4 
as "new drugs." Dr. Miller said that industry agrees, at least for the first 
drugs made by recombinant DNA techniques, that the intense scrutiny provided by 
the IND process is in everyone's best interest. Some subcommittee members 
expressed concern that this FDA tentative decision could tend to discourage small 
companies with little IND experience, and could lead to unnecessary delays in 
getting these drugs to the public. Dr. Miller pointed out that, in fact, some 
companies are entering the IND process for the first time, and that evaluation by 
FDA of these submissions is on the "fast track." 
Dr. Miller reported that FDA has issued a proposed rule ( Federal Register , 
December 11, 1979, pages 71742-71749), but not as yet a final rule, concerning 
agency policies and procedures for complying with the National Environmental Policy 
Act (NEPA), including the preparation of environmental assessments and environ- 
mental impact statements. One approach being considered is to make it known to 
industry that FDA will view a manufacturer's compliance with the NIH Guidelines 
as mitigation of any potential adverse effects to the environment from this 
technology. Consequently, in most instances, when such assurances were made, 
FDA would not seek further environmental review in the form of an Environmental 
Impact Statement. Some subcommittee members said this was a desirable way to 
encourage compliance with the Guidelines; others, however, believed it might be 
interpreted as an inappropriate change in the current voluntary, good-faith 
compliance by industry. 
>|a 
■ 
se: 
Dr. Miller reported that the FDA conducts premarket inspections of manufac- 
1 s ei 
turing plants. On those inspections, if FDA recognizes a potential problem relating 
I' 
to the jurisdiction of another agency belonging to the Interagency Regulatory 
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