Drug Industry Antitrust Act, 87-1&2

of
Special Committee Advisory to
The Secretary of Health, Education, and Welfare
To Review the Policies, procedures, and Decisions of
The Division of Antibiotics and the New Drug Branch of

The Food and Drug Administration

A. Mission This Committee was appointed in June 1960 by the President of the National Academy of Sciences at the request of the Secretary of Health, Education, and Welfare. It was asked to review the policies and procedures used by the Food and Drug Administration in reaching decisions concerning the acceptance and certification of new drugs, including antibiotics, and the scientific soundness of the decisions made in recent years. The Committee was also invited to present such recommendations as it might consider desirable for the protection of the public health through the functions of the FDA.

B. Procedure The Committee met on 28 June to plan its activities and again on 8 September to discuss its findings and formulate its recommendations. In both meetings it had the assistance of representatives of the Secretary's office and the FDA, who cooperated by providing pertinent information and ans wering questions arising from the study. The necessary legal steps were taken to permit members unrestricted access to the FDA files. In addition, an extensive file of documents concerning the law and regulations, policies and procedures, staffing and organization, and other pertinent matters was forwarded to each member for background and reference. (A list of these documents is appended.)

It was at once apparent that the Committee could not hope in any reasonable per lod to examine all, or even a large proportion, of the thousands of voluminous applications for certifiable antibiotic preparations and new drugs. processed under the Federal Food, Drug, and Cosmetic Act in recent years. It was therefore decided that the members would select for detailed study a limited number of preparations which they considered to be of especial significance. In all, 29 applications were reviewed, covering 3 preparations of certifiable antibiotics, 14 of antibiotics classed as new drugs, and 12 of other new drugs.

C. Conclusions - While the proportion of decisions studied was necessarily small, the Committee believes its sampling to be sufficiently representative, particularly of preparations which have been the subject of some controversy, to provide a reasonable basis for conclusions as to the performance of the FDA staff in protecting the public health.

Taking into account the limitations of the FDA's authority, funds, and scientific personnel, the Committee found the decisions it reviewed acceptable, despite certain deficiencies in the quality and quantity of the data upon which they were based. It found no evidence of disregard for the public health, and noted that appropriate action had been taken when hazards were established by subsequent clinical experience.

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Nevertheless, the Committee concluded that certain weaknesses inherent in the existing law and current staffing and budgetary support hamper the FDA in its task of protecting the public health. Accordingly, it has addressed its recommendations primarily to the correction of these defects. The increasing rate at which medical research is expanding and new and powerful drugs are being developed 1s multiplying the number of potential hazards to be controlled. Therefore, the Committee believes it essential that these recommendations be acted upon with the least possible delay.

D. Recommendations

1. The FDA should be given statutory authority to require proof of

the efficacy, as well as the safety, of all new drugs. Treatment of a patient with an ineffective drug in place of an effective one may jeopardize his recovery. This is true even though the drug may not be intrinsically harmful, and even though the specific condition for which the drug is given may not be ordinarily regarded as 11fe-threatening.

The FDA should be given statutory authority to require manufacturers of new drugs to maintain records and submit reports of clinical experience and other relevant data, not only before but after the drug is released for sale, as requested by the Commissioner in his proposed Factory Inspection and Drug Amendments of 1960. Any evaluation of a new drug is subject to revision in the light of broader experience, and the FDA must be in a position to advise the profession and warn the public promptly whenever new hazards are revealed.

3. The FDA should be given statutory authority to apply certifica

tion procedures to all antimicrobial agents used in the prophylaxis and treatment of infectious diseases. The Committee sees no reason for limiting certification to those antibiotic preparations which happen to have come on the market prior to 1950, and further believes that all agents employed for equally serious conditions should be subject to equivalent measures of control.

4. The Committee recognizes the importance to the public health of

ensuring that all drugs are prepared under the highest standards of quality control. It therefore endorses the Commissioner's proposals in the Factory Inspection and Drug Amendments of 1960 to clarify and strengthen existing inspection authority, and to require that all drugs be manufactured and packaged under adequate controls.

5. The Committee believes that the information supplied to physicians

concerning drugs should be not only accurate, but also complete, and that the date of such information is essential to its proper evaluation. It therefore endorses the proposed amendments to present labeling requirements published by the Commissioner in the Federal Register for 22 July 1960.

6. 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.

7. 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.

9. 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. This
18 important not only to improve the methods available for
carrying out its respons ibilities to the public, but also as
aid in recruiting and retaining competent scientists on the staff.

10.

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 respons ibilities 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-
pons ibilities. 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

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