11 
by recombinant DNA techniques has an extra methionine residue compared to the 
native human hormone, and even though the interferon made by recombinant DNA 
techniques is not glycosylated. No toxicity of the recombinant DNA-made 
products was demonstrated in animal tests including those in primates. 
Recombinant DMA-derived interferon was extremely bioactive in protecting 
against a lethal dose of virus in squirrel monkeys. FDA will soon be 
receiving applications to test recombinant DNA-made pharmaceuticals in man. 
Such products will require batch- to-batch analysis for identity by 
"fingerprinting" techniques since there is the possibility of coding sequence 
mutationsin a cloned gene. Possible toxicity, for example from unusual 
immunogenici ty , will be looked for closely in preclinical and clinical studies. 
Recombinant DNA-made pharmaceuticals will require all the usual FDA checks of 
safety and efficacy. The only difference from conventionally derived drugs 
will be that a company with an already existing IND or NDA for a drug prepared 
by conventional means will not be allowed to substitute a recombinant DNA-derived 
product under an existing application, but rather will be required to file a new 
IND and NDA. 
Plans For The Next Meeting 
Dr. Omenn announced that the next Subcommittee meeting would be on Thursday, 
September 4 } from 1:00 to 3:00 p.m. in Room 3104, New Executive Office Building. 
Dr, Harmison said there is more to consider about potential hazards 
than worker safety, and he hoped EPA could report from their point of view 
considering potential hazards to the general population. Dr. Levin agreed 
to make a presentation at the next Subcommittee meeting concerning EPA's 
activities, including their solicitation of grant proposals in the area of 
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