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

Location: NAS 234 B-3-1 & 2

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

Series 1: DES

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

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Series 2: DES PANELS

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

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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

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Series 4: DES REPORTS

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

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Series 5: DES NAME FILES

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

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Series 6: PRESS COVERAGE

Press Coverage: News Articles: 1969

Press Coverage: News Articles: 1968

Press Coverage: News Articles: 1966-1967

Press Coverage: General: 1967-1970

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