey, Lessel L. - See also Scientists II	Deputy Director, Office of Compliance, Bureau of Foods	CFSAN	DC/MD	1942-1973	Foods	Biologics Carcinogens Environmental Health Food Additives Pesticides Research & Instrumentation	2/1/1982
Rankin, Winton B. (1)	Special Assistant to the Assistant Secretary for Health and Scientific Affairs, Health, Education and Welfare	HEW	DC/MD	1939-1969	Department	Appropriations Consumer Education Food, Drug, & Cosmetic Act Inspections Training & Recruitment Pesticides Tobacco Public Health Service	7/31/1973
Rankin, Winton B. (2)	Special Assistant to the Assistant Secretary for Health and Scientific Affairs, Health, Education and Welfare	HEW	DC/MD	1939-1969	Department	1962 Drug Amendments Citizens Advisory Carcinogens Committees	2/1/1974
Rankin, Winton B. (3)	Special Assistant to the Assistant Secretary for Health and Scientific Affairs, Health, Education and Welfare	HEW	DC/MD	1939-1969	Department	Carcinogens Drug Investigations Organization & Reorganization Recalls Seafood Inspection	9/30/1980
Rayfield, Allan E.	Director, Bureau of Regulatory Compliance	ORA	DC/MD	1935-1965	Enforcement	Carinogens Drug Review Filth Food Additives Inspections Organization & Reorganization Program Planning Training & Recruitment	5/1/1979
Retzlaff, Allen T. (not an interview)	Director, Buffalo District	ORA	BUFFALO		Enforcement	Field Work Case Work	1/1/1982
Richardson, Mary-Margaret	Public Affairs Officer, St. Louis Branch	ORA	ST. LOUIS	1965-2000	Enforcement; External Affairs	Communications Consumer Affairs Inspections Press Relations Risk Assessment Training & Recruitment	3/6/2000
Ritz, James	Compliance Operations Specialist, Office of the Associate Commissioner for Regulatory Affairs	ORA	DC/MD	1976-1999	Enforcement	Criminal Investigations Generic Drugs	5/9/2001
Roberts, Henry P.	Director, Minneapolis District	ORA	MINNEAPOLIS	1951-1983	Enforcement	Cancer Fraud Field Work Organization & Reorganization Undercover Operations	6/20/2006
Roe, Robert S. - See also Scientists I and Scientists II	Director, Bureau of Scientific Standards and Evaluation		DC/MD	1925-1967		Anticommunism Chemotherapy Citizens Advisory Committees Imports Organization & Reorganization Pesticides Radiation	2/7/1982
Roh, Mark	Regional Food and Drug Director, Pacific Region, Oakland, CA	ORA	OAKLAND	1978-	Enforcement	AIDS/HIV Biologics Device Manufacturing Food Safety Industry Relations Legislation User Fees Public Health Service	9/16/2011
Ronk, Richard J.	Deputy Director, Center for Food Safety and Applied Nutrition	CFSAN	DC/MD	1961-1994	Foods	Color Additives Compliance Drug Investigations Field Work Food Additives Irradiation Nutritional Labeling Risk Assessment	5/10/1995
Ross, Nancy - See Scientists I
Ruby, Richard	Supervisory Microbiologist	NCTR	ARKANSAS		Toxicology	Cardiac Devices Enforcement Field Work Laboratory Research	5/23/2012
Rueter, Fred G.	Engineering Director	CDRH	DC/MD	1960-19994	Medical Devices	Mammography Nuclear Weapons Radiation Research & Instrumentation Tomography X-rays	1/14/1997
Rulis, Alan	Assistant to the Director for Special Projects, CFSAN	CFSAN	DC/MD	1977-2006	Foods	food additives color additives artificial sweeteners; GRAS margin of safety threshold of regulation Constituents Policy	8/14/2008
Salmon, Garett D.	Research Center Director, Total Diet Research Center and Animal Drug Research Center, Kansas City District	ORA	KANSAS CITY	1961-1999	Enforcement	Field Work Imports Information Technology Research & Instrumentation Pesticides Three Mile Island	8/30/2013
Sanchez, Carol	Director, Investigations Branch, New Orleans District Office, Temporarily Relocated to Nashville, TN	ORA	NEW ORLEANS	1974-	Emergency Response	Field Work Hurricane Katrina Natural Disasters	9/12/2007
Sano, Harold	Regulatory Project Manager	CDER	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Administration for Strategic Preparedness and Response (ASPR); Commissioned Corps Headquarters (CCHQ); COVID-19; FEMA; hospital; hurricane; mass vaccinations; Moderna vaccine; Pfizer vaccine; pharmacist; US Public Health Service; White River, AZ	4/23/2021
Sauer, Robert W.	Director, Office of Management & Communications	CVM	DC/MD	1961-2002	Veterinary Medicine	Freedom of Information Generic Drug Scandal Medical Devices Management & Budget Organization & Reorganization Planning Radiation	3/6/2001
Scarborough, Ph.D., F. Edward- See NLEA	U.S. Manager for Codex, United States Department of Agriculture (USDA), Food Safety and Inspection Service	USDA	DC/MD		Foods	Consumer Education Food Labeling Nutritional Facts	1/31/2003
Scharmann, John	Director, Denver District	ORA	DENVER	1959-	Enforcement	Dietary Supplements Field Work Medical Devices OTC Drug Review	6/17/2003
Schiffman, Clarence D. (joint interview with McManus)	Chemist, Atlanta District	ORA	ATLANTA	1929-1966	Enforcement	Field Work Fraud (legal standard) Inspections Training & Recruitment	5/10/1968
Schmidt, Alexander M.	Commissioner, Food and Drug Administration	OC	DC/MD	1973-1976	Agency-wide	Advisory Committees Clinical Trials Department Relations Dietary Supplements Drug Efficacy Study Management & Budget Policy	3/8-9/1985
Schoonover, Stuart E.	Industry Relations Officer, New York District	ORA	NEW YORK	1929-1969	Enforcement	Food Adulteration Drug Control Imports Industry Relations Inspections Labeling Training & Recruitment	5/3/1982
Schroeder, Leroy W.*	Supervisory Chemist	CDRH	DC/MD		Medical Devices	Breast Implants Genetics Legislation Organization & Reorganization Quackery Radiation Scientific Standards User Fees	2/21/2006
Schultz, Daniel G.	Director, Center for Devices and Radiological Health	CDRH	DC/MD	1994-2009	Medical Devices	Cardiac Devices Dialysis Mammography Public Health Service Radiology User Fees	10/30/2009
Scientists I Eisenberg, William V. Garfield, Fredrick Gough, Terrance Janssen, Wallace Kelly, Elizabeth Lofsvold, Fred MacFadyen, Richard Porter, Robert G. Roe, Robert S. Ross, Nancy Slocum, Glenn G. Young, James Harvey			DC/MD		Drugs Foods Toxicology	Congressional Affairs Drug Standards Enforcement Inspections Food Additives Microbiology Organization & Reorganization Research & Instrumentation	6/29/1978
Scientists II Fischbach, Henry Kline, Oral Lee Laug, Edwing Lofsvold, Fred L. Ramsey. LL. Roe, Robert S. Slocum, Glenn G. Vos, Bert J.			DC/MD		Drugs Foods Dietary Supplements	Contamination Dietary Supplements & Vitamins Filth Research & Instrumentation Seafood	12/7/1979
Sedgwick, Charles (Bill) W.	Director, Kansas City District	ORA	KANSAS CITY	1964-2005	Enforcement	Biologics Consumer Affairs Field Work	6/21/2006
Shaffer, Kelli St. Laurent, Daniel	Program Coordinator Program Coordinator	CDER CTP	DC/MD		Disaster Response; COVID-19 Public Health Emergency	Centers for Disease Control and Prevention (CDC); Commissioned Corps; COVID-19; COVID-19 Response Assistance Field Team (CRAFT); deployment; Health Resources and Services Administration (HRSA); Office of the Assistant Secretary for Preparedness & Response (ASPR); subject matter experts (SMEs); testing; virtual deployment	5/17/2021
Shane, Clifford G.	Director, Region VII, Kansas City	ORA	KANSAS CITY	1955-	Enforcement	Cancer Fraud Field Work Filth Inspections	4/23/1980
Sheppard, Audrey	Director, Office of Women's Health (Acting)	OC	DC/MD	1996-1999	Women's Health	Stakeholder Engagement Gender Differences in Health Mammography Quality Standards Act Silicone Breast Implants	8/17/2019
Sherman, Roland D.	Investigator, Chicago District	ORA	CHICAGO	1935-1978	Enforcement	Cancer Fraud Elixir Sulfanilamide Field Work Inspections	7/4/1978
Shroff, Arvin	Deputy Director, Office of Enforcement	ORA	DC/MD	1974-2000	Enforcement	Compliance Generic Drug Scandal Policy Research & Instrumentation	7/18/2000
Shumate, Mervin	Director, Office of Enforcement	ORA	DC/MD	1955-1986	Enforcement	Carcinogens Drug Efficacy Study Field Work Filth Mental Health Narcotics Organization & Reorganization OTC Drug Review Reproductive Health	3/11/1987
Silver, Kenneth A.	Assistant Regional Food and Drug Director for Intergovernmental Affairs, New York Region	ORA	NEW YORK	1967-1989	Enforcement	Field Work Inspections	3/11/1999
Silverglade, Bruce - See NLEA	Legal Director, Center for Science and the Public Interest (CSPI)	NON-FDA	DC/MD		Legal Affairs	Consumer Education Food Labeling Nutritional Facts	1/31/2003
Simmons, John E.	Director, Division of Pre-Marketing Assessment and Manufacturing Science, Office of New Drug Quality Assessment.	CDER	DC/MD	1984-2006	Drugs	Adverse Events Clinical Trials Drug Review Generic Drugs Minority Health Orphan Drugs User Fees	6/6/2006
Sink, Beulah	Executive Officer, Bureau of Medicine	CDER	DC/MD	1961-1986	Drugs	Communications External Affairs Organization & Reorganization Press Relations Veterinary Medicine	5/25/2000
Slocum, Glenn - See Scientists I and Scientists II	Director, Division of Microbiology	NCTR	ARKANSAS		Toxicology	Congressional Affairs Drug Standards Enforcement Inspections Food Additives Microbiology Organization & Reorganization Research & Instrumentation	6/29/1978
Smith, E. Pitt	Director, Buffalo District	ORA	BUFFALO	1956-1997	Enforcement	Animal Drugs Cancer Fraud Carcinogens Filth Imports Inspections Pesticides Training & Recruitment Undercover Operations	6/3/1997
Smith, Ralph - See Administrators, FDA	Acting Director, Bureau of Medicine	CDER	DC/MD		Drugs	1962 Drug Amendments Citizens Advisory Committees Field Work Food Additives Food Standards	6/30/1978
Sonosky, Jerome N.	Lawyer, Hogan & Hartson	NON-FDA	DC/MD		Legal Affairs	1962 Drug Amendments	2/28/1974
Stanfill, Robert C.	Director, Philadelphia District	ORA	PHILADELPHIA	1927-1961	Enforcement	Field Work Inspections Training & Recruitment	9/12/1981
Steele, Edward	Director of the Division of Special Programs	CFSAN	DC/MD	1963?-	Foods	Carcinogens Compliance Food Additives Food Safety Organization & Reorganization	5/23/2001
Stephens, Malcolm R.	Associate Commissioner for Regulation	ORA	DC/MD	1930-1965	Enforcement	Citizens Advisory Committees Congressional Affairs Consumer Education Food, Drug, & Cosmetic Act Field Work Fraud Cases Industry Relations Inspections Organization & Reorganization Regulatory Affairs Training & Recruitment	12/4/1984
Sterner, F. Edward	Regional Veterinarian	ORA	DC/MD	1965-1989	Enforcement; Veterinary Medicine	Animal Drugs Contamination Medicated Feed Pesticides Toxicology Veterinary Medicine	5/7/1990
Suydam, Linda A.	Senior Associate Commissioner for Communications & Constituent Relations	OEA	DC/MD	1978-1995; 1998-2002	External Affairs	Legislation Medical Devices Generic Drug Scandal Organization & Reorganization Orphan Drugs Reproductive Health Tobacco User Fees	7/24/2002
Swanson, James W.	Regional Food and Drug Director, Region X, Seattle, WA	ORA	SEATTLE	1955-1987	Enforcement	Field Work Inspections Organization & Reorganization	6/21/1988
Taylor, Christine - See NLEA	Director, Office of Nutritional Products Labeling and Dietary Supplements	CFSAN	DC/MD		Foods	Consumer Education Food Labeling Nutritional Facts	1/31/2003
Taylor, John M.	Associate Commissioner for Regulatory Affairs	ORA	DC/MD	1959-1991	Enforcement	Equal Employment Opportunity Field Work Regulatory Affairs Inspector General	12/9/1993
Taylor, Michael R. - See also NLEA	Deputy Commissioner for Policy	OPPLA	DC/MD	1991-1994	Policy; Operations	Baby Food Color Additives Field Work Infant Formula Inspections	1/31/2003
Temple, Robert (joint informal interview with O'Neill)						Clinical Trials	5/27/2011
Thomas, Mathew	Director, FDA India Office, 2015-2017; Pharmacologist/Senior Advisor for Policy; Supervisory Pharmacologist/Division Director; Supervisory Consumer Safety Officer/Branch Chief; Health Science Administrator	CDER; OC; OTP; OIP	NEW DELHI; DC/MD	1989-2023	Drugs; Orphan Products; Tobacco Products; Generic Drugs	Scientific Investigations; Foreign Offices; India; Inspections; Clinical Trials; Orphan Products	6/13/2023
Thornburg, Tyler	Director, New Orleans District Office, Temporarily Relocated to Nashville, TN	ORA	NEW ORLEANS	1972-	Emergency Response	Field Work Hurricane Katrina Natural Disasters	9/1//2007
Tidmore, James L.	Director, Office of Facilities, Acquisition, and Central Services in the Office of Management and Systems.	OM	DC/MD	1974-	Operations	Grants & Contracts Information Technology Organization & Reorganization Orphan Drugs	3/20/2003
Trepagnier, Tim ("Hurricane Katrina")	Legal Instruments Examiner, New Orleans District Office, Temporarily Relocated to Nashville, TN	ORA	NEW ORLEANS	1977-	Emergency Response	Field Work Hurricane Katrina Natural Disasters	9/11/2007
Trujillo, Adam J.	Deputy Director, Office of Regional Operations	ORA		1960-1993	Enforcement	Criminal Investigations Equal Employment Opportunity Field Work Generic Drugs Imports Inspections Legislation Medical Devices	3/16/1995 & 8/3/1995
Tucker, Robert A.	Director, State Program Coordination Branch, Division of Federal-State Relations, Office of Regional Operations	ORA	DENVER	1962-1992	Enforcement	Citizens Advisory Committees Field Work	11/6/1992
Tugwell, Rexford Guy	Assistant Secretary of Agriculture	USDA	DC/MD	1933-?	Legal Affairs; Department	American Chamber of Horrors Consumer Affairs Contamination Drug Advertising Food, Drug, & Cosmetic Act Legislation Patent Medicines Pesticide Toxicology	6/7/1968
Uhl, Kathleen	Assistant Commissioner of Women's Health	OC	DC/MD	2006-2009	Women's Health; Generic Drugs; Pharmacology	generic drugs clinical pharmacology user fees biosimilars	8/26/2019
Urban, Marie A.	Director, Office of Executive Secretariat	HEW	DC/MD	1972-2004	Department	Antibiotics Biotechnology Compliance Dietary Supplements Good Manufacturing Practices Slaughterhouse Inspections Tissue Residues	9/30/2004
VanHouweling, C.D.	Director, Bureau of Veterinary Medicine	CVM	DC/MD	1967-1979	Veterinary Medicine	Animal Drugs Carcinogens Congressional Affairs Medicated Feed Good Manufacturing Practices Veterinary Medicine	6/18/1990
Verni, Frank Nasirah, Malcolm Anyanwu, Chiemena	Regulatory Officer Regulatory Officer, BIMO International Policy Analyst	CDER CBER CFSAN	DO-NYK DC/MD DC/MD		Disaster Response; COVID-19 Public Health Emergency	Commissioned Corps; Community-Based Testing Site (CBTS); COVID-19; deployment; Diamond Princess; Long-Term Care Facilities (LTCFs); nursing homes; quarantine; repatriation; Services Access Team (SAT); Wuhan, China	4/19/2021
Villforth, John C.	Director, Bureau Radiological Health	CDRH	DC/MD	1961-1990	Radiological Health	Environmental Health Legislation Medical Devices Microwaves Nuclear Weapons Radiation Three Mile Island Toxicology X-rays	5/1/1997
Vince, Gerald E.	Director, Office of Regional Operations	ORA		1960-1998	Enforcement	Carcinogens Compliance Exports Good Manufacturing Practices Imports International Affairs Legislation Medical Devices Mutual Recognition Agreement User Fees	12/2/1998
von Eschenbach, Andrew C., M.D.	Commissioner, Food and Drug Administration	OC	DC/MD	2006-2009	Agency-wide	Bioterrorism Cancer Clinical Trials Generic Drugs International Affairs Management & Budget User Fees	9/15/2013
Vos, Bert J. - See Pharmacologists and Scientists !!	Acting Director, Division of Pathology	CDER	DC/MD		Drugs	Carcinogens Contamination Dietary Supplements Elixir Sulfanilamide Food Additives Pesticides Radiation Research & Instrumentation Toxicology	6/20/1980
Voth, Menno D.	Laboratory Director, Minneapolis District	ORA	MINNEAPOLIS	1937-1967	Enforcement	Field Work Research & Instrumentation Seafood Inspection	5/25/1983
Warden, L. Lawrence	Food and Drug Officer, Los Angeles District	ORA	LOS ANGELES	1936-1968	Enforcement	Elixir Sulfanilamide Fertility/Sterility Field Work Fraud Inspections	2/3/1978
Weilerstein, Ralph W.	Medical Officer, San Francisco District	ORA	SAN FRANCISCO	1938-1970	Enforcement	Court Work Field Work Fraud Inspections	10/12/1978
Weiss, Louis C.	Regional Food and Drug Director, Region VI, Dallas, TX	ORA	DALLAS	1939-1972	Enforcement	Field Work Inspections Pesticides Research & Instrumentation	1/25/1981
Weitzman, Irving	Special Assistant to Director, Division of Field Investigations	ORA	OAKLAND	1961-2003	Enforcement	Criminal Investigations Consumer Affairs Counterterrorism Drug Control Emergency Operations Field Work Freedom of Information Inspections International Affairs Tampering	12/10/2002
Weixel, James	Consumer Safety Officer, Office of Health Affairs	ORA	PHILADELPHIA DC/MD	1964-1996	External Affairs	AIDS/HIV Alternative Therapy Clinical Trials Planning Organization & Reorganization Stakeholder Engagement User Fees	8/11/1993
Wekell, Marleen M., PhD	Director, Office of Applied Research and Safety Assessment	CFSAN	DC/MD	1982-2010	Toxicology	Criminal Investigations Discrimination Nanotechnology Patents Organization & Reorganization Research & Instrumentation Seafood	11/9/2011
Werble, Wallace	Founder of The Food, Drug, and Cosmetic (F-D-C) Reports	NON-FDA	DC/MD	N/A		Anticommunism 1962 Drug Amendments Citizens Advisory Committees Congressional Affairs Drug Advertising Industry Relations Patent Medicines Recalls	7/28/1969
Wetherell, Robert C.	Director, Northeast Technical Services Unit, Davisville, RI	ORA	NORTHEAST	1963-1992	Enforcement	Citizens Advisory Committees Congressional Affairs Infant Formula Organization & Reorganization	9/15/1986
White, Philip B.	Director, Office of Standards & Regulations	CDRH	DC/MD	1961-1994	Medical Devices	Adverse Events Counterfeit Drugs Field Work Inspections Medical Devices Organization & Reorganization OTC Drugs	6/15/1998
Wilkens, Edward	Director of Product Surveillance and Approval, New Jersey District	ORA	NEW JERSEY	1957-2004	Enforcement	Agriculture Canned Foods Field Work Inspections Narcotics Undercover Operations	4/20/2004
Wilkinson, David	Regulatory Officer	ORA	BOCA RATON, FL		Disaster Response; COVID-19 Public Health Emergency	COVID-19; emergency response; FDA Commissioned Officers Network (FCON); Florida; Indian Health Service (IHS); Public Health Service (PHS); safety officer; community-based testing; biomedical engineering; medical devices	4/26/2021
Williams, Richard E.	Director, Baltimore District	ORA	BALTIMORE	1939-1962	Enforcement	Adulterated Foods Field Work Good Manufacturing Practices Inspections	3/20/1989
Wilms, Heinz G.	Director, Division of Federal State Relations, Office of Regional Operations	ORA	DC/MD	1971-1994	Enforcement	Environmental Health Health Fraud Legislation Medical Devices Radiation	12/7/1994
Wojtowicz, Edward	Analytical Chemist, Buffalo District	ORA	BUFFALO	1962-1997	Enforcement	Carcinogens Consumer Affairs FieldWork Inspections Narcotics Research & Instrumentation Steroids	6/3/1997
Wood, Charles A.	Resident Inspector, Portland, ME	ORA	PORTLAND	1919-1953	Enforcement	Contamination Inspections Training & Recruitment Toxicology	6/9/1980
Wood, Gordon R.	Director, Los Angeles District	ORA	LOS ANGELES	1931-1969	Enforcement	Consumer Affairs Drug Control Field Work Food, Drug, & Cosmetic Act Fraud Cases Health Food Fraud Inspections Natural Disasters Organization & Reorganization Training & Recruitment	2/2/1978
Wood, Susan	Assistant Commissioner for Women's Health	OC	DC/MD	2000-2005	Women's Health	emergency contraception hormone therapy Mammography Quality Standards Act silicone breast implants	8/23/2019
Woodard, Geoffrey - See Pharmacologists	Pharmacologist, Division of Pharmacology	CDER	DC/MD		Drugs	Carcinogens Contamination Dietary Supplements Elixir Sulfanilamide Food Additives Pesticides Radiation Research & Instrumentation Toxicology	6/20/1980
Wulfsberg, Einar T.	Food and Drug Officer, Division of Case Control	OC	DC/MD	1939-1967		Carcinogens Food Additives Fluoride	6/17/1982
Yakowitz, Morris	Director, Division of Case Guidance		DC/MD	1931-1966			4/19/1979
Young, Frank E.	Commissioner, Food and Drug Administration	OC	DC/MD	1984-1989	Agency-wide	Biotechnology Breast Implants Carcinogens Clinical Trials Congressional Affairs Drug Review Food Additives Food Labeling Generic Drug Scandal Medical Devices Orphan Drugs Tobacco User Fees	12/8/2000
Zaic, John	Deputy Director, International Affairs Office	OIP	DC/MD	1939-1980	International Programs	Field Work Imports Inspections International Affairs	12/4/1986