Interagency Coordination in Drug Research and Regulations: Hearings ... - United States. Congress. Senate. Government Operations - Google Books

Books

[blocks in formation]

AGENCY COORDINATION STUDY

(PURSUANT TO S. RES. 27, 88TH CONG., AS AMENDED)

REVIEW OF COOPERATION ON DRUG POLICIES AMONG FOOD
AND DRUG ADMINISTRATION, NATIONAL INSTITUTES OF
HEALTH, VETERANS' ADMINISTRATION, AND OTHER AGENCIES

JUNE 19, 1963

PART 5

TESTIMONY AND EXHIBITS

(INCLUDING SUBSEQUENT 1963-1964 CORRESPONDENCE) ON:
(1) COMMISSION ON DRUG SAFETY; (2) PHARMACEUTICAL MANUFAC-
TURERS ASSOCIATION; (3) MEDICAL EDUCATION ON
DRUG THERAPY AND OTHER DRUG ISSUES

Printed for the use of the Committee on Government Operations

88-311

U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON: 1964

For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C., 20402 - Price $2.25

COMMITTEE ON GOVERNMENT OPERATIONS

JOHN L. MCCLELLAN, Arkansas, Chairman

[blocks in formation]

SUBCOMMITTEE ON REORGANIZATION AND INTERNATIONAL ORGANIZATIONS
HUBERT H. HUMPHREY, Minnesota, Chairman

JOHN L. MCCLELLAN, Arkansas
ERNEST GRUENING, Alaska
EDMUND S. MUSKIE, Maine
CLAIBORNE PELI, Rhode Island
ABRAHAM RIBICOFF, Connecticut

KARL E. MUNDT, South Dakota
JACOB K. JAVITS, New York

JAMES B. PEARSON, Kansas

JULIUS N. CAHN, Stuff Director
RODERICK KREGER, Minority Consultant
EMMA S. ABBOTT, Clerk
LOUISA R. PEARSON, Editor

II

CONTENTS-PART 5

Statements of—

HEARING OF JUNE 19, 1963

L. T. Coggeshall, M.D., vice president of the university, the Uni-

versity of Chicago and the Frederick H. Rawson professor of medi-

cine, the University of Chicago; Chairman, Commission on Drug

Austin Smith, M.D., president, Pharmaceutical

Accompanied by Dr. Theodore Klumpp, president, Winthrop

Leroy E. Burney, M.D., vice president for health sciences, Temple

University, representing the Greater Philadelphia Committee on

Medical-Pharmaceutical Sciences__

(Which appear within or adjacent to witness' testimony)

Relating to the Commission on Drug Safety:

247. Lowell T. Coggeshall, M.D.: Biographical summary

248. Lowell T. Coggeshall, M.D.: Statement prepared for subcom-

mittee hearing - -

249. Commission on Drug Safety: Biographical summaries of its mem-

bers, text of its charter, list of its subcommittees, an initial state-

ment by its chairman, and outline of June 1963 conference of

professional and scientific societies which it sponsored

250. Kefauver drug amendments: Views of Dr. Lowell T. Coggeshall

in 1960 on the occasion of receiving an award from the Pharmaceuti-

cal Manufacturers Association and in opposition to then pending

drug legislation____

251. Commission on Drug Safety: Followup letter to Senate sub-

committee by Lowell T. Coggeshall, M.D., on diverse matters:

Expenditures by the commission; personal views on Public Law

87-781; tabulation of drug industry grants to the University of

Chicago and background of commission staff.

Relating to the Pharmaceutical Manufacturers Association:

252. Austin Smith, M.D.: Summary of professional career.

253. Theodore G. Klumpp, M.D.: Summary of professional career

254. Austin Smith, M.D.: Statement prepared for subcommittee

255. Pharmaceutical Manufacturers Association:

"Prescription Drug Industry Fact Book".

256. Pharmaceutical Manufacturers Association: Testimony by Theo-

dore G. Klumpp, M.D., before a House appropriations subcommittee

as regards needs of the Food and Drug Administration_-_-

257. Theodore G. Klumpp, M.D.: Supplemental statement on pro-

posed salary schedule and working conditions for Food and Drug

Administration employees..

258. Drug advertising: Followup statement by Austin Smith, M.D..

259. Labeling claims: Internal memorandum from a Food and Drug

Administration medical reviewer, criticizing "laxity" by the agency

and "ignoring" of its requests for re-labeling

260. Drug labeling: Views of another medical officer, Food and Drug

Administration, on a company's alleged obstructive tactics in re-

labeling a drug-

261. A 1962 letter from Winthrop Laboratories which had not been

acknowledged for a year: Followup comments by Food and Drug

Administration...

Relating to medical education and drug therapy:

262. Leroy Burney, M.D.: Biographical summary..

263. Leroy Burney, M.D.: Statement prepared for subcommittee

264. Leroy Burney, M.D.: Text of supplemental statement, urging

release of much now secret information on New Drug Applications,

describing adverse reaction reporting in the Philadelphia area and

suggesting more advisory counsel to FDA..

SUPPLEMENTARY EXHIBITS

TESTING AND EVALUATION OF DRUGS; MEDICAL EDUCATION AND

INFORMATION ON DRUG THERAPY; SPECIFIC DRUGS; INTERAGENCY

COORDINATION; Food and DRUG ADMINISTRATION; WORK OF THE

SENATE SUBCOMMITTEE AND ADDITIONAL VIEWS IN THE LITERA-

TURE ON DIVERSE DRUG POLICIES

SUBCOMMITTEE CORRESPONDENCE

(THROUGH APRIL 1964),

TOGETHER WITH BACKGROUND DOCUMENTS AND INFORMATION

(Which appear after witness' testimony)

On the testing and evaluation of drugs:

265. Drug testing and evaluation: Letters from physicians and other

scientists on needs, problems and opportunities in assuring the

highest standards of preclinical and clinical testing and

266. Drug testing and evaluation: Diverse phases of the issue of

efficacy-scientists' comments as to efficacy claims of "sus-

tained release" drugs; "in vitro" testing; as to the value of

"clinical experience;" previous lack of attention to the "placebo

effect," the need for controlled clinical trials and related

267. Drug testing and evaluation: Questioning, disputing, or adver-

tising of efficacy claims for specific new drugs-compendium

of quotations from American Medical Association sources.

268. Drug testing and evaluation: The issue of efficacy-articles in

the open literature based on controlled studies of tranquilizers,

disputing claims based on uncontrolled clinical trials...

269. Drug testing and evaluation: Efficacy and other requirements

under Public Law 87-781-draft regulations proposed by

Food and Drug Administration on February 28, 1964 and

comments on the regulations by the Pharmaceutical Manu-

facturers Association and the Proprietary Association..............

270. Drug efficacy: Correspondence inviting views on arthritis drugs,

together with background article...

271. Drug testing and evaluation: Correspondence on plan for use

by Food and Drug Administration of its authority, commenc-

ing October 1964, to evaluate efficacy of drugs, previously

cleared only as to safety. -

272. Rigged research: Reply by National Institutes of Health on a

grantee who had conceded falsification of a private test report,

together with information from the Food and Drug Adminis-

tration on 19 doctors under suspicion and other materials on

possible testing fraud including a letter from the Attorney

General of the United States..

273. Drug testing and evaluation: Possible effects on scientific

objectivity because of payment of fees by drug companies to

private clinicians-views of various sources..

274. Drug testing and evaluation: Possible effects on scientific

objectivity by clinicians' ownership of stocks in pharmaceutical

companies and other forms of alleged "financial involvements"

which might cause a conflict of interest..

275. Drug testing and evaluation: The issue of adequate training and

facilities for clinical pharmacology-

276. Drug testing and evaluation: The issue of patient consent to

serve as a subject of an experimental drug...

On medical education and information on drug therapy:

277. Information on adverse drug reactions: Views of practicing

physicians, U.S. Department of Defense, American Hospital

Association and other sources on reporting and evaluation of

278. Adverse drug reactions: Comments on potential further contri-

butions by toxicology and pathology toward identification of

otherwise "buried" drug effects.---

279. Drug information: Day-to-day needs and problems of the medical

practitioner-comments on advantages and disadvantages of

reference tools such as package inserts, Physicians' Desk

Reference, direct mail, together with other background

280. Drug information for practitioners: Drug detailing-

281. Drug information: The asserted confidentiality of the total con-

tents of files on New Drug Applications-the controversy over

what constitutes "trade secrets," together with related com-

ment as to questionable secrecy on pesticides... -

282. Drug information: Communication of news on "miracle" and

other drugs by press, radio, and television to the general public.

283. Medical education and drug research: Views of two sources.

284. Medical journals and drug communication: Views of a medical

editor, a medical professor, a Senate subcommittee, an official

of the National Better Business Bureau and FDA..........

285. Drug advertising in medical journals-comments by various

On specific drugs:

286. Aralen (chloroquine phosphate): Information on adverse reac-

287. Ostamer (a polyurethane polymer): Chronology on New Drug

Application subsequently withdrawn, together with other

materials, including adverse views of a Committee of the

American Academy of Orthopedic Surgeons-

288. Parnate (tranylcypromine): Information on clinical studies and

on adverse reactions prior and subsequent to its February 1964

withdrawal from the market, together with data on related

psychopharmacologicals.

289. Valium (Diazepam): Medical controversy over investigator's

claims of an allegedly "dramatic breakthrough" in treatment

for cerebral palsy and athetosis_

290. Efocaine: Excerpts from private sources prior to and following

withdrawal of the drug from the market without notification to

the Food and Drug Administration__

291. Orabilex (bunamiodyl sodium): Additional information regarding

its history prior to and following withdrawal from the market..

292. MER/29 (triparanol): Excerpts from the FDA New Drug Ap-

plication file in 1959-1961, together with 1964 comments on

pleas of nolo contendere to criminal indictments..

293. Regimen: Background information to criminal indictment on an

over-the-counter drug--

On interagency coordination:

294. Medical devices: Interagency coordination in evaluation, pro-

curement and dissemination of information as to safety and

295. U.S. Department of Agriculture: Relationships with Food and

Drug Administration under Insecticide, Fungicide, and Ro-

denticide Act...

296. U.S. Department of Agriculture: Its review of chemical applica-

tions for diaper rinses-an illustration of an area of overlapping

interest with the Food and Drug Administration...

« Previous Continue »