SUPIITIE OF THE
0017

ITTEE ON COTIKTINT OPERATIONS EOTO OF HERITATIVAS

STIILSED CONGESS

TESSION

SUBCOMMITTEE OF THE

COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES

EIGHTY EIGHTH CONGRESS

SECOND SESSION

HABCH 24, 25, APRIL & AND JUNE 14

Printed for the one of the
Committee on Government Operations

OL GOVERNMENT PRINTINO OTTO

WASHINGTON : 194

COMMOTTH ON GOVERNMENT OPERATIONS

WILLIAM L DAWSON, Minota, Cheras CRET HOLIPIELD, Callusta

R. WALTER RIEHLMAN, New Yo JACK BROOKS, Town

GEORGE MEADER, Mladet L .. FOUNTAIN, North Carolitas

CLARENCE I. BROWN, ONO PORTER HARDY, JR., Virginia

FLORENCE P. DWYIL, Now dow JOEN A. BLATNIK, Manucota

ROBERT P. GRIETIN, Mlatterin ROBERT E. JONEB, Alabama

GEORGE M. WALLHAUSER, NO Soreng EDWARD A. GARMATZ, Maryland

JOHN B. ANDERBON, Maste JOEN E. MOB8, California

OGDEN R. REID, Now Yat DANTE B. FABCELL, Merida

FRANK J. BORTON, Nor Yu HENRY 8. REUSB, Wimaneta

BILL STINSON, Wrohington JOHN 6. MONAGAN, Connecticut

ROBERT MCCLOBY, Itacte
RICHARD E. LANKFORD, Maryland

IRENE B. BALER, Thane
TORBERT H. MACDONALD, Mondboontle
J. EDWARD ROUSH, Indian
WILLIAM 8. MOORHEAD, Ponpoginuo
CORNELIUS E. GALLAGHER, New Songs
WILLIAM J. RANDALL, Moves
BENJAMIN 8. ROSENTHAL, New York

CITING RAT Dam, ea Dinu

JAYA A. LANIOAN, General Cound
Han Q. ROMNBT, Associate General Ommed

3. P. Canson, Minority Cound
Lithout T. COLLama, Mimenty Pratcotoned that

INTERGOVERNMENTAL RELATIONI Suncovca.

L. E. FOUNTAIN, North Carolina, Alainan JOEIN A. BLATNIK, Minnesota

FLORENCE P. DWYER,

Now
TORBERT H. MACDONALD, Mannchuettu BILL STINSON, Washington
J. EDWARD ROC8A, Indians
JOIN E. MO88, California

Dam C. GOLDBRG, Professional das Manter

JAYD R. NAUGHTON, Counad
W. DONALD GUAT, Senior kunatimeter
GBORGB O. Bnm, Ancient Commed

CONTENTS

Statement of

Apple, William S., Ph. D., executive director, American Pharmaceu-

tical Association; accompanied by Edward G. Feldmann, Ph. D.,

director, scientific division..

244

Hussey, Hugh H., M.D., director, Division of Scientific Activities,

American Medical Association; accompanied by Paul R. M.

Donelan, attorney, legislative department..

221

Larrick, George P., Commissioner of Food and Drugs; accompanied

by Dr. Ralph Smith, William W. Goodrich, W. B. Rankin, and

M. D. Kinslow..

Smith, Austin, M.D., president, Pharmaceutical Manufacturers Asso

ciation;

accompanied by Leonard Scheele, M.D., senior vice presi

dent, Warner-Lambert Pharmaceutical 'Co.; and Theodore G.
Klumpp, M.D., president, Winthrop Laboratories..

206
Smith, Austin, M.D.,

president, Pharmaceutical Manufacturers Asso-

ciation; accompanied by Theodore G. Klumpp, M.D., president,

Winthrop Laboratories; Leonard A. Scheele, M.D., senior vico

president, Warner-Lambert Pharmaceutical Co.; Karl H. Beyer,

M.D., vice president, Merck Sharp & Dohme Research Laborato

ries; C. Joseph Statler, executive vice president and general counsel,

Pharmaceutical Manufacturers Association; and Karl Bambach,

Ph. D., senior vice president, Pharmaceutical Manufacturers Associ.

ation..

208

Letters, statements, etc.,

submitted for the record by-

Apple, William 8., Ph. D., executive director, American Pharmaceu-

tical Association:

Excerpt from comment of Dr. Edward G. Feldman (exbibit 5).. 253

Excerpt from President Kennedy's message to the Congress ro

proposed national mental health program, February 5, 1963. 245

Exhibit 1-Prescribing information, thorazine, brand of chlor-

promazine.

248

Exhibit 2-Press release from U.S. Public Health Service re drugo

for the treatment of schizophrenia, March 6, 1964.

248

Exhibit 3-Editorial by Don E. Francke, American Pharmaceu-

tical Association...

249

Exbibit 4Statement on the pharmacy and therapeutics com-

mittee.

251

Exhibit 5-Editorial by Edward G. Feldmann, in Journal of

Pharmaceutical Sciences, February 1963.-

254

Donelan, Paul R. M., attorney Legislative Department, American

Medical Association Letter from 8. J. L. Blasingame, M.D., exeo-
utive vice president, American Medical Association, to Hon. L. H.

Fountain, July 13, 1964..

Dwyer, Hon. Florence P., & Representative in Congress from the

State of New Jersey: Excerpt from statement of William 8. Apple,

Ph. D..

263

Fountain, Hon. L. H., a Representative in Congress from the State

of North Carolina:

Excerpt from statement of Austin Smith, M.D..

256, 258

Excerpt from statement of Hugh H. Hussey, M.D.

231, 233

Excerpt from statement of Dr. Edward G. Feldmann..

256

Goldberg, Dr. Delphis C., professional staff member, Intergovern

mental Relations Subcommittee: Excerpt from statement of

William S. Apple, Ph. D...

257

Gray, W. Donald, senior investigator, Intergovernmental Relations

Subcommittee: Excerpt from paper presented by Dr. Arnold J.

Lehman, Director of Pharmacologs, Food and Drug Administration,

to the American Society of Experimental Biologists in 1960....

188

241

CONTENTO

Letters, statements, etc.- Continued

Hussey, Hugh H., M.D., director, Division of Scientifio Activities,

American Medical Association:

Evaluation of new drugs by the Council on Drugs:

1. Triparanol (Mer/29)..

2. Epovid (Norethynodrel with Mestrapol).-

3. Chloramphenicol (Chloromycetin).-....

4. Chlorpromazine (Thorazine).

5. Halotbane (Fluothane)..

6. Metronidazole (Flagyl).

Excerpt from a FDA ad hoc committee report re use of Enovid..

Larrick, George P.,

Commissioner of Food and Drugs, U.8. Depest

ment of Health, "Education, and Welfare:

Advisory Committee on Investigational Drugs.....

213

Agreements between the Public Health Service and the Food and

Drug Administration

Memorandum of understanding, FDA-NIH, May 1, 1963.. 158

Memorandum of understanding, FDA-PHS, June 1, 1963.. 158

Memorandum of understanding, FDA-PHS, July 5, 1963.. 161

Memorandum of understanding, FDA-National Library of

Medicine, February 5, 1964.

10

Biographical data of Joseph Francis Sadusk, Jr., A.B., M.D. 18
Brochure describing project RAPID, September 1963.

165
Expenditures by FDA for methodology research...

196

Food and Drug Administration requirements for additional

medical staff in the evaluation of drugs for human use...

215

Form- Registration of drug establishment, 1963-

98

Letter from George P. Larrick, to Hon. L. H. Fountain, May

28, 1964...

161

The Food and Drug Administration's adverse reaction

reporting program.:

164

National Advisory Council to the Food and Drug Administra

tion...

214

Organization chart-Office of the Commissioner, Bureau o

Medicine.

209

Percentage of medical officers who are specialists..

210

Press release announcing appointment of Joseph Francis Sadusk,

Jr., A.B., M.D., as Director of the Bureau of Medicine of the

Food and Drug Administration....

168

Regulations for the enforcement of the Federal Food, Drug, and

Cosmetic Act:

Parts 1, 130, 132, 133—Proposed regulations regarding drugs,

errata..

65

Parts 1.104 and 1.105 Labeling and advertising of drugo
Extension of time for filing objections..

120
Extension of time for the filing of briefs...

133, 134

Notice of hearing and order staying the effectiveness of

regulations...

129

Notice of proposed rulemaking-

66

Press release, February 13, 1963.

61

Order on objections to regulations.

132

Press release, October 21, 1963.

130

Order for adoption of regulations, as amended.

101
Press release, June 20, 1963.

99, 100
Regulations as adopted..

135
Press release, January 18, 1964.

134

Part 130_New drugs-

Changes in drug labeling requirement; changes in new

drug applications.

33

Changes in drug labeling requirement; changes in new

drug applications; amendment in final order and

changes in effective date...

39

Press release, January 11, 1961.

39