Alexander M. Schmidt Papers

COLLECTION FINDING AID

ALEXANDER M. SCHMIDT PAPERS, 1967-90

Chief, Education and Training Branch, Regional Medical Programs, National Institutes of Health;
Commissioner of Food and Drugs;
Academia

CONTENTS

Summary Description | Biographical Information | Series Descriptions | Container List

SUMMARY DESCRIPTION

The collection contains materials relating primarily to the administration of food and drug regulatory policy in the United States on such topics as the drug approval process; the introduction of new drugs into the marketplace; over-the-counter drugs and self-medication; new treatments and therapies for cancer, stroke, diabetes, and influenza; food safety; and food additives and additives in veterinary food products.

QUANTITY
48.1 linear feet (approximately 85,400 pages)

DONOR
Patricia W. Schmidt (94-NLF-042 and 97-NLF-009)

ACCESS
Open. Researchers wishing to view papers should consult with an archivist prior to their visit in order to request that specific folders be added to the Library’s review-on-request queue. Even after the completion of this review some items may be temporarily restricted under terms of the donor's deed of gift, a copy of which is available on request, or under National Archives and Records Administration general restrictions (36 CFR 1256).

COPYRIGHT
Patricia W. Schmidt donated to the United States of America copyrights in all of her late husband’s unpublished writings in National Archives collection. The copyrights to materials written by other individuals or organizations are presumed to remain with them. Works prepared by U.S. Government employees as part of their official duties are in the public domain.

Prepared by James Neel, 8/16/2017
[s:\bin\findaid\schmidt, alexander - papers.doc]

BIOGRAPHICAL INFORMATION

Alexander MacKay Schmidt, M.D.

January 26, 1930 - Born, Jamestown, North Dakota

1951 - B.S., Northwestern University

1955 - M.D., University of Utah

1955-56 - Intern, University of Utah College of Medicine Affiliated Hospitals

1956-58 - United States Army

1958-60 - Resident, University of Utah College of Medicine Affiliated Hospitals

1960-62 - Public Health Service Research Fellowship in Cardiology, University of Utah College of Medicine

1962-64 - Instructor, University of Utah College of Medicine

1962-68 - Director, University of Utah College of Medicine Cardiovascular Laboratory

1964-68 - Assistant Professor, University of Utah College of Medicine

1966-67 - Director of Planning, University of Utah Cardiovascular Research and Training Center

1967-68 - Assistant Dean, University of Utah College of Medicine

1967-68 - Chief, Education and Training Branch, Regional Medical Programs, National Institutes of Health, Department of Health, Education and Welfare, Washington, D.C.

1969-70 - Executive Associate Dean and Associate Professor of Medicine, University of Illinois College of Medicine

1970-73 - Dean and Professor of Medicine, Abraham Lincoln College of Medicine, University of Illinois College of Medicine

1973-76 - Commissioner of Food and Drugs, Food and Drug Administration (FDA), Department of Health, Education and Welfare, Washington, D.C.

1977-87 - Vice Chancellor for Health Services, Academic Affairs, and Health Affairs, University of Illinois

1987-88 - Professor of Health Policy and Social Medicine, Institute of Government & Public Affairs, University of Illinois

1988-89 - Vice President and Director, Technical Advancement Center, University Hospital Consortium

January 28, 1991 - Died, Oak Park, Illinois

INTRODUCTION

Dr. Alexander M. Schmidt began his career in medicine at the University of Utah College of Medicine, where he held several academic positions. He first entered government service in 1967 as Chief of the Education and Training Branch in the Regional Medical Programs (RMP) at the National Institutes of Health. The RMP, created during the Johnson Administration as a “Great Society” project, promoted cooperative efforts in making the latest biomedical research available throughout the United States, especially relating to cardiovascular disease, stroke, and cancer. Schmidt oversaw the education and training efforts of the program, and assisted with grant writing efforts for medical research. When his tenure at RMP ended in 1968, Schmidt returned to academia at the University of Illinois’ College of Medicine and the Abraham Lincoln College of Medicine.

In 1973, President Richard Nixon appointed Alexander Schmidt as Commissioner of Food and Drugs to head the Food and Drug Administration (FDA). Schmidt inherited an agency undergoing a major reorganization begun by his predecessor, and mired in controversy brought about by a group of federal employees within the FDA who had lodged several complaints with Congress concerning agency operations and policies. As a result, Schmidt and several of his deputies were immediately immersed in Congressional hearings about the complaints and internal investigations conducted by FDA concerning the complaints.

During Schmidt’s tenure, the FDA resolved or made progress on a number of important food and drug issues. The FDA streamlined the drug approval process; began valuable conversations about patient package inserts for prescription drugs; initiated the first reviews of over-the-counter drugs and self-medication; answered President Ford’s call for regulatory reform, while maintaining safe reviews for new drug applications; and pushed back on accusations from private industry that the FDA continually caused a drug lag in its approval process. Throughout his tenure, Schmidt endeavored to strengthen the bonds between the FDA and the agency’s regional offices throughout the United States. He also reached out to the food and drug enforcement agencies in England and Japan to foster communication and mutual assistance.

Despite a sometimes adversarial relationship, Congress and the FDA worked together to pass the Medical Device Amendments of 1976, signed by President Ford on May 28, 1976, which amended the Food, Drug, and Cosmetics Act of 1938.

At the end of the Ford administration, Schmidt resigned from FDA and returned to academic administration and teaching at the University of Illinois.

Scope and Content of the Schmidt Papers
This collection consists of the personal papers of physician and academic Alexander Schmidt. The bulk of these papers document Schmidt’s time at the FDA in his role as the Commissioner of Food and Drugs. Included within this collection are hundreds of letters and memoranda to and from Schmidt, thousands of pages of administrative documents associated with the daily operations and ongoing projects of the agency, and several editions of the FDA Clipping Service circular and the FDA Consumer magazine.

The collection also contains materials from Schmidt’s time at RMP within the National Institutes of Health (NIH) during the late 1960’s and his career in academia when not in government service. As with the FDA materials there are hundreds of pages of correspondence, as well as books, scholarly articles, theses, dissertations, and research papers written by Schmidt’s contemporaries, as well as drafts of his own scholarly writings. There are also briefing books, memoranda, letters, and agenda of the several committees and boards in which Schmidt took part, either as a member or in an advisory role; there are court documents associated with litigation on decisions that FDA or other agencies and organizations made with reference to food and drugs. The collection also contains newspaper clippings and articles having to do with a wide variety of medical issues, as well as publications that were compiled that have articles associated with Schmidt, the FDA, or both.

There have been 48 bound volumes transferred out of the collection to the Ford Library Book Collection. A bibliography of titles is available in Box 93, folder titled, “Transfers to the Book Collection.” The collection does not include materials related to Schmidt’s positions in academia at the University of Utah prior to 1967.

Related Materials (August 2016)
Significant materials on the Food and Drug Administration (FDA) are located in various sub-categories within White House Central Files (WHCF) Subject File categories FG (Federal Government Organizations/Units) and HE (Health). Related materials also appear in the staff files of the White House Domestic Council and the White House Congressional Relations Office. Please consult with an archivist to obtain a PRESNET search report listing the folders on any of the topics.

SERIES DESCRIPTIONS

General Subject File, 1967-90. (Boxes 1-96, 42 linear feet)
Memoranda, correspondence, reports, notes, press releases, manuals, pamphlets, periodicals, and clippings containing information on the drug approval process, drug safety, efficacy of approved drugs, food safety, and food and drug litigation compiled during his career at the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and in academia. Other topics include human subject research, drug and food labeling, self-medication, and carcinogenicity of food and drugs.

Arranged alphabetically by subject.

View container list for this series

Speech and Conference File, 1967-90. (Boxes 97-107, 4.8 linear feet)
Memoranda, correspondence, press releases, speech drafts, reading copies of speeches, travel documents and receipts, and brochures pertaining primarily to Alexander Schmidt’s speeches on a variety of food and drug-related issues before governmental and private interest groups during his career in the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and in academia. Also included are files for meetings and conferences attended by Schmidt when not making a speech.

Arranged chronologically by date of event and alphabetically thereunder.

View container list for this series

Printed Material, 1972-85. (Boxes 108-110, 1.3 linear feet)
Journals, magazines, and newspapers containing interviews or articles associated with food and drug regulatory policy; the Food and Drug Administration; and the Department of Health, Education, and Welfare, or its successor organization, the Department of Health and Human Services.

Arranged alphabetically by publication title.

View container list for this series

CONTAINER LIST

Box 1 - General Subject File