3 
been successfully cloned. Plant costs exceeded $70 million and 
other expenses were well into the tens of millions of dollars. 
It took over 1,000 man years to bring the product through the 
various stages of development, starting with fermentation scale- 
up and purification, through animal testing and human testing, 
and, finally reaching FDA marketing approval. Over 5% of 
Genentech's employees are working full time to make sure that 
the company satisfies all the relevant requirements of the 
product approval process. 
Another threat to the small firms — a threat common to the 
entire genetic engineering industry --is the keen international 
competition. The United States is currently the world leader, 
but our competitive advantage is fragile and diminishing. Japan 
is closing the gap at an alarming rate and is expected to catch 
us within two years. The Japanese government, as well as those 
of other major competitors like Britain and West Germany, have 
targeted biotechnology as a key technology of the future and 
have made serious commitments to furthering its development. 
The European countries have a distinct advantage over companies 
in the United States because they are not subject to product 
approval regulation which is as strict as that in this country. 
Any delays to market entry in the United States will have 
direct repercussions on international competition. Furthermore, 
if the regulatory costs and delays associated with marketing 
products in the United States become prohibitive, domestic firms 
may be forced to export technology in order to survive. 
[ 703 ] 
