A GUIDE TO RESOURCES
ON THE HISTORY OF THE
FOOD AND DRUG ADMINISTRATION
1995
Food and Drug Administration History Office A GUIDE TO RESOURCES
ON THE HISTORY OF THE
FOOD AND DRUG ADMINISTRATION
1995
Food and Drug Administration History Office HFC-24, Room 13.. 51 5600 Fishers Lane Rockville, Maryland 20857
(301) 443~367 CONTENTS
Background: FDA' s Origins and Functions ...... 1 Selected Federal Food, Drug, Cosmetic, and Device Laws ...... 2
Researching the History of FDA ...... 2 Published Primary and Secondary Sources on FDA History ...... 2
Part I: Primary Sources ...... 2 General Sources ...... 2 Legal Sources ...... 3 Sources on Regulations and Enforcement ...... 3 Sources on Science and Research ...... 4
Part II: Secondary Sources ...... 4 General Sources ...... 4 Sources on Drug, Biologics, and Cosmetics Regulation ...... 5 Sources on Food, Device, and Veterinary Medicine Regulation ...... 6
Unpublished Sources on FDA History ...... '...... 7 Non-FDA Records ...... 7 Case Files ...... 8 AF Files and Decimal Files ...... 8 New Drug Applications ...... 8 Dockets Management Branch Files ...... 9 Audio-Visual Resources ...... 9
The FDA History Office ...... 10 Evolution ...... : ...... 10 Functions ...... 11 The Oral History Program ...... 11 The Museum Collection ...... 12 Staff ...... 13 This guide is designed to familiarize FDA staff, other government employees, historians, the press, regulated in dustry, students, 11nd anyone else interested in regulatory history with the van'ous resources on the history of the FDA. Included are both core sources useful for specific inquiries into the agency's p11St and infof'mllhon for those pursuing extensive historical research on the FDA. In addition, the guide discusses the structure, functions, and some of the programs of the FDA History Office. The office hllI 11 wide range offunctions 11nd offers 1111rious types of assistance to staff 11nd outsiders, as reflected in some of the programs and 11Ctivities menh'oned Ill the end of this guide. The FDA is the oldest federal agency that has III its principal purpose the protection of consumer health; this guide will help those who want to le11m more about the evolution of this agency.
BACKGROUND: FDA 'S ORIGINS drug, sulfanilamidc. So-called Elixir Sulfanilamide em AND FUNCTIONS ployed an untested solvent for the drug, dicthylene glycol, and eventually it killed over a hundred people, most of The origins of the Food and Drug Administration can whom were children. The 1938 Food, Drug, and Cosmetic be traced back to 1862, when President Lincoln appointed Act, which remains the basic law we have today, fearurcd chemist Charles M. Wetherill to head the Chemical Di many provisions lacking in the 1906 act. For example, it vision in the new U. S. Department of Agriculture. In mandated that all new drugs be proved safe before mar the following decade Wctherill's successor as chief chemist keting, therapeutic devices and cosmetics become subject of the USDA, Peter Collier, began working on the ubiq to regulation, and standards of identity and quality be uitous problem of food adulteration. Harvey W. Wiley instiruted for foods. The law also formalized FDA's abil replaced Collier in 1883, leading the division as it grew ity to conduct factory inspections. into the Bureau of Chemistry in 1901. The bureau was charged to enforce the first comprehensive federal starute of its kind, the Federal Food and Drugs Act, when that law was passed in 1906.
In 1927 Co~ authorized the formation of the Food, Drug, and Insecticide Administration from the regulatory wing of the Bureau of Chemistry; the name of the agency was shonened to the Food and Drug Administration in 1930. FDA left the Department of Agriculrure in 1940 for the Federal Security Agency, which was created a year earlier. In 1953 FDA joined the Department of Health, Education, and Welfare after Congr~ established that department to assume certain functions of FSA. In 1968 the agency became part of the Public Health Service within HEW. When the education function was removed from HEW to create a separate department, HEW became the Department of Health and Human Services in 1980. FDA's responsibilities derive from starutcs that date back to the early twentieth cenrury. Harvey Wiley fought long and hard to unify disparate interest groups behind a federal law to deal with serious problems in the food and drug supply. Through Wiley's crusading, the sup pon of the General Federation of Women's Cubs, the work of muckraking journalists, the cffons of state and local food and drug officials, cooperation from the Ameri can Medical Association and the American Pharmaceu tical Association, and the impact of Upton Sinclair's The jungle, a novel depicting the filth of the meat packing Harrie} .W;ky, in tcp "'11 tmtl klils, on his UJaJ. lo mde one of industry. Cong~ approved one of the landmarks of his t111my speeches for "ferkrrt/ footl ""ii ti!11gs lllw. Progressive era legislation in 1906, the Food and Drugs Act. Among other provisions, this law charged the Bureau Over the following decades numerous amendments and of Chemistry to control-albeit to a lesser extent than other acts broadened FDA's responsibilities considerably. Wiley and others had hoped-adulterated and mis These include a mandate for agency testing ofinsulin and branded drugs and food in interstate commerce. antibiotics; regulation of chemical pesticides and food and color additives; distinction between prescription and non FDA initiated a movement to replace the problemat prescription medications; regulation of drug efficacy; ical aspects of the 1906 act during the nascent New Deal. ensuring of good manufacturing practices; control of pre Again, the support of women's groups, journalists, and scription drug advertising; regulation of thcnpcutic agents others was imponant to the final passage of a bill, as was of biological origin; and oversight of nutrition labeling. the repcramion from a toxic preparation of the wonder The realities of enforcing such broad starutcs requites
1 FD.A's interaction with a variety of politiw, economic, PUBLISHED PRIMARY AND SECONDARY and social interests. Today, as in the past, FD.A strives SOURCES ON FDA HISTORY above all else to safeguard the health and well being of the .American people. PART I: PRIMARY SOURCES SELECTED FEDER.AL FOOD, DRUG, GenertJI Sources COSMETIC, AND DEVICE LAWS The Food and Drug Refliew began in 1917 as a means Drug hnponation Act ...... June 26, 1848 of communicating infonnation privately to state food and Tea hnponation Act ...... Maleh 3. 1883 drug officials to assist them in helping enforce the 1906 Food and Drug hnponatioo Act ...... August 30, 1890 federal act. Soon the Review became a vehicle for FDA Tea hnponatioo Act ...... March 2, 1897 Food hnponation Act ...... Man:h l , 1899 headquarters to inform field offices about relevant pub Biologics Conaol Act ...... July l , 1902 lications, speeches by FD.A sta.ff, personnel changes in Food and Drugs Act ...... June 30, 1906 the agency, the status oflegislation, enforcement activi Meat Inspection Act ...... June 30, 1906 ties in other field offices, and so on. In many ways the Sherley Amendment ...... August 23, 1912 Re11iew is a son of diary of activities at FD.A, issued Federal Trade Cornmimon Act ...... September 26, 1914 Harrison Nan:oc:ic Act ...... December 17, 1914 monthly with illustrations and indexed annually (except Food, Drug. and Uismetic Act ...... June 2), 1938 the last three volumes). A few research libraries have pur Miller Amendment ...... June 24, 1948 chased microfilm copies of the Review, which ceased pub Dudwn-Humptuey Amendment ...... October 26, 19H lication in 1966. Microfilms arc still available through Factory Inspection Amendment ...... August 7, 19H the Library of Congr~ . The cumulatively indexed FDA Miller Pesticides Amendment ...... July 22, 19~4 Food Additives Amendment ...... September 6, 19)8 Papers-which changed its name to FDA Com11mer in Pesticide Chemicals Amendment ...... June 29. 1960 1973-succccdcd the Re11iew, but its thrust was very Color AdditiYC Amendment ...... July 12, 1960 different than the Review, emphasizing articles of interest Kefauvcr-IWris Drug Amendments ...... October 10, 1962 to consumers, as the newer title suggests, and including Drug Abuse Cooaol Amendments ...... July l~. 196) the official summaries of agency enforcement activities Child Prottctioo Au ...... Na.ember 3. 1966 Viwnin-Mineral Amendments ...... April 22, 1976 (sec below). FDA Today , a monthly employee newslet Medical Device Amendments ...... May 28, 1976 ter with illustrations that began in 1974 and is still pub Saccharin Study and Labeling Act ...... Na.ember 23, 1977 lished, probably was closer in scope to the Rniew, but Orphan Drug Act ...... Januaiy 4, 1983 it was much less comprehensive than the Re11iew. Sal-e Medical Devices Act ...... October 27. 1990 Nutrition Labeling and Education Act ...... November 8, 1990
RESEARCHING THE HISTORY OF FDA• While rcseatth is a primary function of the ID.A History Office, we also tty to &cilitatc srudies by historians and others. Often a person needs merely a rdCrcncc or two to investigate a particular question on the history of regula tion and ID.A, and History Office staff will run a quick check of our internal reference sources to mist with such a query. However, some individuals have a much broader interest in ID.A history, requiring more extensive rcscarch and resulting in lengthy articles and books. Some scholais devote entire catteis to the srudy of FD.A and related M tory. Many of the worlcs listed under the ''Sdcctcd Soun::es'' below arc grounded in large part on FD.A records. The re sources available for the study of this subject arc extensive, and here we can indicate only unc of the more basic places to begin. The majority of the published secondary sources should be easily obtainabk at most univc.rsity libraries, but many of the published primary sources would more likely be found in law libraries, general university libraries, or other facilities designated as government document deposi tory libraries. Ifuncertain, check with a reference librarian. Locltions of the unpublished records arc mentioned below.
• Para of this .section att adapted from James Haney Young and Wallace Janssen. " Food and Drue Admi.nisuatioo: Sources of Historical lnformacioo," unpublished 29·Pa&e typeSCript, tile$, FDA History OffKe; xe also Paul B Dunbu's Introduction co Fetlnrtl Footl, Dnlg •tiComum A~I: Atl-h'llliH An inspeclor tlriJls iflto 11 conllllner of Repon1, 1907-1949 (ciced in die bibliography below). ftoze11 eus lo colkcl " s11mple.
2 The annual reports of the Bureau of Chemistry and the Sources on Regu/alions and Enforcement FDA are another useful source on agency activities. Earlier FDA has long pursued a policy of enforcing food and reports of the Chief Chemist of the Chemical Division and drug laws that relics on full and frequent notification of the Division of Chemistry were included in the annual re regulated industry and others about how statutes and regu pon of the Sccrctary of Agriculture. The modem annual lations affect them. On 17 October 1906 the U. S. Depart· reports of the agency have been collected and published ment of Agriculmre issued "Rules and Regulations for the in two volumes: Federal Food, Drug and Cosmelk Law: Enforcement of the Food and Drugs Act'' as Circular No. AdministralWe Reports, 1907-1949 (Chicago: C.ommerce 21 from the Office of the Secretary. The forty rules and Oearing House, 1951), and Food and Drug Administra regulations published at that time underwent several revi tion, Annwl Reports, 1950-1974 (Washington: Govern sions up to the time of the 1938 act; however, each of these ment Printing Office, [1974)). revisions continued to be published as Circular No. 21. The first volume has a fairly shon index, while the lat Food Inspections Decisions (FIDs) were another pub ter collection has a separate index, compiled by Edward lished venue for notification of changes in regulations. M. Shoemaker and published in 1983 by the American These were formal statements issued over the signature of lnstimte of the History of Pharmacy. Madison, Wiscon the Sccrctary of Agriculture or, in some cases, over the sig sin. The reports from hcadquaners and field offices on namres of the Sccrctarics of Agriculture, Treasury, and which these annual reports are based are included in the C.Ommerce. The first thiny-nine FIDs penained to interpre decimal files in the FDA unpublished records (see below). tations of the Imponed Food Act of 1899, which the The annual reports, which ceased publication in 1979, were Bureau of Chemistry was charged to enforce. From 1906 succeeded by the Quarterly Aclivities Reports. The latter to 1934, the Bureau of Chemistry and then the FDA issued contain a straightforward factual account that includes in FID 40 through 212 to explain regulation of the 1906 act. tcmal rcoiganizations, executive personnel changes, enfo1te The agency published Service and Regulatory Announce· ment highlights and statistics, major court decisions and ments (SRAs) until shortly after the 1938 act, first as a laws, and so on. monthly and later on an irregular basis. The SRAs included One can glean the concerns and interests of regulated FIDs as well as other policy matter that did not have the indusay through the trade literature, which includes pc?· formality of FIDs, subject to prompt change if develop odicals such as Oil, Paint and Drug Reporter (founded 10 ments warranted. 1871 and continuing after 1972 as Chemical Marketing After the 1938 act, FDA issued informal opinions, Reporter), FDC Reports (1939 to the p~t), Food Chem known as Trade C.orrespondence, based on its daily cor U:al News (1959 to the present), and Drug and Cosmelk respondence with manufacturers. They contained excerpts Ind11Stty (established in 1914 as Weekly Drug Markets and from the replies to regulated companies' queries about reg continuing under the present title after 1932). The Food ulations under the act. The issues of Trade C.Oncspondence Drug Cosmelk Law joumal (1946 to the present) provides were not published, but rather were mimeographed and useful insight on FDA history from a wriety of viewpoints. distributed to the staff to maintain uniformity in policy This journal has a cumulative chronological listing of ani throughout the country. They were available for inspec cles in broad subject areas. tion in field offices and at FDA hcadquaners. The com /Aglll SotmeS plete series of Trade C.orrespondencc, which ran from 26 August 1938 to 4 April 1946, was published in Vincent ScvenI publications trace details of the evolution of food A. Kleinfeld and Charles Wesley Dunn, Federal Food, and drug legislation and how it played out in the courts. Drug, and Cosmelk Act: judicial and Administrati11e A publication of the U. S. Department of Agriculture, Record, 1938-1949 (Chicago: C.ommerce Qearing House, Mastin G. White and Otis H. Gates, Decisions of Courts c. 1949). 561-753, which is indexed. The agency's press in Cmes under the Federal Food and Drugs Act (Washing releases and talk papers present FDA's viewpoints and poli ton, D. C.: Government Printing Office, 1934), identifies cies on a wide wriety of issues; the FDA Medical library and analyzes major cases stemming from the 1906 act. An has many of these on microfilm, and a list of press release ongoing publication, Federal Food, Drug, and Cosmelk titles exists for those issued from about 1950 to 1965. The Act: judi&ial and AdministralWe Record (Chicago: C.om Office of Public Affairs has indexed the recent prm releases merce Qearing House, c. 1949-1992), asmmes a similar and talk papers. task for the 1938 act and its amendments. An FDA publi cation comprised of 34 volumes, including appendices, A The most important source to track changes in FDA reg LegislalWe History of the Federal Food, Drug, and Cos ulations, from 1936 to the present, is the annually indexed melk Act and Its Amendments, is a documentary history Federal Register, this is particularly the case after ~ of the 1938 act. It explains why the laws are couched the of the Administrative Procedure Act in 1946. The nam. way they ale. Peter Batton Hutt and Richard A. Merrill's tive preambles to final regulations in the Federal Register Food and Drug Law: Cares and Mllleria/s, 2d ed. (West can be especially useful in discerning the agency's mindset bury, N. Y.: Foundation~, 1991), isamorcrecentin behind its rulcmaking. terprcwion of the impact of court decisions on FDA An ~ntial tool for rcscarching enforcement actions policies; the authors reproduce a wriety of primary and taken by the agency a1e the Nolkes ofjudgment under secondary sources as well. the Food tmd Drugs Act and the Nolkes ofjudgment
3 under lhe Ferlmtl Food, Drug and Comutic Acl, required Adulleranls, was issued in ten parts in over 1500 pages, by provisions of the laws. These were published in groups from 1887 to 1902. Bulletin 84, on Influence of Food of fifty by the Department of Agriculture (and later by the Preser11111"'es and Arlifoi111 Colors on Digeslion and Federal Security Agency and the Dcparunent of Health, HelJ/1h, was a five-pan, 1500-pagc study from 1904 to Education and WcJ&rc) beginning in 1908. They summa 1908. Agency scientists did not publish their work in the rize the government's case against a product, including the Bulletins and Circulars exclusively. Indeed, many in the evidence of a product's adulteration or misbr.mding; often Bureau also published in the standard professional journ the notice will include a chemical analysis of the offend als of the day. But the Bulletins and Circulars arc the ing product. The Notices report the outcome of the cases most significant single source to document science and as well. research in the early history of FDA.
PART II: SECONDARY SOURCES * * The following bibliography is quite literally a list of selected sources that will be useful to anyone interested in the history of the FDA and related isrues. Most of these arc interpretive secondary sources with ample refer ences-if not bibliographies-co additional literature in the field. This should be considered merely a good start ing point to investigate the field. GenerlJ! Sounes Young, James Harvey. Pure Food: Securing lhe Federal Food and Drugs Acl of 1906. Princeton: Princeton University Press, 1989 (definitive history of this land mark Progressive era legislation, including an histori ography of the subject). The Medical Messiahs: A Social Hislory of Hellllh QU11&kery in Twenlielh-Cenltlry Ameriu. Princeton: Princeton University Press, 1967 (indicative subtitle; in cludes much on FDA). ''Food and Drug Administration.'' In Govemmenl Agencies, ed. Donald R. Whitnah, 251-57. Westport, C.Onn.: Greenwood Press, 1983 (a brief but succinct his tory of FDA, with a short bibliography). ''The Pig That Fell into the Privy: Upton Sinclair's The jungle and 1he Meat Inspection Amendmenls of1906, '' Bulletin of1he Hislory ofMedicine 59 (1985 ): 467-80 (impact of the novel and subsequent investigation on this Progressive era law). The fust 10,000 notices arc indexed, from 1908 to 1922, "From Oysters to After-Dinner Mints: The Role of the as are Notices ofJudgment 10,000 to 20,000. Thereafter, indices covered 1000 notices at a time. The indices are es Early Food and Drug Inspector," ]ourntll of1he His pecially useful in revealing recidivism. For example, the lory ofMedicine and Allied Sciences 42 ( 1987): 30-5 3 (fascinating study of the first FDA inspectors). Pabst Chemical C.Ompany, putvcyor of Pabst Oby specific drug, was cited in twenty-seven Notices ofJudgment from "Food and Drug Enforcers in the 1920s: Restraining 1915 to 1919. The published notices, which were distrib and Educating Business." Business and&onomi& His uted to government depository libraries, also provide keys lory, 2d ser., 21 (1992): 119-28 (enforcement policy un to more detailed information in the manuscript records of der the 1906 act). FDA (sec below). The separately published notices ceased Anderson, Oscar E., Jr. The Heal1h ofti Nt1h'on: H/.lrvey in 1966; thereafter they were appended to FDA Papers (and W. Wiley and 1he Fight for Pure Food. Chicago: later, FDA Consumer) in a significantly curtailed format. University of Chicago Press, 1958 (masterful biography; Sources on Science amt Reset1reh also an excellent early history of the 1906 act and the predecessor agency of FDA). The Bulletins and Circulars of the Bureau of Chemis try also arc helpful on the history of the agency; these Jackson, Charles 0. Food and Drug Legislation in 1he total hundreds of sep~te publications, from the late New Deal. Princeton: Princeton University Press, 1970 ninetccnth century origins of regulation to the 1920s. (on the formation of the 1938 Food, Drug, and C.Os Most are just a few pages each, but Bulletin 13 and 84 mctic Act). are notable exceptions. The former, on Foods and Food ••Presented in rmdom order.
4 O'Reilly,Jarncs T. Food and Drug Administration, 2d ed. 8-27. Madison, Wis. : American Institute of the History 2 voJs. Colorado Springs, Colo.: Shepard's/McGraw-Hill, of Pharmacy, 1982 (on the coming of the federal sta 1993 (this useful, comprehensive resource summarizes tute that brought vaccines, scra, and antitoxins under legal history behind a wide variety of policies). regulation). Christopher, Thomas W. "Aniclcs on Food and Sonnedcckcr, Glenn. ''Drug Standards Become Offi Drug Law." Food Drug Cosmetic liJw]ouma/13 (1958): cial.'' In The &rly Yem:r ofFederal Food mu/ Drug Con 487-98 (dated but useful bibliography drawn exclusively Jro/, 28-39. Madison, Wis.: American Institute of the from legal periodicals, arranged by subject). History of Pharmacy, 1982 (how the United States Phar macopoeia and the National Formulary became official Wiley, Harvey W. An Autobiography. Indianapolis: drug compendia under the 1906 act). Bobbs-Merrill, 1930 (an illustrated and indexed life and career of the father of FDA). Mcfadyen, Richard E. "Thalidomide in America: A Brush with Tragedy." Clio Medica 11, no. 2 (1976): 79-93 Lamb, Ruth deforest. A~ Chamber of Honvrs: (good companion piece to Young's "Sulfanilamide," The Truth llhout Food mu/ Drugs. New York: Farrar and because thalidomide had a similar impact on the pas Rinchan, 1936 (on the many short.comings of the 1906 sage of major drug regulatory legislation, the Kcfauver act, and why a new law was needed, by the Chief Educa Harris Drug Amendments of 1962). tional Officer at FDA). "&tcs Kefauver and the Drug Industry." Ph. D. diss., Brannon, Michael. "Organizing and Reorganizing Emory Univctsity, 1973 (a background for the enactment FDA." In Se11enty-Ftfth Annwersary Commemortlli11e of the drug amendments of 1962). Volume ofFood and Drug Llw, 135-73. Washington: Food and Drug I.aw Institute, 1984 (documents the Hutt, Peter Banon. "Investigations and Reports Respect myriad structural changes within the agency). ing FDA Regulation ofNew Drugs." Clinical Phllf'lnlZ colagy tlN/Therapeutics 33 (1983): 537-48, 674-87 (more FDA Comumer 15, no. 5 (1981) (this issue commem descriptive than intctprctive, this serves as an excellent orating the 75th anniversary of the 1906 act includes a refelCOCC source on the role of outsiders, such as advisory variety of historical ankles). committees, in shaping drug regulation policy of FDA, $()tll'Us on Drug, Biologics, tmtl Cosmetics Regulation from 1939 to 1983). Young, James Harvey. The Toadstool Millionaires: A Ward, Patricia Spain. "Who Will Bell the Cat?: Soda/ History of Patent Met/kines in America before Andrew C. Ivy and Krcbiozen,'' Bulletin ofthe History Federal Regu/alion. Princeton: Princeton Univctsity Press, of Medicine 58 (1984): 28-52 (history of quack cancer 1961 (the subtitle conveys the subject of this pioneering drug, Krcbiozen, and the strange story of the scientist, study). Andrew C. Ivy, who endorsed it and thus ended his "Sulfanilamide and Dicthylcne Glycol." In Chmlistry professional career). tmtl Modern Society: Historical Essays in Honor ofAaron Van Winkle, Walton, Jr. ct al. "Appraisal of New Drugs." ed. John Pawcandola and James C. Whonon, ]. Ihde, ]oumal ofthe American Medical .Association 126 (1944): 105-25. Washington, D. C.: American Chemical Soci 958-61 (significant because this is among FDA's earliest ety, 1983 (on the key event in 1937 that precipitated published policy statements on how to submit a New statutory drug safety). Drug Application). ''Federal Drug and Narcotic Legislation.'' Phtll"miley in Swann, John. "FDA and the Practice of Pharmacy: History 37 (1995): 59-67 (summarizes the principal drug Prcsciption Drug Regulation to 1951." P"'1nna&y in His laws, with references to the primary and relevant sec tory 36 (1994): 55-70 (reference to the basic drug laws ondary literature). from the 19th to mid-20th centuries, and cooperation American Health Quader:/. Princeton: Princeton Univer and conflict between organized pharmacy and FDA). sity P~. 1992 (a collection of his published essays on Blake, John B., ed. Safeguarding the Public: Historical this theme, with a new essay on AIDS quackery). Aspects of Medicinal Drug Control. Baltimore: Johns J~. Wallace. "Outline of the History of U. S. Drug Hopkins P~. 1970 (several useful papers and discus Regulation and Labeling." Food Drug Cosmetic l4w sions thereof, including th~ on 19th century drug regu ]ouma/ 36 (1981): 420-41 (a useful overview, cspccially lation, drug regulation under the 1906 act, and with respect to misbranding). regulation after 1938). Temin, Peter. Taking Your Medicine: Drug Regulation Dowling, Harry F. Medicines for Man: The De11elopment, in the Uniled Sltlles. Cambridge, ~.: Harvard Uni Regulation, anti Use ofPrescription Drugs. New York: vcmty ~. 1980 (mises many interesting issues deserv Alficd A. Knopf, 1970 (intcmalistic but very useful over ing funhcr study, but this economist's interpretations view of the subject). of regulatory history arc sometimes questionable). Marks, Harry Milton. "Ideas as Reforms: Therapeutic Kondni.tas, Ramunas. "Biologics Control Aa of 1902." Experiments and Medical Practice, 1900-1980." Ph. D. In The 1!4r/y Yetm ofFederal Food anti Drug Control, diss., Massachusetts Institute of Technology, 1987 (a
5 detailed study of clinical investigations in the U. S., Devices.'' Food Dnlg Cosme#& Law journal 44 (1989): including FDA's involvement). 99-117 (a good, succinct survey of the history of device regulation outside of quackery). Maeder, Thomas. Ad11me Re11&tions. New York: William Morrow, 1994 (good regulatory history of an early an and Peter Barton Hutt ll. ''A History of Government tibiotic, chloramphenicol, and its rare but fatal side Regulation of Adulteration and Misbranding of Food,'' effect, aplastic anemia). Food Dnlg anrJ Cosme#& L1w journal 39 (1984): 2-73 (complete overview of governmental food regulation). Taylor, Michael R. ''History of Cosmetic Color Additive Regulation: Creative Maneuvering by FDA Bodes Well Janssen, Wallace F. "Inside the Poison Squad: How Food for the Future.'' Food 'Drug Cosme Ii& Law journal 37 Additive Regulation Began" Association ofFood and (1982): 152-62 (regulation under the 1938 Act, under Dnlg Offeials Quarterly Bulletin 51, no. 2 (1987): 68-72 the Color Additives Amendment of 1960, and the (the story of Wiley's famous experiment to illustrate the 1980 listing oflcad acetate as a signal of future policy). hazards of additives using volunteer subjects).
Souues on Food, Dnice, 11nJ Veterimlry Medi&ine Levenstein, Harvey W. Revolution t:ll the Table: The Regu/lltion TransjomuJtion ofthe Americtln Diet. New York: Ox Belasco, Warren J. Appelile for Change: How the ford University Pim, 1988 (discusses the changes in Counlemllture Took on the Food Industry, 1966-1988. American caring habits as knowledge about nuuition has New York: Pantheon Books, 1989 (discusses the coun advanced over the century). tcn:ultural critique of governmental policy towards food Paradox ofPlenty: A Soda/ Hirtoty ofFating in M.oriern and food additives between the 1960s and the 1980s). Ameril:tl. New York: Oxford University~. 1993 (con Bosso, Christopher J. Pesliciries anrJ Politics: The life tinuation of previous volume beginning with the Great Cyde ofA Public Issue. Pittsburgh: University of Pitts Depression to the present) burgh P~. 1987 (good general history of pesticides Marcus, Alan I. Cancer From Beef: DES, Federal Food regulation, but contains a few errors regarding regu Reguhtion, '1nri Consumer Confoleme. Baltimore: Johns lation). Hopkins Pim, 1994 (history of diethylstilbestrol used in cattle). Whitaker, Adclyne Hiller. "A History of Federal Pesti cide Regulation in the United States to 1947." Ph.D. . ( diss., Emory University, 1974. Hochhciscr, Sheldon. "Synthetic Food C.Olors in the United Swcs: A History under Regulation.'' Ph.D. dis<>., University of Wisconsin, 1982. Soavc, Orland. "History of Veterinary Medicine in the Food and Drug Administration.'' journal ofthe Amen._ can Veterinary Medical k
7 headed the predecessor of IDA from 1883 to 1912. In AF Fik1 11tul DecimJ Fiks cluded in the Wiley Papers are several diaries and a bib The so-called AF files reveal much about FD.A's in liography of publications of the Bureau of Chemistry from teraction with the regulated industry. These include cor 1862 to 1924. The Library of Co~ also houses the col respondence between the agency and companies, as well lected papers of Wiley's wife, .Anna Kelton Wiley, which as inspection rcpons on the firm. Used together with the contains some papers of Harvey Wiley from about 1900 case files, the researcher can derive a full appreciation to 1930. for the enforcement of food and drug laws. One can trace The .American Mcdica.l .Association's Historical Health the story of a violative item beginning with FD.A's ini Fraud and .Alternative Medicine Collection is an excellent tia.l inspection of a company, to seizure of the product source of correspondence, circulars, clippings, and other in question, to final resolution of the affair in the couns. matter on the history of quackery. This collection derives The agency's decimal files include the widest ranging from the AMA' s Dcpanmcnt of Investigation and covers topics of a.11 the collections. These files, which represent most of the twentieth century, including extensive the totality of the agency's concerns, arc arranged by sub material on Harry Hoxscy, Alben Abrams, rheumatism ject; each subject is given a discrete number between 000 cures, and hundreds of quacks and quack products. The and 999. The system, which is indexed alphabetically by AMA published a very useful finding aid to the collec subject and by number, has been updated constantly tion, Anhur W. Hafner ct al., Guide lo the American through time. For example, this system assigns food soft Medical As1ocialion Hirlorical Health Fraud and Alter eners the number 489 .1, radio advcnising for cosmetics natzile Medicine Collection (Chicago: .American Medi is 580. 71, complaints from businesses about enforcement cal Association, 1992). methods is 691 whereas consumer complaints about the Researchers should be aware that the agency is bound laxness of enforcement procedures is 609. 3, counterfeit by legislative fiat not to divulge confidential informa drugs arc 500.24, cxponing of medical devices is covered tion such as uadc secrets or patient information. Accord in H0.66, regulations for pesticides in foods is 051.12 ingly, for most records under FD.A's control one muse (FDA regulations in general arc covered under 051 ), and begin by filing a freedom of information (FOi) request so on. with the agency. This is most efficiently done after con sulting with the History Office about the son of records that would most likely address the subject at hand. The FOi process must by law occur in a timely manner, but a person still should allow ample lead time so the FOi request can be processed, records can be identified and , pulled, and so on. Case Files FDA has a variety of records, but most fall within the following groups: case files, AF files, decimal files, new ,. drug applications, and the assonmcnt of records under the Dockets Management Branch. Case files document the litigation stemming from violations of food and drug legislation, from the initial complaint filed by the U. S. Att0mey through the conclusion of the case in the courts. Some files include correspondence with witnesses whom the agency sought to recruit for the trials. Sometimes FDA had an observer at trials who would correspond with hcadquancrs about the progress of the proceedings, conversations overheard, and occasionally the results of ''tailing'' a suspicious defense witness out side the courtroom. Complete transcripts of trials some times arc in the case file. However, one should be aware that the courts themselves might be a better source for transcripts and supponing documentation, especially for cases accepted on appeal by the Supreme Court. The above-mentioned Noti&e1 of]11dgment arc an important tool to be used in conjunction with the case files, since A mg ~pores 8 Olsmctic Act to prove the ,..fcty of their drugs before IDA D«hls Mimllgement Bnm&h Files could approve the product for marketing. C.Ompanies sub Many files of the Dockets Mamgcmcnt Branch of IDA mitted chemical, phannacological, and clinical evidence to overlap other record groups that have been discussed, but the agency to establish ,..fcty and-following the 1962 drug since this broad group of public records is under the amendmcnts-dlicacy of their phannattuticals. The vol jurisdiction of a single office, they will be cited here. wne of each NOA has grown over the ycais to meet the Noteworthy holdings of this office include records from dwiging Jaws and qulations, such that the earliest NDAs cvidcntiary hearings of the Administrative Law Judge; are merely a fraction of what manufu:twcrs submit today. Hearing Oerk's records; summaries of approval for new At present the total nwnbcr of NOAs is about 20,000. This animal drugs and new medical devices, including labelling group of records documents, more than any other single and environmental impact Statements; and papers ooUcction anywhere, the cvidcocc for the ~ in drug pcm.ining to citizens' petitions. Of particular interest to therapy in this century. rcsca!clicts are the m:ords of public comments on proposed Most of each NDA is confidential because of the com rulemaking, i.e., responses to proposed regulations mcrri21 information required; in addition, there are privacy published in the Federal Register, and the minutes and transcripts of advisory committee meetings (with the act conccrm that pJ:eYCOt rel~ of most of the NOA. How ever, there is still substantial so-called approvability cor exception of those ponions of meetings that are cl~ to respondence that is releasable, and since the 1970s the IDA the public). has ismed a summary basis of approval (SBA) for each Audio-Vist141 Resourees NDA, which distills the voluminous data and conclusions Researchers should also be aware of the rich collections in the application (for other product approval documents, of non-textual documentation of FDA histoty. The sec Dockets Management B120Ch Files below, or consult Natiooal An:hivcs has the most cxtcl1SM collection of prints the relevant Center). The History Office is working with and photographs of or related to IDA. Record Group 88 a distinguished committee of outside and internal experts has nearly 4,000 photographs before the 1938 act. on drug information and the history of pharmacology to Post-1938 photos number about three times that many. conduct a systematic examination of the NDAs. This cf. For example, pictures of IDA activities from 1962 to 1977, fon will identify historically significant NOAs that will be mostly from FDA Papers and FDA Consumer, total 61 permanently preserved in the National Archives, as well boxes. Fonunatdy, thett is a finding aid that identifies both as widomly selected NDAs to capture changes in drug subjects (for the first twenty-one boxes in this collection) evaluation methodology over time. and the location of pictures from individual imles of the twO publications above (for the remaining forty boxes); the cumulative indices to FDA Papen and FDA Consumer can function as de facto subject guides to these forty boxes. In addition to the material at the National Archives, the Wiley Papers at the library of C.Ongrcss include ten boxes of prints and photographs. The History Office has a sizeable collection of visuals in various media. The photographs and slides are organized by subject, covering a wide array of agency functions and relevant topics, as well as a number of group and individual poruaits. The collection of videotapes also represent the agency in the broadest sense; these include discus.4>ns of key issues and events by agency executives, public service announcements, and programs designed to educate regulated industry. There are a nwnber of 8-, 16-, and 35-mm films that have not yet been transferred to videotape. All of the historically significant films have been deposited in the film archives in the History of Medicine 1 Division of the National libruy of Medicine. The History Office is in the proc~ of cataloguing the hundreds of films and audiotapes in this collection. In addition to this office's visuals, the Public Affairs Office maintains a collection of photos used in the FDA Today newsletter since that publication began in 1974. This should sufficiently introduce the researcher to the published and unpublished resources on the history of the FDA. Many other sources exist, cspccially in the secondary literanuc on the agency; IDA History Office staff can assist in identifying additional works that are more directed toward a person's interests. The full-time staff here is small and our time reserved for historical research is not great. 9 Thus, we encourage those with an interest in the history artifacts, and other documentary material dating from of the FDA to apply this concern to generate narrative and the earliest era of the agency's history. interpretation of FDA's past. Regulatory history can be Lofsvold and Porter met with Professor Young, who immensely beneficial to the discussion of public policy and, shared with them interviews on the history of food and thus, immensely rewarding to the researcher. drug control that he and his students had developed over the years. The former FDA employees soon schooled THE FDA HISTORY OFFICE themselves in the techniques of oral history through one EVOLUTION of the workshops offered by the Oral History Association, a national organization of oral historians. In addition, The origins of the FDA History Office can be traced they contracted with the NLM to preserve the tapes and back to March 1968, when Commis,gonerJames Goddard tranScripts of these oral history interviews as they were assigned Wallace Janssen, a Public Information Specialist completed. and Special Assistant to the Assistant Commissioner for As the volume of their task became greater, in 1986 Education and Information, the responsibility of estab Lofsvold and Porter recruited another long-time FDA lishing an agency-wide Historian's Office. The office was employee, Ronald Ottes, who worked out of headquan located within the short-lived Science Information Fa ers conducting interviews and editing transcripts. Follow cility, butJanssen reported directly to the Commissioner. ing Porter and Lofsvold's retirement, Robert Tucker, Three months later Janssen engaged James Harvey another Rockville employee, arrived as the second oral Young, a distinguished scholar from Emory University historian in 1994. To date there are over 100 oral histories and an authority on the history of food and drug control, in the collection at NLM, accompanied by an updated as a Consultant on History. Also in 1968, Young received cumulative index to virtually all the tranScripts. a grant from the National Library of Medicine to begin conducting oral histories with former FDA officials and In 1984 the agency's history function-by this time others who were pertinent to his work in progress on the housed in the Office of Legislative Affairs-was rein history of the FDA. The tapes and tranScripts were de stituted formally as the FDA History Office and placed posited in the History of Medicine Division of the in the Office of Regulatory Affairs. The latter, a descend National Library of Medicine, pan of the National ant of the early chemists and inspectors in the Bureau Institutes of Health in Bethesda, Maryland (NLM). of Chemistry and a pan of the FDA especially rich with career employees, was a likely pan of the agency to foster Janssen continued as FDA Historian after 1975 as a the growth of the history program. The History Office reemployed annuitant, and in 1976 a Historian Staff was to be established in the Office of the Commissioner, the staff to include a full-time professional historian. How ever, a government hiring freeze aborted this effort, and this proposal was no longer pursued. The following year FDA gave Young a contract to permit him to pursue research for his history of the agency. In 1977, long-time FDA employees Fred Lofsvold and Robert Porter wrote a memo to the Executive Director of Regional Operations pointing out their growing concerns about the lack oforganized and sustained efforts to collect and preserve documents, exhibits, and other material documenting the history of the agency. None of the original inspectors appointed in 1907 was alive by that time, but several retired former employees from the 1920s and 1930s were still around. The recent deaths of two FDA retirees who "knew all kinds of things that were now lost to history' ' highlighted the need to institute a means to recover these memories before it was too late. Lofsvold and Porter proposed that, in addition to seeking documentary information from these former em ployees, their recollections be collected and preserved as a supplement to the written record. Lofsvold and Porter recognized that these interviews would be a valuable resource in the recruiting and training of new employees, and a tool to engender the kind of esprit de corps they had experienced in the agency. Later that year, Commis sioner Donald Kennedy signed a memo to all Food and A# m•MtiglllioNI -pk of 1~. w/Mh t11111 shoum to Drug Administration field offices enlisting their help in C1U1Se rJrrnn4li& birth tlefecls. 1111/fecuJ tholllll#lls of IM!ms, identifying and collecting documents, photographs, and mostly ;,, &trope, in the "1le 19JOs 1111J ellfly 1960s. 10 ranained agency-wide in scope. Also, it mwned additional mcmoty of IDA. This includes but is not limited to the responsibilities, including the oral history project and the collection and preservation of paper records, oral histories, program to oollect and presmc hisrorically significant papers objects (although producing e:xh.ibits really is more a and objects (sec Functions below). research enterprise), photographs, videotapes, and so on. The full-time professional staff was increased to fulfill Consultation consists of broad assistance to and colla the office's expanded mission. Suzanne White Junod boration with our fellow IDA employees, historians, and (Ph.D., Emory Univemty) was hired in 1984 a.s a one-year other outsiders a.s national experts on the history of the intern and given a permanent position the following year. regulation offoods, drugs, devices, biologlcs, and cosmetics. She specializes in the history of food regulation. John Infonmtion, usually nattow in scope, is provided on a fre Swann (Ph.D., Univcisity of Wisconsin) was hired in 1989. quent basis to a host of individuals representing many His specialty is the history of drug rcguhtion. The appoint diffetent institutions and organizations. These arc divided ment of Donna Hamilton (B.A., Messiah College) in 19<)4 roughly equally bctwccn IDA queries and ~ originating as an entry-level historian rounded out the staff. outside the agency. The following exemplifies some of the activities of the History Office: Research: • development of historical background on legislative initiatives • creation of briefing documents on precedents to major organizational dwlges in the agency • background papers on policy considerations • scholarly articles and monographs on select area.s of scientific and regulatory history Doctlmenllllion: • oral history interviews to fill in gaps in the papct record (sec below) • collection, prcsctv:ltion, and e:xh.ibition of museum objects illustrating the history of the agency (sec below) • identification and preservation of historically signifiant records • development of commemorations of significant agency events and milestones Consulllllion: • fuilitation of scholarly studies of IDA history • referee and review of articles, books, and grant applications in the general area of IDA history • promotion of a.ccurate and informed IDA history. in cluding sponsotship of a kcturc series for IDA employ ees and intmction with coUcagucs in other government agencies and prof~onal organizations Information: • on-the-spot information to ccntcis, offices, and all fidd offices FUNCTIONS • historically-related freedom of information queries The mission of the IDA History Office is to increase • reference or guidance for industry, law firms, students, knowlcdgc of the history, m.imoo, and activities of the IDA the media, foundatioos, historical societies, and anyone and its predecessor, the Bureau of Chcmistty of the U.S. else with a question about the agency's past Department of Agriculture. The office provides pmpcctivc on cwrcnt policy objectives and increases public under THE ORAL HISTORY PROGRAM standing ofIDA's purpose and function. In general, office As previously mentioned, this project ha.s produced over activities concern rescan:h, documentation, consultation, one hundred cumulatively indexed interviews; trarucripts and infonnation. arc available at the Nl.M and Emory University. The funner Research includes but is not limited to the prepantion also ha.s the interview tapes. Individuals interviewed rep of publishable aniclcs, long-term projects designed to result resent a broad spectrum of the agency's activities. Included in monographs, and staff papers in area.s where the IDA arc oral histories with fonncr IDA Commissioners, scient Historian believes there is a need for tcscan:h. This function ists, executive officers, early inspectors and analysts, pubic infonns all other activities the office pursues. Documen information and consumer information officers, and many tation refers to our role a.s preservers of the institutional others. The interviews of James Harvey Young and his 11 srudems, which are included in the cumulative index, maimed many patients in this country and thereby rev include Morris Fishbein, former editor of the journal of olutionized drug laws in 1938 and 1962, respectively, as the Ameriam Medical A.t.ro&iaticn, Robert Fischelis, former well as Lash Lure, a synthetic aniline eyelash dye that Secretary of the American Pharmaceutical ~tion, and blinded many women in the 1930s, before cosmetics Rexford Tugwell, Under Secretary of the Department of came under regulation. Agriculture during the New Deal. The oral histories have had wide use within and outside of the agency. The interviews have served as the basis for briefing reports for virwally all centers and offices in the FDA. They arc frequently consulted by historians and others interested in the development of FDA and its func. tions. In addition, they have been an important reference for new hire training of investigators, analysts, consumer affairs officers, and others. The success of this program has been due largely to the involvement of experienced employees, people who have spent their entire careers in various program areas of the Food and Drug Administration. By applying their collective experience in the selection of those to be interviewed, these former employees have ensun:d that the oral histories reflect the depth and breadth of FDA's regulatory and scientific experience. While professional historians on staff and outside the agency can and do provide some questions, the interviews have a special interest, accuracy, and flow because they take place between like-minded colleagues. No matter how un Lrlsh l.Mre 11N1S o"e of the proJ11tts FDA useJ to illuslrllte inhibited the interviewee may be, the success of an oral the '1111111 shortcommgs of the 19()6 Act. history-and thus the success of an oral history program The objects arc organized under many categories and dcpcnds on the ability of the interviewer to push the ~on subcategories, determined by the agency's regulatory in the direction most likely to fill in the gaps in our un jurisdictions: pharmaceuticals (including labels, promo demanding of FDA history. tional matter, drug containers, and weight loss pharma THE MUSEUM COLLECTION ceuticals-the latter because of the volume of such objects), biologic agents, foods (including vitamins, la One of the first actions Lofsvold and Porter took, in con· bels, and promotional items), medical devices, cosmetics, junction with the oral history program, was to recruit veterinary feed and drugs, equipment used for inspec sub~ions of significant artifacts from the field offices. tions and for laboratory analyses (mostly chemical and These, along with a wide variety of objects representing microbiological), quack products (including devices, self-contained individual collections and miscellaneous ac pharmaceuticals, foods, biologics, and cosmetics), pest quisitions gathered from unknown sources over the past icides, and colors. Finally, the collection includes ephem dcades, make up the museum collection of the FDA His eral objects, including awards that employees or offices tory Office. All the objects, which total about 1100 indi received and unusual company promotional items not vidual items, illustrate products the FDA regulates, and included elsewhere, such as paper-weights, letter openers, many document key enforcement cases in the history of and pill trays. the agency. In addition to these, the Smithsonian Institu Historically, the exhibition of objects has had a prom tion, the St. Louis Science Center, and the Museum of inent role at the FDA. For example, in the 1930s the Questionable Medical Devices in Minneapolis have a agency collected Lash Lure and scores of other fraudulent significant number of objects on loan from the FDA. and dangerous products for an exhibit-dubbed by a For example, the collection includes a box of Pillsbury reporter the "American Chamber of Horrors" -that Blueberry Pancake Mix, which the FDA seized in 1959 would demonstrate to Congress and the public the shon for misbranding. Contrary to the listed ingredients and comings of the 1906 Food and Drugs Act. In the late the picture on the box, this product had no blueberries. 1950s and early 1960s the agency organized a room of The collection also includes bogus bust developers such photos and objects to illustrate the hazards of quackery. as Lady Ample, seized in the 1960s, and misbranded and An FDA Museum informed visitors in the 1970s about dangerous faux exercise devices, including different how the agency administered the 1906 and 1938 acts. models of the Rclax2cizor, against which FDA took action Today the FDA History Office manages photo and arti several times in the 1970s. Other notable items included fact exhibits in several display cases in the Parklawn in this collection arc samples of Elixir Sulfanilamide and Building in Rockville and in the Federal Building 8 in Kevadon (thalidomide), the culprits that killed or the District of Columbia. 12 STAFF Wallace Jaosmi: John Swann: In 1968 he was named the fiat Historian at FDA. Origi Hired as Historian in 1989. Received Ph. D. from the nally joined FDA in 1951 as Asmtant to the Commis Univetsiry of W.iscoosin (Pharmacy and History of Sci sioner to head the agency's public infomwion effon. ence) in 1985. Specializes in the history of drugs and drug regulation. Suzanne White Junod: Served a one-year temporaiy appoinunent in the FDA Donna fbmilton: History Office in 1984, then joined the office as Historian Stmcd as a R.esean:h Assistant with the FDA History in 1985. Received Ph. D. from Emory University (His Office in 1991. Received B. A. (History) from Mesmh tory) in 1994. Spc:cializcs in the histoty offood and food College in 1992. Hired into the Historian series in 1994. 1egularion. Rohen Tucker: Ronald Ones: Appointed to the Oral History Progr.un in 1994. Origi Appointed to the Oral History Progmm in 1986. Origi nally began as a Food and Drug Officer with FDA in nally hired by FDA as a Oiemist in 1957, and retired 1962; retired from the Division of Fcdei:al State Rela in 1985 as Dittctor of the Office of Regional ()pei2tions tions in the Office of Regulatory Affairs in 1992. in the Office of Regulatory Affalls. 13 r