PHARMACEUTI C A L 
JOHN JENNINGS, M. D. 
VICE PRESIDENT 
SCIENCE AND TECHNOLOGY 
MANUFAO 1>W R E R 3 
IIOO FIFTEENTH STREET, N.W. 
WASHINGTON, D. C. 20005 
AREA CODE (202) 835-3540 
CABLE - PHAR M/WASHI NO TON, O C 
TWX- 7 1 0822 9494- PMA WSM 
February 1, 1984 
Director 
Office of Recombinant 
DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda , MD 20205 
RE: Proposal Entitled "Recombinant DNA Research; Proposed 
Actions Under Guidelines" Appearing in the January 5, 1984, 
Federal Register 
Dear Sir: 
The Pharmaceutical Manufacturers Association is a voluntary 
non-profit association composed of 130 companies engaged in the 
development, manufacture, and marketing of prescription and 
ethically promoted pharmaceuticals, medical devices, and diag- 
nostic products. Many of our member firms use recombinant DNA 
technology in the research, development, and production of 
products intended for the diagnosis, prevention, and treatment of 
disease in human beings and, therefore, would be affected by the 
"Proposeod Actions Under Guidelines." Therefore, we offer the 
following comments for the consideration of the Office and the 
Recombinant DNA Advisory Committee (RAC) . We will confine our 
comments to questions contained under item II "Questions Con- 
cerning Boundaries for NIH and RAC Oversight." 
Representatives of our member firms have regularly attended 
and participated in RAC meetings, have suggested various modifi- 
cations to the guidelines, and have commented on the suggestions 
of others. Together and severally, we have been aware of the 
various issues of potential risk, environmental effects, public 
awareness and concern. Congressional interest, and legislative 
proposals. Our comments are based on this continuing experience 
with the RAC and our appreciation of its demonstrated ability to 
assess and resolve complex scientific problems. Over the years, 
the Committee has helped to establish a reservoir of expertise 
and experience among its members, advisors, and consultants that 
is invaluable in consideration of the diverse scientific and 
technical questions raised by research in recombinant DNA tech- 
nology. We have been especially gratified by the willingness of 
the Committee to consider the concerns and points of view of 
various sectors of the scientific community and the general 
publ ic . 
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