MEMORANDUM 
TO 
FROM : 
SUBJECT: 
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
Director, NIH 
DATE: June 4, 1976 
Associate Director for 
Program Planning and Evaluation 
Summary of Your Meeting with Private Industry, June 2 
The following points, noted here for the record, emerged from your meeting 
with representatives of private industry on the NIH guidelines for recom- 
binant DNA research. 
The industry representatives were pleased that their views were being 
considered and that they were being informed about the NIH guidelines. 
As Dr. John G. Adams, Vice President, Scientific and Professional 
Relations, Pharmaceutical Manufacturers Association, pointed out, this 
was the first opportunity for industry to meet and discuss this important 
research area. 
Generally, the industry representatives were receptive in reviewing the 
guidelines as they might apply to industrial research. They noted, 
however, that a number of important areas of interest to industry would 
have to be taken into account. In the proposed guidelines, for example, 
there was a prohibition of producing more than 10 liters of culture unless 
approved by the Recombinant Advisory Committee; and while this may be 
large for purposes of research at a university, it indeed could be quite 
small for purposes of industrial production. 
Further, the guidelines are primarily concerned with pathogens, and the 
representative from General Electric believed attention should be given 
to nonpathogens that might be more commonly used in industry. Others 
suggested that analogs to the EK system of containment might indeed be 
appropriate for industrial use. And an overriding consideration for 
industry was the need to protect patent rights and prevent premature 
disclosure of research. Thus, for example, the companies might be 
willing to list investigators and the research labs in a voluntary 
registery, but might be quite reluctant to list the actual research 
that is ongoing. 
In view of these considerations. Dr. Adams suggested that he explore 
with other drug industry representatives the formation of a committee 
to evaluate the NIH guidelines. If appropriate, the group might 
determine how the guidelines could be made applicable to industry in 
light of the special considerations raised at the meeting, and might 
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