PHARMACEUTI CAL MAN U FA 
BRUCE J. BRENNAN 
VICE PRESIDENT AND GENERAL COUNSEL 
1155 FIFTEENTH STREET, N. W. 
WASHI NGTON, D. C. 20005 
AREA CODE 202-296-2440 
September 25, 1978 
Donald S. Fredrickson, M.D. 
Director 
National Institutes of Health 
Department of Health, Education and Welfare 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
This letter is in response to your request for comments on the 
proposed Revised Guidelines for Recombinant DNA Research, published 
in the Federal Register of July 28, 1978, (43 FR 33043). 
The PMA and its member companies are pleased to note that the 
revised guidelines reflect a reasonable approach to Recombinant DNA Research 
and a further improvement of previous guidelines. 
We support the added flexibility provided for in the guidelines. 
Particularly, we are pleased to note (1) the increased importance of 
institutional authority, (2) the mechanisms for lowering containment levels 
as experience is gained and (3) the exemptions provided for in the proposal. 
In addition, the following specific comments and recommendations 
on the revised guidelines are offered for your consideration. 
Sections IV-C-3&4 do not offer an adequate system for protection 
of patentable subject matter and other proprietary rights. For example, 
the suggestion that patents be applied for prior to disclosure to the NIH 
of experimental outlines is an impractical and unreasonable approach. 
There should be a more effective means for preserving proprietary/patent 
positions, which also affords the private sector the benefits of voluntary 
registration . 
Also, the 10 liter volume restriction (Section I-D-6) would appear 
to apply to all categories of experiments (Section I-E), including those 
which have otherwise been exempted from the guidelines and NIH registration. 
This specific policy is unduly restrictive as written, though the implica- 
tion may not be the intended meaning. This section also indicates that 
"appropriate levels of physical and biological containment" will be assigned 
[A-360] 
Representing manufacturers of prescription pharmaceuticals, 
medical devices and diagnostic products 
