6.

7.

8.

9.

10.

The Committee considers that the advertising of pharmaceuticals requires more careful regulation than that of products unrelated to the prevention and cure of disease. It therefore recommends that careful study be given to the problem of coordinating the supervision of labeling, promotional material, and other advertising of drugs, now divided among several agencies of the Government, and to means of ensuring that all information concerning drugs conveyed to the profession and the public by whatever media be in conformity with scientific fact.

When a decision has been reached concerning an application, a statement should be prepared and incorporated in the file summarizing the conclusions, the names and opinions of those involved, and such other data as may be necessary to provide a concise record of the basis for the decision. This should be of great assistance in the administrative review of current actions and in the scientific review of the files in relation to subsequent applications, as well as when the advice of consultants is sought.

The staff members responsible for processing applications should be supported to the utmost in their efforts to obtain submission of truly dependable scientific information on the efficacy and safety of the products. The data initially submitted by the manufacturer are not always of sufficient quality and quantity to permit a sound decision as to the merits of the product.

This

The FDA should be strongly supported in its effort to maintain a
research program of high quality on the methodology and standardi-
zation of drug testing and related areas of basic science.
is important not only to improve the methods available for
carrying out its responsibilities to the public, but also as an
aid in recruiting and retaining competent scientists on the staff.

The Committee urges the Commissioner to seek such authorization as may be necessary to establish an advisory organization of scientific and technical experts as a recognized resource for advice on criteria, procedures, and policies for the execution of the responsibilities of the FDA.

11. It is recognized that these various recommendations cannot be
carried out without expanded resources, both of funds and of
personnel. The Committee also considers that the present re-
sources of the FDA are less than adequate to meet existing res-
ponsibilities. It therefore urges that the FDA be granted the
authority and funds required to employ and retain larger numbers
of highly qualified personnel and to support their activities,
and endorses the recommendations made to this end by the Citizens'
Advisory Committee in 1955.

Approved 27 September 1960

BACKGROUND MATERIAL FURNISHED BY FDA TO MEMBERS OF SPECIAL COMMITTEE

B.

C.

Organization, Division of Antibiotics (Exhibit B)

Organization, Antibiotics Branch, Bureau of Medicine (Exhibit C)

D. Antibiotics Regulation, Vol. I (Exhibit D)

2.

3.

Types of Decisions Involved in Establishing Antibiotic Regulations, 23 June 1960 (Certifiable Antibiotics only)

Memorandum, Background Information for the NAS Committee, 22 June 1960, from Dr. W. H. Kesseních, Medical Director, Bureau of Medicine, with attachments:

A. Federal Food, Drug, and Cosmetic Act

General Regulations for the Enforcement of the Federal Food, Drug, and Cosmetic Act

B.

E.

New Drug Regulations (Encl. 2)

4.

F.

Statement of George P. Larrick (Encl. 4)

Organization Chart of FDA and Bureau of Medicine (Encl. 5)

Memorandum, Background Information for the NAS Committee from Bureau of
Medicine, 28 June 1960

7.

8.

9.

Report of Citizens' Advisory Committee on FDA, dated June 1955

Pamphlet, "Protecting Consumers of Food, Drugs, Cosmetics", dated 15
October 1959

Report of Panel on Food Additives, dated 9 May 1960

10. "Factory Inspection and Drug Amendments of 1960" 1 July 1960, Bill and Amendment

Press release dated

Comments by the Secretary of Health, Education, and Welfare,
Arthur S. Flemming, on the Recommendations of the Special
Advisory Committee to Review the Policies, Procedures and
Decisions of the Division of Antibiotics and the New Drug
Branch of the Food and Drug Administration

Recommendation

1

Comments

I concur in this recommendation that FDA be given
statutory authority to require proof of the efficacy,
as well as the safety, of all new drugs. There are
now two significant concepts on the basis of which
the Food and Drug Administration does, in fact, require
a demonstration of the efficacy of new drugs before
applications are cleared, namely, (1) when the drug is
offered for the treatment of a life-threatening disease,
and (2) when the drug may have a definite potentiality
to do harm where we have to measure the good the drug
does against its possible hazards. But I agree that
the new drug procedures are not adequate to insure the
efficacy of drugs which are essentially innocuous. Com-
missioner George P. Larrick testified before the Senate
Subcommittee on Antitrust and Monopoly on June 3, 1960,
as follows: "We would endorse a proposal that the new
drug section of the Food, Drug, and Cosmetic Act require
a showing of efficacy as well as a showing of safety."

2

I concur in this recommendation that the Food and
Drug Administration be given statutory authority to
require manufacturers of drugs to maintain records
and submit reports of clinical experience, particularly

Recommendation

Comments

after the drug is released for sale.

Senate Bill 3815

3

introduced in the 86th Congress, 2d Session, specifically provides for such recordkeeping and reporting. The Department of Health, Education, and Welfare submitted this bill as a proposal to Congress to strengthen the Federal Food, Drug, and Cosmetic Act.

I concur in this recommendation that FDA be given
statutory authority to apply certification procedures to
all antimicrobial agents. The present law now provides
for certification for products composed wholly or partly
of any kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, or bacitracin or any derivative thereof.
Recommendation 3 would extend mandatory certification
procedures to all antimicrobial agents whether produced
by living microorganism or by any other means.

I concur in this recommendation that the inspection
authority be strengthened to require that all drugs

be manufactured and packaged under adequate controls.
S 3815, proposed by the Department of Health, Education,
and Welfare, specifically provides that drugs be pro-
duced under adequate controls and manufacturing proc-
essing, packaging and storing, or be deemed to be
adulterated within the meaning of the Act.

Recommendation

5

6

7

8

Comments

I concur in this recommendation that the information

supplied to physicians concerning drugs be accurate and
complete. The proposed revisions in the regulations
under Section 502(f)(1) as published in the Federal
Register for July 22, 1960 will aid--as far as the

Food, Drug, and Cosmetic Act will permit--in the con-
trol of false and misleading promotion of new drugs to the
medical profession.

The issue reflected in this recommendation is an

important one. I am asking that a careful study be made

of the organizational problems involved and, when this study has been completed, I will make recommendations to the President.

I concur in this recommendation that a concise record be
prepared for the file summarizing the basis on which
the decision is made to permit a new drug application
to become effective. I have asked Commissioner Larrick
to submit proposals to me as to what needs to be done
to carry out this recommendation.

I concur in this recommendation that the staff members

responsible for processing new drug applications be supported fully in their insistence that they receive complete and dependable scientific data to support new

drug applications. This Department is aware of its

enormous responsibility in the clearance of new