Researching FDA with Unpublished Sources
In general, agency records prior to 1938 are part of the National Archives and housed at the Archives II facility in College Park, Maryland. Thereafter, records are under FDA's jurisdiction and require permission of the agency to consult them; these are housed at the Federal Records Center in Suitland, Maryland, or at agency headquarters. The collection at the National Archives consists of more than 2500 cubic feet of records, including general correspondence, seizure recommendations, proposed legislation, papers of the Board of Food and Drug Inspection, enforcement records for the Tea Importation Act of 1897, and milk inspection documents. The reference archivist with jurisdiction over this record group (RG 88) has various finding aids to the collection.
Other collections in the National Archives might be useful in researching the history of product regulation that now falls under FDA. For example, the Public Health Service Records, RG 90, amply document the Hygienic Laboratory's (and later the National Institutes of Health's) supervision of the manufacture of antitoxins, serums, and other preparations following the Biologics Control Act of 1902. That function fell to FDA in 1972. Record Group 90 also houses some documents from a predecessor of FDA's Center for Devices and Radiological Health, the Bureau of Radiological Health of the PHS, which came to FDA in 1971. Responsibility for caustic poisons, unsafe toys, and other product safety concerns, which had resided in FDA since 1927, passed to the new Consumer Product Safety Commission in 1973.
The Federal Trade Commission (RG 122) began regulating advertising of drugs soon after its creation in 1914; it continued in this role under stronger legislation in 1938, when other products were added to its responsibilities, such as medical devices and cosmetics. The Post Office also had an active interest in regulation pertinent to FDA responsibilities. In fact, this department pursued drug fraud perpetrated through the U. S. mail prior to the 1906 act. The records of the Post Office Department in general (RG 28) and its Bureau of the Chief Inspector in particular (same record group) would be a valuable entree for the researcher interested in this line of inquiry.
Considering the roots of FDA, many records connected with agriculture in the federal government, such as the Records of the Office of the Secretary of Agriculture (RG 16), might be of use as well. The Records of the Bureau of Narcotics and Dangerous Drugs (RG 170), the agency that preceded the Drug Enforcement Administration, include material on the legitimate manufacture, illicit distribution, and abuse of narcotics, stimulants, and depressants--all products that the FDA regulated at one time or another.
Many collections other than those in government archives are relevant to the study of the regulation of foods, drugs, and so on. Certainly a useful place to begin would be either the National Union Catalogue of Manuscript Collections or the Research Library Information Network (RLIN) on-line database. A useful group of pre-1938 records are the Harvey Washington Wiley Papers at the Library of Congress Manuscripts Division. Nearly 250 boxes document the life and career of the man who headed the predecessor of FDA from 1883 to 1912. Included in the Wiley Papers are several diaries and a bibliography of publications of the Bureau of Chemistry from 1862 to 1924. The Library of Congress also houses the collected papers of Wiley's wife, Anna Kelton Wiley, which contains some papers of Harvey Wiley from about 1900 to 1930.
The American Medical Association's Historical Health Fraud and Alternative Medicine Collection is an excellent source of correspondence, circulars, clippings, and other matter on the history of quackery. This collection derives from the AMA's Department of Investigation and covers most of the twentieth century, including extensive material on Harry Hoxsey, Albert Abrams, rheumatism cures, and hundreds of quacks and quack products. The AMA published a very useful finding aid to the collection, Arthur W. Hafner et al., Guide to the American Medical Association Historical Health Fraud and Alternative Medicine Collection (Chicago: American Medical Association, 1992).
Researchers should be aware that the agency is bound by legislative fiat not to divulge confidential information such as trade secrets or patient information. Accordingly, for most records under FDA's control one must begin by filing a freedom of information (FOI) request with the agency. This is most efficiently done after consulting with the History Office about the sort 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.
FDA has a variety of records, but most fall within the following groups: case files, AF files, decimal files, new drug applications, and hearing clerk's files. Case files document the litigation stemming from violations of food and drug legislation, from the initial complaint filed by the U. S. Attorney 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 headquarters about the progress of the proceedings, conversations overheard, and sometimes the results of "tailing" a suspicious defense witness outside the courtroom. Complete transcripts of trials sometimes are in the case file. However, one should be aware that the courts themselves might be a better source for transcripts and supporting documentation, especially for cases accepted on appeal by the Supreme Court. The above-mentioned Notices of Judgment are an important tool to be used in conjunction with the case files, since these summarize--often in considerable detail--the same legal proceedings documented in the case file. They also include the key numbers identifying the location of the case jackets. Thus, the researcher must consult the published Notice first before examining the case file. The Case Files are in the process of being transferred formally from the FDA to the History of Medicine Division, National Library of Medicine, and can be viewed at that institution. AF Files and Decimal Files
AF Files and Decimal Files
The so-called AF files reveal much about FDA's interaction with the regulated industry. These include correspondence between the agency and companies, as well as inspection reports on the firm. Used together with the case files, the researcher can derive a full appreciation for the enforcement of food and drug laws. One can trace the story of a violative item beginning with FDA's initial inspection of a company, to seizure of the product in question, to final resolution of the affair in the courts.
The agency's decimal files include the widest ranging topics of all the collections. These files, which represent the totality of the agency's concerns, are arranged by subject; each subject is given a discrete number between 000 and 999. The system, which is indexed alphabetically by subject and by number, has been updated constantly through time. For example, this system assigns food softeners the number 489.1, radio advertising for cosmetics is 580.71, complaints from businesses about enforcement methods is 691 whereas consumer complaints about the laxness of enforcement procedures is 609.3, counterfeit drugs are 500.24, exporting of medical devices is covered in 570.66, regulations for pesticides in foods is 051.12 (FDA regulations in general are covered under 051), and so on.
New Drug Applications
New drug applications (NDAs) began in 1938 when manufacturers were mandated under the Food, Drug, and Cosmetic Act to prove the safety of their drugs before FDA could approve the product for marketing. Companies submitted chemical, pharmacological, and clinical evidence to the agency to establish safety and--following the 1962 drug amendments--efficacy of their pharmaceuticals. The volume of each NDA has grown over the years to meet the changing laws and regulations, such that the earliest NDAs are merely a fraction of what manufacturers submit today. At present there are more than 20,000 NDAs. This group of records document, more than any other single collection anywhere, the evidence for the revolution in drug therapy in this century.
Most of each NDA is confidential because of the commercial information they required; in addition, there are privacy act concerns that prevent release of most of the NDA. However, there is still substantial so-called approvability correspondence that is releasable, and since the 1970s the FDA has issued a summary basis of approval (SBA) for many NDAs. The SBA distills the voluminous data and conclusions in the application (for other product approvals, see Dockets Management Branch Files below, or consult the relevant Center). Efforts are underway within the agency, and with the assistance of a distinguished committee of outside and internal experts on drug information and the history of pharmacology, to develop a systematic means of identifying historically significant NDAs, securing their preservation, and arranging for researcher access. This, combined with similar efforts aimed at randomly selected NDAs, will help capture changes in drug evaluation methodology over time.
Dockets Management Branch Files
Many files of the Dockets Management Branch of FDA overlap other record groups that have been discussed, but since this broad group of public records is under the jurisdiction of a single office, they will be cited here. Noteworthy holdings of this office include records from evidentiary hearings of the Administrative Law Judge; Hearing Clerk's records; summaries of approval for new animal drugs and new medical devices, including labelling and environmental impact statements; and papers pertaining to citizens' petitions. Of particular interest to researchers are the records of public comments on proposed rulemaking, i. e., responses to proposed regulations published in the Federal Register, and the minutes and transcripts of advisory committee meetings (with the exception of those portions of meetings that are closed to the public).
Researchers should also be aware of the rich collections of non-textual documentation of FDA history. The National Archives has the most extensive collection of prints and photographs of or related to FDA. Record Group 88 has nearly 4,000 photographs before the 1938 act. Post-1938 photos number about three times that many. For example, pictures of FDA activities from 1962 to 1977, mostly from FDA Papers and FDA Consumer, total 61 boxes. Fortunately, there is a finding aid arranged both by subject (for the first twenty-one boxes in this collection) and by location of pictures from individual issues of the two publications above (for the remaining forty boxes); the cumulative indices to FDA Papers and FDA Consumer thus 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 Congress include ten boxes of prints and photographs.
The History Office has a sizable 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 portraits. The collection of videotapes also represent the agency in the broadest sense; these include discussions of key issues and events by agency executives, public service announcements, and programs designed to educate regulated industry. There are a number 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 Division of the National Library of Medicine. NLM also has several dozen boxes of videotapes from the 1990s, many of which are broadcast news reports on FDA subjects. The library has a catalogue of the several hundred tapes in this group. In addition to the History Office's collection of photographs, the FDA Public Affairs Office maintains a collection of images used in the FDA Today newsletter since that publication began in 1974.