i 
Biotechnology 
The Issue to be Addressed 
Recent advances in biotechnology, specifically in 
recombinant DNA (rDNA) technology, offer the pharmaceutical 
industry the capability and potential for: 
(1) improving production efficiencies for 
existing products; 
(2) creating therapeutic and diagnostic products 
which are found in nature but which otherwise 
could not be produced economically for 
commercial use; and, 
(3) creating therapeutic and diagnostic products 
which otherwise could not be synthesized or 
extracted . 
In addition, rDNA technology offers the medical 
capability and potential for: 
Cl) intervening genetically in humans to treat 
known genetic defects; and, 
(2) performing in humans other genetic 
investigations such as genetic engineering 
experiments . 
The first set of advances involve the application of 
rDNA technologies in microorganisms. The use of the technology 
in this manner is well under control and differs little from the 
production of drugs or chemicals by more conventional 
techniques. However, the second set of advances, biological 
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