Organized Collections
The Drug Efficacy Study of the National Research Council’s Division of Medical Sciences, 1966-1969
[The following description was adapted from former Division of Medical Sciences Chairman R. Keith Cannan’s history of the DES, published in the May 1968 NAS News Report]
The Drug Efficacy Study of the National Research Council’s Division of Medical Sciences, which was tasked with evaluating the medical effectiveness of 3,000-4,000 drugs introduced between 1938 and 1962, was undertaken in April 1966 at the request of the Food & Drug Administration (FDA) and its then-new Commissioner James L. Goddard. The stimulus to the study was the 1962 Kefauver-Harris Amendment to the Food Drug & Cosmetic Act of 1938. The Amendment required that in addition to being proven to be safe, drugs must be shown to be effective in regard to the therapeutic claims made for them.
Guidelines for the conduct of the study were developed by a Policy Advisory Committee (PAC), the membership of which derived from academic and professional medicine and its major specialties, as well as from pharmacology, industry, and medical sociology. The actual work of drug evaluation was assigned to 180 specialists assembled into thirty panels covering the main categories of drug applications. The panels sought evidence of drug efficacy from four main sources: 1) Briefs submitted by the sponsor of the drug; 2) additional evidence directly solicited from the sponsor; 3) the files of the FDA; and 4) pertinent medical literature brought in by the panelists. Each claim for a drug was subjected to a separate evaluation leading to a decision as to the drug’s efficacy, thus compelling the panels to make literally tens of thousands of such decisions. The panels then submitted the reports of their evaluations to the PAC, which in turn transmitted the reports to the FDA. A final report was issued by the DES in 1969; in addition, the panels’ reports were published verbatim in the Federal Register after they were received by the FDA.
The records of the Drug Efficacy Study contain correspondence, reports, meeting minutes, press clippings, and other records documenting the activities of the DES. The papers originated in the offices of the DES and the Division of Medical Sciences.
Span dates: 1963-1974
Bulk dates: 1966-1969
Volume: Approximately 3.5 linear feet
Series 1: DES
Series 2: DES PANELS
Series 3: DES POLICY ADVISORY COMMITTEE (PAC)
Series 4: DES REPORTS
Series 5: DES NAME FILES
Series 6: PRESS COVERAGE
FOLDER LIST
Ad hoc Committee on Drug Efficacy Review: Meeting: 20 Apr 1966
Agreement on Transmittal of New Drug Applications from FDA to NAS: 1966
Aid to FDA in Implementing Recommendations: 1967-1968
Beginning of Program: 1966
Categorization of Drugs: Aug 1966
Chronology: 1968
Committee on Drug Categorization: 1966
Conference on Guidelines: Assembly of Organizational Delegates: Proceedings: 1966
Conference on Guidelines: Report of Pharmaceutical Manufacturers Association (PMA): 1966
Conference on Guidelines: General: 1966
Conference on Guidelines for Drugs Ranked “Effective, But”: 5 Apr 1971
Contract: 1966-1968
Critiques of DES by Executive Secretaries: 1966-1968
“Drug Efficacy Study of the NAS-NRC”: Smith R G [History of DES]: 1968
End of Program: 1969
FDA Interim Index to Evaluations Published in Federal Register for NAS-NRC Reviewed Prescription Drugs: 1974
General Statements: 1967-1968
Guidelines: 1966
Guidelines: General: 1966-1967
Ineffective Drugs: Roster: 1972
Ineffective Drugs: Roster: 1969-1971
Information Exchanges: Veterinary Drug Study: 1966-1968
Information Releases by FDA: 1967-1968
Invitations to Panel Members to Testify in Legal Proceedings: 1970
Invitations to Panel Members to Testify in Legal Proceedings [US Vitamin v Finch]: 1969
Invitations to Panel Members to Testify in Legal Proceedings [Bentyl]: 1968
Meetings: Listings: 1966-1968
Memoranda to Executive Secretaries: 1966-1968
Memoranda to Panel Chairmen & Members: 1966-1968
Memoranda to Policy Advisory Committee (PAC): 1966-1968
Organizing Committee: 1966
Policies: Panel Members Testifying in Legal Proceedings: 1968
Problems: Clarification of “Effective But” Ranking: 1971-1972
Problems: Clarification of “Effective But” Ranking: Meeting: 5 Apr 1971
Problems: Clarification of “Effective But” Ranking: Memorandum to Panel Chairmen: Jan 1971
Problems: Legal Status of Package Inserts [Modell Editorial “FDA Censorship”]: 1967
Problems: Therapeutic Equivalence of Generic Drugs: 1967-1969
Progress Reports: 1966-1969
Reporting Forms: 1966
Retention of Records: 1967-1968
Special Statements: 1967-1968
Speeches on History & Work of DES by Cannan Gilman & Trexler: 1966-1968
Staff Meetings: 1966-1968
Structure: 1966-1969
General: 1972-1974
General: 1966-1970
Administrative Procedures: 1966-1967
Allergy: Meetings: 1966-1968
Allergy: Membership: 1966
Allergy: General: 1966-1969
Anesthesia: Membership: 1966
Anesthesia: General: 1966-1969
Anti-Infectives (I): 1966-1969
Anti-Infectives (II): Consultants: 1967
Anti-Infectives (II): General: 1966-1968
Anti-Infectives (III): Membership: 1966
Anti-Infectives (III): General: 1966-1969
Anti-Infectives (IV): 1966-1969
Anti-Infectives (V): 1966-1968
Anti-Infectives: Membership: 1966-1967
Antineoplastic: Membership: 1966
Antineoplastic: General: 1966-1968
Anti-Parasitic: Membership: 1966
Anti-Parasitic: General: 1966-1968
Cardiovascular (I): Membership: 1966-1967
Cardiovascular (I): General: 1966-1968
Cardiovascular (II): Membership: 1967
Cardiovascular (II): General: 1967-1969
Chairmen: Rosters: 1966-1968
Chairmen’s Meetings: First: 9 Sep 1966
Consultants: Surgery: 1967
Consultants: Urology: 1967-1969
Dentistry: Membership: 1966
Dentistry: General: 1966-1969
Dermatology (I): Membership: 1966-1969
Dermatology (I): General: 1966-1969
Dermatology (II): Membership: 1966-1967
Dermatology (II): General: 1966-1969
Dermatology (III): Membership: 1967
Dermatology (III): General: 1967-1969
Diagnostic Agents: Membership: 1966
Diagnostic Agents: General: 1966-1968
Endocrine Disturbances: Membership: 1966
Endocrine Disturbances: General: 1966-1968
Executive Secretaries: 1966-1968
Fluid & Electrolyte Imbalance: Membership: 1966-1967
Fluid & Electrolyte Imbalance: General: 1966-1968
Gastroenterology (I): Membership: 1966
Gastroenterology (I): General: 1966-1969
Gastroenterology (II): Membership: 1966-1967
Gastroenterology (II): General: 1966-1968
Hematology: Membership: 1966
Hematology: General: 1966-1969
Interviews with Chairmen: 1967
Meetings: Listings: 1966-1968
Membership: Comments on DES Experience: 1969
Membership: Comments on Topics for Final Report: 1969
Membership: Comments on Topics for Final Report: Excerpts: 1969
Membership: End of Term Letters: 1969
Membership: Nominations by Panel Chairmen: 1966
Membership: Nominations of Chairmen by Professional & Scientific Societies: 1966
Membership: Release of Names of Panel Members to Congress: 1968
Membership: General: 1966-1969
Metabolic: Membership: 1966
Metabolic: General: 1966-1968
Neurological: Membership: 1966-1967
Neurological: General: 1966-1969
Ophthalmology: Membership: 1966
Ophthalmology: General: 1966-1968
Psychiatric: Consultants: 1967-1968
Psychiatric: Membership: 1966-1967
Psychiatric: General: 1966-1971
Relief of Pain: Membership: 1966-1967
Relief of Pain: General: 1966-1968
Reproductive System: Membership: 1966
Reproductive System: General: 1966-1968
Respiratory Disturbances: Membership: 1966-1967
Respiratory Disturbances: General: 1966-1968
Rheumatic Diseases: Consultants: 1967
Rheumatic Diseases: Membership: 1966
Rheumatic Diseases: General: 1966-1969
Surgery: Establishment: 1967
Surgery: Membership: 1967-1968
Surgery: General: 1967-1969
General: 1966-1967
Series 3: DES POLICY ADVISORY COMMITTEE (PAC)
Executive Committee: Briefing for Pharmaceutical Manufacturers Association on Status of Drug Efficacy Study: 31 Oct 1967
Executive Committee: Meeting to Consider Classification of Anti-Infective Combination Drugs: 24 May 1968
Executive Committee: Meeting with Representatives of FDA: 30 Nov 1967
Meeting: Joint with Panel Chairmen: 17 May 1967
Meeting with FDA on Interpretation of DES Reports: 23 Jan 1969
Meetings: Fourth: 6 Mar 1969
Meetings: Third: 27 Mar 1968
Meetings: Second: 12 Jan 1967
Meetings: First [DES Meeting with Representatives of FDA]: 16 Dec 1966
Membership: Appointments: 1966-1968
Membership: General: 1966-1967
Resolution on Publications by Panel Members: 1968
General: 1966-1968
Categorization of Final Reports: 1968
Final: 1969
Final: Distribution: 1969
Final: Preparation: 1968-1969
Final: Transmittal to Panel Members: 1969
Final: General: 1968-1970
Reevaluation of Drugs Ranked “Effective But”: Allergy: 1971
Reevaluation of Drugs Ranked “Effective But”: Anesthesia: 1971
Reevaluation of Drugs Ranked “Effective But”: Anti-Infective: 1971
Reevaluation of Drugs Ranked “Effective But”: Antineoplastic: 1971
Reevaluation of Drugs Ranked “Effective But”: Antiparasitic: 1971
Reevaluation of Drugs Ranked “Effective But”: Cardiovascular: 1971
Reevaluation of Drugs Ranked “Effective But”: Dentistry: 1971
Reevaluation of Drugs Ranked “Effective But”: Fluid & Electrolyte Imbalance: 1971
Reevaluation of Drugs Ranked “Effective But”: Gastroenterologic: 1971
Reevaluation of Drugs Ranked “Effective But”: Hematologic: 1971
Reevaluation of Drugs Ranked “Effective But”: Metabolic: 1971
Reevaluation of Drugs Ranked “Effective But”: Neurological: 1971
Reevaluation of Drugs Ranked “Effective But”: Ophthalmologic: 1971
Reevaluation of Drugs Ranked “Effective But”: Relief of Pain: 1971
Reevaluation of Drugs Ranked “Effective But”: Reproductive System: 1971
Reevaluation of Drugs Ranked “Effective But”: Respiratory Disturbances: 1971
Reevaluation of Drugs Ranked “Effective But”: Rheumatic Diseases: 1971
Reevaluation of Drugs Ranked “Effective But”: Surgery: 1971
Reevaluation of Drugs Ranked “Effective But”: General: 1971
Release: 1967-1968
Submissions 1-6: 1968
Submissions 7-10: 1968
Submissions 11-15: 1968
Submissions 16-19: 1968
Submissions 20-25: 1968-1969
Summaries: 1968
White Papers: Anti-Infective Combinations: 1968-1969
General: 1967-1968
Cannan R K [Special Assistant to NAS President]: 1963-1968
De Haen P [Drugs in Use Index Card System]: 1964-1967
Gilman A [PAC Exec Com Member]: 1967-1968
Goddard J L [FDA Commissioner]: 1966-1968
Middleton W S [DES Chairman]: 1967-1968
Middleton W S [DES Chairman]: 1966
Middleton W S: Drug Research Board (DRB) Correspondence: 1965
Middleton W S: Drug Research Board (DRB) Correspondence: 1963-1964
Seevers M: 1967
Shirkey H C [PAC Member]: 1966-1969
Smith R G [FDA Liaison to NAS]: 1966-1968
Press Coverage: News Articles: 1969
Press Coverage: News Articles: 1968
Press Coverage: News Articles: 1966-1967
Press Coverage: General: 1967-1970