John Jennings, M.D. 
VICE PRESIDENT 
SCIENCE AND TECHNOLOGY 
Pharmaceutical 
Manufacturers 
Association 
September 3, 1987 
Dr. William T. Gartland 
Director, Office of Recombinant 
DNA Activities 
12441 Parklawn Drive 
Suite 58 
Rockville, Maryland 20852 
Dear Dr. Gartland: 
Re: Recombinant DNA Research; Proposed Actions Under 
Guidelines (NIH-RAC) . 
Federal Register Notice (Vol. 52, pp. 29800-29814, 
Doc. 87-18200, August 11, 1987) 
The Pharmaceutical Manufacturers Association ( PMA) is a volun- 
tary non-profit trade association representing over 100 companies 
engaged in research on, and the development, manufacturing and 
marketing of, prescription and ethically promoted drugs, biologicals 
and in vivo diagnostic products. Increasingly, these therapeutic and 
diagnostic products are created through biotechnological processes. 
We are, therefore, vitally interested in how biotechnology is 
addressed under national science policy and in regulatory decisions 
that affect research and development of biotechnology-derived 
products. Accordingly, we welcome this opportunity to comment on 
proposed changes in NIH recombinant DNA ( rDNA ) research guidelines. 
We have reviewed the proposed changes which provide very 
specific and detailed changes in the NIH Guidelines to cover research 
involving plants and animals . Although we believe the proposed 
guidelines are reasonable, we are nevertheless concerned by the 
shifting roles of Federal agencies vis-a-vis the use of plants and 
animals in pharmaceutical research and production. It is our 
intention to communicate similar views to the appropriate USDA 
officials and to establish an informal dialog with that agency. We 
would welcome the participation of representatives of NIH-RAC in 
subsequent discussion if that would be of benefit. 
1100 Fifteenth Street NW, Washington, DC 20005 • Tel: 202-835-3540 • TWX: 71 08229494-PMAWSH 
Sincerely 
[340] 
Recombinant DNA Research, Volume 13 
