Introduction

The papers of Frances Oldham Kelsey (1914-2015) span the years 1890-2016, with the bulk of the items concentrated between 1950 and 2000. The collection consists of two parts. Part I covers Kelsey's career as a pharmacologist and government official at the United States Food and Drug Administration (FDA), primarily from 1960 to 1990. Part II comprises the bulk of the collection and documents Kelsey career in pharmacolgy before and during her years at the FDA. Further descriptions of each part follow. Excisions of information from some of the documents in the collection were carried out by the FDA.

Part I

Part I of the papers spans the years 1913-1998, with the bulk of the items concentrated in the period between 1960 and 1990. Part I includes Kelsey's files created during her work as a pharmacologist and government official at the FDA and consists of three series: Office File , Speeches and Writings File , and Research File . Included in the papers are biographical material, correspondence, memoranda, speeches, editorials, background information and chapter drafts for a book, reports and statements, studies, press releases, newspaper and magazine clippings, reprints of articles, proceedings of hearings, research files, and other material pertaining to Kelsey's career as a researcher and regulator of investigational new drugs at the FDA.

The Office File consists of general correspondence and other material of an administrative nature documenting Kelsey's activities at the FDA primarily during the 1960s. The file of biographical material in particular contains information regarding Kelsey's receipt of the President's Award for Distinguished Federal Civilian Service in 1962 for her refusal to approve the commercial distribution of thalidomide in the United States. Following the thalidomide controversy, Kelsey was much sought after as a public speaker. Correspondence regarding invitations to speak documents her numerous engagements. Kelsey's work as an investigator is reflected by her office memoranda and by memoranda for the record which summarize her participation in conferences, interviews, telephone conversations, and other interactions. Detailed trip reports chronicle her participation in national and international conferences on pharmacology and related fields.

The historical file in the series consists of photocopies of memoranda written between 1994 and 1997 by Kelsey during the process of transferring her files to John Patrick Swann, historian at the FDA, where the collection was originally housed. Scattered throughout the papers attached to the respective item or items described, the original memoranda range in length from a sentence to three pages and describe single items as well as whole batches of material. By bringing the photocopies of the memoranda together into one location, the historical file constitutes a collection of Kelsey's reflections on her long career at the FDA. It provides valuable information on current scientific research and development, the discovery of new drugs and therapies and their effects, prominent individuals in the field, controversies within the pharmaceutical industry as well as the FDA, and day-to-day issues encountered at the workplace.

The Speeches and Writings File consists primarily of interviews, speeches, background information and chapter drafts for a book, editorials, and articles by others. Kelsey's activity as a public speaker over a thirty-year period is chronicled in the speeches file. During the early 1960s, she frequently spoke on the drug thalidomide. Other topics include promising new cures for diseases, quack remedies, and the tension between the desire of pharmaceutical companies to release new drugs on the market as quickly as possible and the regulatory mechanism of the FDA in demanding stringent drug testing. Essentials of Pharmacology , coauthored with E. M. K. Geiling and F. E. Kelsey, her husband, is represented by numerous folders of background information and drafts of chapters eight and nine. The editorials file consists primarily of brief scientific articles written by Kelsey while an editorial associate with the American Medical Association in Chicago during the early 1950s.

The Research File constitutes the largest section of material in the collection. Many of the files reflect Kelsey's research on various new drugs undergoing the regulatory process for FDA approval, such as Avazyme, Bamfolin, Daroil, Fluorouracil, Librium, Parotin, Ritalin, Triparanol, and Vesprin. Kelsey's participation on numerous committees is also documented. The computerization of scientific information during the early 1960s is reflected in the files on the National Library of Medicine and Arthur D. Little, Inc., regarding its proposal to establish an integrated agency-wide scientific information system. The material on DES (diethylstilbestrol), DMSO (dimethyl sulfoxide), and thalidomide is quite extensive and reflects the considerable attention given these controversial drugs by Kelsey. The subject of quackery appears throughout the Research File. Controversies in the field of new drug research are reflected in the files on Emanuel Revici concerning selenium diethyl dithiocarbonate (SDD) as a treatment for cancer, on William K. Summers's promotion of tetrahydroaminoacridine (THA) (Tacrine) as a treatment for Alzheimer's disease, and on Henry Turkel's request for approval of "U" series drugs as a treatment for cancer.

Folders under the heading investigational new drugs (INDs) relate to congressional legislation primarily resulting from Senator Estes Kefauver's investigations in the early 1960s. Files on congressional hearings feature the involvement of various congressional committees in reviewing and overseeing the FDA in its capacity as guarantor of the purity and efficacy of the nation's drugs. These files reflect the growing change in public attitude regarding the ethics of drug testing on selected sections of the population who often had little or no control over their involvement in new drug trials which could frequently prove life-threatening. Subject studies in vulnerable populations constitute a large section of material in the series. The testee categories include fetuses, infants, children, geriatrics, prisoners, and women of childbearing potential. The Kelsey Papers also contain numerous reports documenting studies and research which had significant effects upon the drug regulatory process in the United States during the second half of the twentieth century.

Part II

Part II of the papers spans the years 1890-2016, with the bulk of the items concentrated in the period from 1950 to 2000. Part II includes Kelsey's files covering her career in pharmacology before and during her years at the FDA. The papers are organized into the following series: Correspondence , Personal File , Office File , Speeches and Writings File , Subject File , F. E. Kelsey Files , Oversize , and Digital Files

The Correspondence contains mostly incoming letters to Kelsey from friends, colleagues, organizations, and the public. Letters sent by friends, who address Kelsey as "Frankie" and her husband as "Ellis," often discuss everyday life, current events, and persons known to both. The largest amount of correspondence relates to thalidomide, with the bulk received in 1962, as the public and others thanked Kelsey for her refusal to approve the commercial distribution of thalidomide in the United States. She continued to receive such letters for the remainder of her career. Further correspondence from friends and colleagues is located in the Personal File .

The Personal File includes biographical material, family and estate papers, and files kept by Kelsey while at the University of Chicago in Illinois and in South Dakota at the University of South Dakota in Vermillion, the Yankton State Hospital in Yankton, and her private medical practice. The biographical material includes awards and certificates, biographical sketches, curricula vitae, a large file of clippings either about or mentioning Kelsey, and material from her school days in Canada. The family and estate papers include correspondence and other material related to the death of her husband, F. E. Kelsey, and her administration of the estate of her mentor and friend E. M. K. Geiling. Under the tutelage of Geiling at the University of Chicago, Kelsey conducted advanced research in pharmacology, the posterior pituitary, and also worked on a synthetic cure for malaria. The research file, comprised mostly of article reprints involving research on pituitary and thyroid glands, seems to have been kept jointly by Geiling and Kelsey. At the University of South Dakota medical school, Kelsey carried out research involving thyroid disease, radioisotopes, and the relation of thyroid disorders to mental illness.

The Office File consists of a chronological file and other material of an administrative nature documenting Kelsey's activities at the FDA primarily from 1967 to 2000. The chronological file probably served as a central file and contains copies of outgoing correspondence and memoranda. Unfiled correspondence and memoranda that may have been intended for the chronological file are located in the Subject File of Part II under miscellany. The historical file created in the Part I: Office File series was discontinued in Part II with the memoranda kept in place throughout the collection. However, Kelsey's chronological file of some of these memoranda is contained under the heading of John Patrick Swann.

The Speeches and Writings File consists of interviews, speeches, speaking engagements, background information for a book, articles, editorials, and book reviews. Interviews are interspersed throughout the speaking engagements with the two conducted by the FDA at the beginning of the series. Kelsey's speeches cover many of the same topics found in Part I, but also treat drug laws and legislation, FDA policies and regulations, drug testing on humans, clinical investigators and investigations, good clinical practices, good laboratory practices, and teratogenic drugs and substances that can disturb embryonic or fetal development leading to birth defects or pregnancy termination. Not every folder in the speaking engagements contains a speech. Her articles, some coauthored with F. E. Kelsey, reflect her involvement with research and pharmacology throughout her career. The book reviews, editorials, and the Queries and Minor Notes/Questions and Answers section pertain to Kelsey's years as an editorial associate for the Journal of the American Medical Association in Chicago during the 1950s. Files relating to Essentials of Pharmacology also appear in Part II with the arrangement of the background information still correlating to different chapters in the book. While again covering chapters 1 through 20, the files do not contain material for chapters 3, 4, 13, and 14. Additional files, however, include material for chapters 21 through 34. The appearance of later material in the background information indicates that Kelsey continued interfiling into it past the final publication of the book in 1960. It should be noted that many of the chapter topics also appear as topics in the Subject File .

The Subject File constitutes the largest amount of material in the papers and covers many of the same topics, persons, and organizations found in Part I: Research File and other series. Kelsey's files as director of the Division of Scientific Investigations at the FDA include the Bioresearch Monitoring Program, clinical evaluations, clinical investigations and investigators, drug laws and legislation, drug testing, FDA policies and regulations, fraud in science, good clinical practices, good laboratory practices, institutional review boards, investigational new drugs, methadone monitoring, new drug applications, radioactive drug research, teratology, and thalidomide. The historical material is comprised of files marked by Kelsey as "mostly historical," but also includes drug legislation, federal regulations, reminiscences about and articles by FDA personnel, clippings, and other material chronicling the history of the FDA. Under the heading of miscellany, the chronological material consists of unfiled correspondence and memoranda that may have been intended for the chronological file in the Office File . Clippings are comprised of unfiled articles probably intended for various topics located in the Subject File and in the Speeches and Writings File under Essentials of Pharmacology . The extensive files on thalidomide contain material dating from the 1960s to the 2000s and include correspondence, studies, articles, clippings, early press coverage of Kelsey, reports, inspections, exhibits, and legal case material including Kelsey's testimony and memorandum.

The F. E. Kelsey Files were compiled by Kelsey's husband while he worked at the National Institutes of Health in Washington, D.C., and as assistant to the surgeon general. Material under the heading of miscellany is comprised of unfiled items arranged chronologically. Some correspondence, writings, and other material related to F. E. Kelsey is located in the Personal File under the headings of South Dakota and University of Chicago.

Part II is rounded out by an Oversize series consisting of awards, certificates, citations, diplomas, card indexes, a menu, a map, memoranda, and a broadside. The Digital Files contain mostly Kelsey's memoranda to John Patrick Swann, drafts of her performance plans, and the 1995 annual report of the Office of Compliance. There is also a smattering of lists, speeches, notes, forms, article abstracts, correspondence, and writings by Aya Collins.