INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE
L. H. FOUNTAIN, North Carolina, Chairman

JOHN A. BLATNIK, Minnesota
TORBERT H. MACDONALD, Massachusetts
J. EDWARD ROUSH, Indiana
JOHN E. MOSS, California

FLORENCE P. DWYER, New Jersey
BILL STINSON, Washington

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

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

director, scientific division..

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

American Medical Association; accompanied by Paul R. M.

Donelan, attorney, legislative department--

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 -
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 vice
resident, 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_.

Letters, statements, etc., submitted for the record by-

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

tical Association:

Excerpt from comment of Dr. Edward G. Feldman (exhibit 5)__

Excerpt from President Kennedy's message to the Congress re

proposed national mental health program, February 5, 1963-

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

promazine...

Pago

244

221

266

308

253

245

246

248

249

Exhibit 4-Statement on the pharmacy and therapeutics com-

mittee.

251

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

for the treatment of schizophrenia, March 6, 1964-

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

tical Association..

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

Pharmaceutical Sciences, February 1963_-

Donelan, Paul R. M., attorney Legislative Department, American
Medical Association: Letter from F. J. L. Blasingame, M.D., exec-
utive vice president, American Medical Association, to Hon. L. H.
Fountain, July 13, 1964..

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

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

Ph. D...

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

of North Carolina:

254

241

263

256, 258

231, 233

256

Excerpt from statement of Austin Smith, M.D.

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

Excerpt from statement of Dr. Edward G. Feldmann_.

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

mental Relations Subcommittee: Excerpt from statement of

William S. Apple, Ph. D..

Gray, W. Donald, senior investigator, Intergovernmental Relations

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

Lehman, Director of Pharmacology, Food and Drug Administration,

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

257

188

III

Letters, statements, etc.-Continued

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

American Medical Association:

Evaluation of new drugs by the Council on Drugs:

1. Triparanol (Mer/29)

2. Enovid (Norethynodrel with Mestranol)

3. Chloramphenicol (Chloromycetin).

4. Chlorpromazine (Thorazine).

5. Halothane (Fluothane) --

Page

228

228

229

229

229

6. Metronidazole (Flagyl) _ _

229

Excerpt from a FDA ad hoc committee report re use of Enovid__

Larrick, George P., Commissioner of Food and Drugs, U.S. Depart-

ment of Health, Education, and Welfare:

228

213

Advisory Committee on Investigational Drugs___

Agreements between the Public Health Service and the Food and

Drug Administration--

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

Memorandum of understanding, FDA-PHS, June 1, 1963_

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

Memorandum of understanding, FDA-National Library of

Medicine, February 5, 1964- -

156

158

161

162

Biographical data of Joseph Francis Sadusk, Jr., A.B., M.D.

Brochure describing project RAPID, September 1963.

Expenditures by FDA for methodology research..

168

165

196

Food and Drug Administration requirements for additional
medical staff in the evaluation of drugs for human use_

Form-Registration of drug establishment, 1963..

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

28, 1964...

215

98

164

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 of

Medicine....

209

Percentage of medical officers who are specialists-

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____

210

168

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

Cosmetic Act:

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

errata

Parts 1.104 and 1.105-Labeling and advertising of drugs—

Extension of time for filing objections.

Extension of time for the filing of briefs...

Notice of hearing and order staying the effectiveness of

regulations...

Notice of proposed rulemaking..

Press release, February 13, 1963..

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.

38

39

Letters, statements, etc.-Continued

Larrick, George P., Commissioner of Food and Drugs-Continued

Regulations for the enforcement of the Federal Food, etc.-Continued

Part 130-New drugs-Continued

New drugs for investigational use-

Notice of proposal to amend....

Press release, August 9, 1962.

Press release re extension of time for filing com-

ments...

Regulations as adopted..

Press release, January 6, 1963.

Procedural and interpretative regulations-

Notice of proposal to revise.

Press release, February 13, 1963..

Regulations as adopted..

Press release, June 20, 1963...

Radioactive new drugs for investigational use: Order

exempting from general regulations pertaining to new

drugs..

Required records and reports-

Notice of proposed revision_.

Press release, February 28, 1964.-

Regulations as adopted....

Press release, May 27, 1964-

Part 132-Registration of producers of drugs-

Notice of proposed rulemaking-

Press release, February 13, 1963.

Regulations as adopted..

Press release, April 4, 1963_

Part 133 Drugs; current good manufacturing practice, in

ufacture, processing, packing, or holding-

Notice of proposed rulemaking--

Press release, February 15, 1963.

Regulations as adopted.

Press release, June 20, 1963-

Part 146.23-Antibiotic drugs for investigational use; order
for revision.

Statement-Background of the Food and Drug Administration
(with charts 1-32)_.

Summary covering the drug Chloramphenicol (Chloromycetin) -
Moss, Hon. John E., a Representative in Congress from the State of
California: Excerpt from statement of George P. Larrick....

Rankin, W. B., Food and Drugs: Excerpt from paper presented by Dr.

Arnold J. Lehman, Director of Pharmacology, Food and Drug

Administration, to the American Society of Experimental Biologists

in 1960...

Smith, Austin, M.D., president, Pharmaceutical Manufacturers As-

sociation:

Page

42

41

47

50

48

69

61

107

99, 106

138

137

143

140

124

99, 123

148

328

189

Statement

Supplementary statement.

Pharmaceutical Manufacturers Association statement on public
and private support of medical research__.

Smith, Dr. Ralph, Director, New Drug Division, Food and Drug Ad-
ministration: List of articles on drug testing published by mem-
bers of the Food and Drug Administration...

Excerpt from an article in the New Rochelle (N.Y.) Standard-
Star, April 7, 1962, re consumer judgment.

Excerpt from statement of George P. Larrick.

Government advisory and review bodies.--

308

308

356

302

274

311

189