- 7 - 
There is little doubt then that the drug industry will be able 
TO MEET APPROPRIATE STANDARDS FOR PHYSICAL AND BIOLOGICAL 
CONTAINMENT LEVELS OF RECOMBINANT DNA RESEARCH AND DEVELOPMENT. 
In FACT, A FAIL-SAFE SYSTEM AND A FAVORABLE 3ENEFIT-RISK RATIO HAVE 
ALREADY BEEN ESTABLISHED. 
The PMA Expert Advisory Committee, which was convened tn July 
AGREES THAT THE SPIRIT AND INTENT OF THE NIH GUIDELINES ARE QUITE 
ACCEPTABLE. THE PANEL FURTHER AGREES THAT WITH SOME MINOR MODIFICATIONS, 
PHARMACEUTICAL FIRMS WOULD HAVE FEW PROBLEMS IN APPLYING THE GUIDELINES 
TO THEIR OWN RESEARCH PROGRAMS. BASED ON RESPONSES TO DATE TO OUR 
REQUEST FOR COMMENTS AND SUBJECT TO THESE MINOR MODIFICATIONS 
WHICH DO NOT INVOLVE ELEMENTS OF RISK OR SAFETY, IT IS FAIR TO ASSUME 
THAT PMA MEMBER FIRMS WILL VOLUNTARILY COMPLY WITH THE GUIDELINES. 
IN NO INSTANCE WAS THERE ANY INDICATION BY OUR PANEL THAT THE 
Guidelines were inadequate to provide the necessary and desirable 
SAFEGUARDS. NOR WERE THERE ANY RESERVATIONS ABOUT INDUSTRY'S ABILITY 
TO COMPLY WITH THE PROPOSED CONTAINMENT LEVELS. It WAS ALSO THE 
CONSENSUS OF THE PANEL THAT THE CREATION OF RECOMBINANT DNA BlOHAZARD 
and/or Research Committees to review and approve research projects 
WOULD POSE NO SERIOUS PROBLEM TO INDUSTRY AND COULD EE QUICKLY IMPLEMENTED, 
Review of the records of the meetings of such Committees present no 
SERIOUS DIFFICULTY, EXCEPT INSOFAR AS SUCH MINUTES MIGHT INVOLVE 
PROPRIETARY OR TRADE SECRET INFORMATION. SUCH RECORDS SHOULD NOT 
NECESSARILY BE MADE PUBLIC, BUT THEY COULD BE MADE AVAILABLE TO 
APPROPRIATE AUTHORITIES WHERE CONFIDENTIALITY COULD BE GUARANTEED. We 
DO NOT VIEW THOSE FEATURES OF THE GUIDELINES WHICH MIGHT IMPINGE ON SUCH 
INTELLECTUAL PROPERTY RIGHTS AS INSURMOUNTABLE AND TRUST THAT SATISFACTORY 
MODI F I CT IONS TO THE GUIDELINES COULD BE ACHIEVED. 
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