PHARMACEUTICAL 
C • JOSEPH S T ETLE ^ 
£$3 D k. r J T 
M AN U FACTl/RE RS 
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1155 FIFTEENTH STREET. N.W 
WASHINGTON. D. C. 20005 
ARCA CODE 20a - 2S-S -2aa O 
November 2, 1976 
Donald S. Fredrickson, M. D. 
Director 
National Institutes of Health 
Public Health Service 
Department of Health, Education, and Welfare 
Bethesda, Md. 
Dear Doctor Fredrickson: 
The following comments are provided in response to the notice published 
on July 7, 197.6, FR (41) 131 entitled "Recombinant DNA Research - 
Guidelines" by the Department of Health, Education, and Welfare. 
As you know, the Pharmaceutical Manufacturers Association presented 
testimony before the Health Subcommittee of the Senate Labor and Public 
Welfare Committee on September 22, 1976. A copy of that testimony is 
enclosed. Also enclosed is a copy of our letter, dated September 29, 1976, 
in response to your request of September 7, 1976, for comments cn patent 
policy considerations pertinent to government sponsorship of recombinant 
DNA research. 
The general purpose of this letter is to reiterate our statement that PMA 
member firms support the spirit and intent of the Guidelines. As noted in 
our testimony, we believe that in the case of non-government supported 
research some modification will be necessary regarding (1 ) protection of 
intellectual property rights and (2) volume restrictions. It is our con- 
sidered opinion that such modification can be achieved without harm to the 
purpose or effectiveness of the Guidelines. Such modification should be 
general rather than specific, and should provide for negotiations between 
non-government supported sponsors of such research and appropriate offi- 
cials of your office. 
[152] 
Representing manufacturers of prescription pharmeceuticals. 
medical devices and diagnostic products 
