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  1. FDA History Research Tools

Researching FDA with Published Secondary Sources

The following bibliography pulls from the ever-growing corpus on the history of the FDA and related issues a sample covering different subject areas; it is by no means intended to be comprehensive. Most of these are interpretive secondary sources with ample references--if not bibliographies--to additional literature in the field. This should be considered a good starting point to investigate the field.

General Sources

Anderson, Oscar E., Jr. The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food. Chicago: University of Chicago Press, 1958 (masterful biography; also an excellent early history of the 1906 act and the predecessor agency of FDA).

Brannon, Michael. "Organizing and Reorganizing FDA." In Seventy-Fifth Anniversary Commemorative Volume of Food and Drug Law, 135-73. Washington: Food and Drug Law Institute, 1984 (documents the myriad structural changes within the agency).

Carpenter, Daniel P., The Forging of Bureaucratic Autonomy: Reputations, Networks, and Policy Innovation in Executive Agencies, 1862-1928 (Princeton, Princeton University Press, 2001).

Christopher, Thomas W. "Articles on Food and Drug Law." Food, Drug, Cosmetic Law Journal 13 (1958): 487-98 (dated but useful bibliography drawn exclusively from legal periodicals, arranged by subject).

FDA Consumer magazine, vol. 15, no. 5 (1981) (this issue commemorating the 75th anniversary of the 1906 act includes a variety of historical articles).

Hilts, Phil. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred A. Knopf, 2003.

Jackson, Charles O. Food and Drug Legislation in the New Deal. Princeton: Princeton University Press, 1970 (on the formation of the 1938 Food, Drug, and Cosmetic Act).

Juhnke, Eric S. Quacks & Crusaders: The Fabulous Careers of John Brinkley, Norman Baker, and Harry Hoxsey. Lawrence, Kansas. University Press of Kansas, 2002.

Junod, Suzanne White. "The Class of '39: Implementing the 1938 Food, Drug, and Cosmetic Act," Journal of the Association of Food and Drug Officials of the United States 52:4 (1988), 10-25 (history of the implementation of selected provisions of the 1938 Food, Drug, and Cosmetic Act).

Junod, Suzanne White. FDA and Commercial Free Speech: A New Regulatory World. The Society for History in the Federal Government, Occasional Papers, Number 4, 2004, pp. 41-53.

Kay, Gwen. " Healthy Public Relations: The FDA's 1930s Legislative Campaign." Bulletin of the History of Medicine 75 (2001): 446-487.

Lamb, Ruth deForest. American Chamber of Horrors: The Truth about Food and Drugs. New York: Farrar and Rinehart, 1936 (on the many shortcomings of the 1906 act, and why a new law was needed, by the " Chief Educational Officer" at FDA).

Rossiter, Margaret W.  Women in Science: Struggles & Strategies to 1940: Volume I: Baltimore: Johns Hopkins University Press, 1982. (Three volume series portraying the challenges and accomplishments of women in science).

Rossiter, Margaret W. Women in Science: Before Affirmative Action, 1940-1972: Volume II: Baltimore: Johns Hopkins University Press, 1995.

Rossiter, Margaret W. Women in Science: Forging a New World Since 1972Volume III: Baltimore: Johns Hopkins University Press, 2012.

Swann, John P. "Food and Drug Administration." In A Historical Guide to the U. S. Government, George Thomas Kurian, ed., pp. 248-254. New York: Oxford University Press, 1998 (traces general trends in food, drug, cosmetic, and device regulation from FDA's origins to the present).

Wiley, Harvey W. An Autobiography. Indianapolis: Bobbs- Merrill, 1930 (an illustrated and indexed life and career of the father of FDA).

Young, James Harvey. "Food and Drug Administration." In Government Agencies, Donald R. Whitnah, ed., pp. 251-57. Westport, Conn.: Greenwood Press, 1983 (a brief but succinct history of FDA, with a short bibliography).

Young, James Harvey. "Food and Drug Enforcers in the 1920s: Restraining and Educating Business," Business and Economic History, 2d ser., 21 (1992): 119-28 (enforcement policy under the 1906 act).

Young, James Harvey. The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America. Princeton: Princeton University Press, 1967 (indicative subtitle; includes much on FDA).

Young, James Harvey. "From Oysters to After-Dinner Mints: The Role of the Early Food and Drug Inspector," Journal of the History of Medicine and Allied Sciences 42 (1987): 30-53 (creation, training, and work of the first FDA inspectors).

Young, James Harvey. " The Pig That Fell into the Privy: Upton Sinclair's The Jungle and the Meat Inspection Amendments of 1906," Bulletin of the History of Medicine 59 (1985): 467-80 (history of event spurring passage of the 1906 Food and Drugs Act).

Young, James Harvey. Pure Food: Securing the Federal Food and Drugs Act of 1906. Princeton: Princeton University Press, 1989 (definitive history of this landmark Progressive era legislation, including an historiography of the subject).

Sources on Drug, Biologic, and Cosmetic Regulation

Anderson, Ann. Snake Oil, Hustlers, and Hambones: The American Medicine Show. Jefferson, N.C., McFarland and Co., 2000 (excellent, readable history of the American medicine show from its origins in medieval Europe to its heyday in the 1890s and its final curtain call in the mid-20th century with Dudley J. LeBlanc's outrageous showmanship promoting Hadacol).

Anderson, Lee, and Higby, Gregory J. The Spirit of Voluntarism, A Legacy of Commitment and Contribution: The United States Pharmacopeia, 1820-1995. Rockville, Md.: USP, 1995 (comprehensive history of the private but officially recognized drug standard-setting compendium)

Blake, John B., ed. Safeguarding the Public: Historical Aspects of Medicinal Drug Control. Baltimore: Johns Hopkins Press, 1970 (several useful papers and discussions thereof, including those on 19th century drug regulation, drug regulation under the 1906 act, and regulation after 1938).

Cooper, Dale E. "Adequate Controls for New Drugs: Good Manufacturing Practice and the 1938 Food, Drug, and Cosmetic Act," Pharmacy in History 44:1 (2002): 12-23 (how the 1938 act incoroporated manufacturing controls).

Donegan, Thomas J. "Fifty Years of Cosmetic Safety: A Government and Industry Partnership." Food and Drug Law Journal 50, Special Issue (1995): 151-162.

Dowling, Harry F. Medicines for Man: The Development, Regulation, and Use of Prescription Drugs. New York: Alfred A. Knopf, 1970 (internalistic but very useful overview of the subject).

Gostin, Lawrence O.; Arno, Peter S.; and Brandt, Allan M. " FDA Regulation of Tobacco Advertising and Youth Smoking: Historical, Social, and Constitutional Perspectives." JAMA 277 (1997): 410-418.

Hilts, Philip J. Smokescreen: The Truth behind the Tobacco Industry Cover-Up. Reading, Mass.: Addison-Wesley, 1996.

Hutt, Peter Barton. "Investigations and Reports Respecting FDA Regulation of New Drugs." Clinical Pharmacology and Therapeutics 33 (1983): 537-48, 674-87 (primarily descriptive, this serves as an excellent reference source on the role of outsiders, i.e., advisory committees, in shaping drug regulation policy of FDA, from 1939 to 1983).

Janssen, Wallace. "Outline of the History of U. S. Drug Regulation and Labeling." Food, Drug, Cosmetic Law Journal 36 (1981): 420-41 (a useful overview, especially with respect to misbranding).

Junod, Suzanne White. "Diethylene Glycol Deaths in Haiti," Public Health Reports 115:1 (January 2000), pp. 78-86. (official history of the deaths in Haiti from diethylene glycol-contaminated glycerine in the summer of 1996)

Junod, Suzanne White. "An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation," Food, Drug, Cosmetic Law Journal 55:1 (2000), pp. 161-183; see also Pharmacy In History 42:1-2 (2000) pp. 13-35 (exploration of the origins of the Homeopathic Pharmacopeia in the 1938 Food, Drug, and Cosmetic Act and its sponsorship by Senator Royal Copeland, as well as FDA's subsequent regulation of homeopathy).

Kaplan, Alan H. "Fifty Years of Drug Amendments Revisited: In Easy-to-Swallow Capsule Form." Food and Drug Law Journal 50, Special Issue (1995): 179-196.

Kay, Gwen. "Regulating Beauty: Cosmetics in American Culture from the 1906 Pure Food and Drugs Act to the 1938 Food, Drug, and Cosmetics Act." Ph. D. diss., Yale University, 1997.

Kendall, Edward C. Memoirs of a Hormone Hunter. New York: Charles Scribner's Sons, 1971.

Kessler, David A. A Question of Intent: A Great American Battle with a Deadly Industry (New York: Public Affairs Press, 2001). (FDA Commissioner's personal account of the agency's decision to declare nicotine a drug and assert jurisdiction over tobacco)

Kondratas, Ramunas. " Biologics Control Act of 1902." In The Early Years of Federal Food and Drug Control, 8-27. Madison, Wis.: American Institute of the History of Pharmacy, 1982 (on the coming of the federal statute that brought vaccines, sera, and antitoxins under regulation).

Korwek, Edward L. "Human Biological Drug Regulation: Past, Present, and Beyond the Year 2000." Food and Drug Law Journal 50, Special Issue (1995): 123-150.

Lederer, Susan E. Subjected to Science: Human Experimentation in America before the Second World War. Baltimore: Johns Hopkins University Press, 1995 (examines the development of medical research ethics before World War II; includes background on informed consent, animal research, ethics in human trials).

Maeder, Thomas. Adverse Reactions. New York: William Morrow, 1994 (good regulatory history of an early antibiotic, chloramphenicol, and its rare but fatal side effect, aplastic anemia).

Marks, Harry M. "Revisiting 'The Origins of Compulsory Drug Prescriptions.'" American Journal of Public Health 85 (1995): 109-115 (analysis of the influences leading to the 1951 Durham-Humphrey Amendment).

Marks, Harry M. The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990. Cambridge, Cambridge University Press, 1997 (history of the development of clinical trial research in the U.S.)

McFadyen, Richard E. "The FDA's Regulation and Control of Antibiotics in the 1950s: The Henry Welch Scandal, Felix Marti-Ibanez, and Charles Pfizer & Co." In Bulletin of the History of Medicine 53:2 (Summer 1979), pp. 159 - 169.

McFadyen, Richard E. "Thalidomide in America: A Brush with Tragedy." Clio Medica 11, no. 2 (1976): 79-93 (good companion piece to Young's " Sulfanilamide," because thalidomide had a similar impact on the passage of major drug regulatory legislation, the Kefauver-Harris Drug Amendments of 1962).

McFadyen, Richard E. "Estes Kefauver and the Drug Industry." Ph.D. diss., Emory University, 1973 (a background for the enactment of the drug amendments of 1962).

Solomon, Joel M. "Legislation and Regulation in Blood Banking." In Federal Legislation and the Clinical Laboratory, Morris Schaeffer, ed., pp. 143-171. Boston: G. K. Hall, 1981.

Sonnedecker, Glenn. "Drug Standards Become Official." In The Early Years of Federal Food and Drug Control, 28-39. Madison, Wis.: American Institute of the History of Pharmacy, 1982 (how the United States Pharmacopoeia and the National Formulary became official drug compendia under the 1906 act).

Swann, John P. "FDA and the Practice of Pharmacy: Prescription Drug Regulation to 1951." Pharmacy in History 36 (1994): 55-70 (reference to the basic drug laws from the 19th to mid-20th centuries, and cooperation and conflict between organized pharmacy and FDA, especially regarding amphetamines and barbiturates).

Swann, John P. "The 1941 Sulfathiazole Disaster and the Birth of Good Manufacturing Practices." PDA Journal of Pharmaceutical Science & Technology 53 (1999): 148-153; see also Pharmacy in History 41 (1999): 16-25 (story of the hundreds of deaths and injuries from barbiturate-tainted sulfa, and the impact of this tragedy in shaping FDA-mandated manufacturing controls).

Swann, John P. "Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act." In The Pharmaceutical Regulatory Process, ed. Ira R. Berry, pp. 1-46. New York: Marcel Dekker, 2005 (overview of the social, scientific, economic, and political circumstances that helped conceive and shape U.S. drug and biologics laws and regulations, from the 1813 Vaccine Act to the 1962 Kefauver-Harris Drug Amendments).

Swann, John P. "Sure Cure: Public Policy on Drug Efficacy Before 1962," in The Inside Story of Medicines: A Symposium, Gregory J. Higby and Elaine C. Stroud, eds., pp. 223-261. Madison: American Institute for the History of Pharmacy, 1997 (evolution of policies of public and private organizations in the U. S. on the effectiveness of medicines from the 19th to the 1962 Kefauver-Harris amendments).

Taylor, Michael R. "History of Cosmetic Color Additive Regulation: Creative Maneuvering by FDA Bodes Well for the Future." Food Drug Cosmetic Law Journal 37 (1982): 152-162.

Temin, Peter. Taking Your Medicine: Drug Regulation in the United States. Cambridge, Mass.: Harvard University Press, 1980 (this economist raises many interesting issues deserving further study; his interpretations follow rather predictably from his free-market underpinnings).

Ward, Patricia Spain. "Who Will Bell the Cat?: Andrew C. Ivy and Krebiozen," Bulletin of the History of Medicine 58 (1984): 28-52 (history of quack cancer drug, Krebiozen, and the strange story of the scientist, Andrew C. Ivy, who endorsed it and thus ended his professional career).

Young, James Harvey. The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation. Princeton: Princeton University Press, 1961 (the subtitle conveys the subject of this pioneering study).

Young, James Harvey. "Sulfanilamide and Diethylene Glycol." In Chemistry and Modern Society: Historical Essays in Honor of Aaron J. Ihde, John Parascandola and James C. Whorton, eds., pp. 105-25. Washington, D.C.: American Chemical Society, 1983 (on the key event in 1937 that precipitated statutory drug safety).

Young, James Harvey. American Health Quackery. Princeton: Princeton University Press, 1992 (a collection of his published essays on this theme, with a new essay on AIDS quackery).

Sources on Food, Device, and Veterinary Medicine Regulation

Apple, Rima D. Vitamania: Vitamins in American Culture. New Brunswick: Rutgers University Press, 1996 (a discussion of America's love affair with vitamins incorporating FDA's regulatory perspective).

Belasco, Warren J. Appetite for Change: How the Counter Culture Took on the Food Industry, 1966-1988. New York: Pantheon Books, 1989 (discusses the countercultural critique of governmental policy towards food and food additives between the 1960s and the 1980s).

Bosso, Christopher J. Pesticides and Politics: The Life Cycle of A Public Issue. Pittsburgh: University of Pittsburgh Press, 1987 (good general history of pesticides regulation, but contains a few errors regarding regulation).

Foote, Susan Bartlett. Managing the Medical Arms Race: Public Policy and Medical Device Innovation. Berkeley: University of California Press, 1992 (mostly oriented toward contemporary policy, but much is on the history of medical device regulation).

Hochheiser, Sheldon. "Synthetic Food Colors in the United States: A History under Regulation." Ph.D. diss., University of Wisconsin, 1982.

Hutt, Peter Barton. "A History of Government Regulation of Adulteration and Misbranding of Medical Devices." Food, Drug, Cosmetic Law Journal 44 (1989): 99-117 (a good, succinct survey of the history of device regulation outside of quackery).

Hutt, Peter Barton, and Hutt, Peter Barton, II. "A History of Government Regulation of Adulteration and Misbranding of Food." Food, Drug, Cosmetic Law Journal 39 (1984): 2-73 (contains complete overview of governmental food regulation).

Ihde, Aaron J. " Food Controls Under the 1906 Act." In The Early Years of Federal Food and Drug Control, 40-50. Madison, Wis.: American Institute of the History of Pharmacy, 1982 (enforcement policy under the 1906 act, including the role of outsiders).

Janssen, Wallace F. "Inside the Poison Squad: How Food Additive Regulation Began." Association of Food and Drug Officials Quarterly Bulletin 51, no. 2 (1987): 68-72 (the story of Wiley's famous experiment to illustrate the hazards of additives using volunteer subjects).

Junod, Suzanne White. "The Chemogastric Revolution and the Regulation of Food Chemicals." In Chemical Sciences in the Modern World, Seymour Mauskopf, ed., pp. 322-355. Philadelphia: University of Pennsylvania Press, 1993 (history of the regulation of food chemicals in the post-World War II era).

Junod, Suzanne White. "U.S. Federal Food Standards: The Case of the Peanut Butter and Jelly Sandwich," in Food, Science, Policy and Regulation in the Twentieth Century: International and Comparative Perspectives, in David F. Smith and Jim Phillips, eds., pp. 167-188. London: Routledge Press, 2000 (history of FDA policies in regulating food standards from 1900 to the present, illustrated).

Kassel, Mark A. "From A History of Near Misses: The Future of Dietary Supplement Regulation." Food and Drug Law Journal 49 (1994): 237-269.

Kessler, David A. "The Evolution of National Nutrition Policy." Annual Review of Nutrition 15 (1995): xiii-xxvi.

Kessler, David A., Mande, Jerold R., Scarbrough, F. Edward, Schapiro, Renie, and Feiden, Karyn. "Developing the 'Nutrition Facts' Food Label." Harvard Health Policy Review, vol. 4, no. 2 (Fall 2003): 13-24.

Leavitt, Judith Walzer. The Healthiest City: Milwaukee and the Politics of Health Reform. Madison, Wisconsin: University of Wisconsin Press, 1996. (especially pp.156-189).

Levenstein, Harvey W. Paradox of Plenty: A Social History of Eating in Modern America. New York: Oxford University Press, 1993 (continuation of previous volume beginning with the Great Depression to the present).

Levenstein, Harvey W. Revolution at the Table: The Transformation of the American Diet. New York: Oxford University Press, 1988 (discusses the changes in American eating habits as knowledge about nutrition has advanced over the century).

Marcus, Alan I. Cancer From Beef: DES, Federal Food Regulation, and Consumer Confidence. Baltimore: Johns Hopkins Press, 1994 (history of diethylstilbestrol used in cattle).

Merrill, Richard A. "Regulation of Drugs and Devices: An Evolution." Health Affairs 13, no. 3 (1994): 47-69.

Munsey, Rodney R. "Trends and Events in FDA Regulation of Medical Devices Over the Last Fifty Years." Food and Drug Law Journal 50, Special Issue (1995): 163-177.

Okun, Mitchell. Fair Play in the Marketplace: The First Battle For Pure Food and Drugs. Illinois: Northern Illinois University Press, 1986 (discusses the shortcomings and ultimate failure of three early food and drug statutes in New York, Massachusetts, and New Jersey as a prelude to the the 1906 act).

Palley, Howard A. "The Evolution of FDA Policy on Silicone Breast Implants: A Case Study of Politics, Bureaucracy, and Business in the Process of Decision-Making." International Journal of Health Services, vol 25, no. 4 (1995): 573-91.

Pendergast, Mark. For God, Country and Coca Cola: The Unauthorized History of the Great American Soft Drink and the Company that Makes It. New York: Charles Scribner's Sons, 1993 (although a history of Coca-Cola, the early history of the soft drink and later regulatory problems are of interest to FDA).

Smith, Andrew F. Pure Ketchup: A History of America's National Condiment. Columbia: South Carolina University Press (1996)

Smith, David F., and Phillips, Jim. Food, Science, Policy and Regulation in the Twentieth Century: International and Comparative Perspectives. New York, Routledge Press, 2000 (excellent edited volume containing essays on a wide variety of international food issues, including bio-engineered foods).

Soave, Orland. "History of Veterinary Medicine in the Food and Drug Administration." Journal of the American Veterinary Medical Association 199 (1991): 38-42 (on the regulation of products for veterinary use, 1906 to 1990).

"Symposium: Use of FDA-Approved Drugs in Veterinary Medicine: Prohibitions, Prerogatives, and Responsibilities." Journal of the American Veterinary Medical Association 202 (1993): 1601-1745.

Whitaker, Adelyne Hiller. "A History of Federal Pesticide Regulation in the United States to 1947." Ph.D. diss., Emory University, 1974.

White, Suzanne. "Chemistry and Controversy: Regulating the Use of Chemicals in Foods, 1883-1959." Ph.D. diss., Emory University, 1994.

Whorton, James. Before Silent Spring: Pesticides and Public Health in Pre-DDT America. Princeton. Princeton University Press, 1974 (definitive history of pesticides regulation before World War II).

Young, James Harvey. "Botulism and the Ripe Olive Scare of 1919-1920," Bulletin of the History of Medicine 50 (1976): 372-91.

Young, James Harvey. "Saccharin: A Bitter Regulatory Controversy." In Research in the Administration of Public Policy, Frank B. Evans and Harold T. Pinkett, eds., pp. 39-49. Washington D. C.: Howard University Press, 1975.

Young, James Harvey. "The Science and Morals of Metabolism: Catsup and Benzoate of Soda," Journal of the History of Medicine and Allied Sciences 23 (1968): 86-104.

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