MINUTES OF MEETING - December 6-7 
25 
notice in some formal way that this was unacceptable behavior, 
perhaps in a letter from Dr. Fredrickson or the Secretary. It 
was noted that some drug companies have contracts with Genentech. 
It might be helpful, Mr. Libassi pointed out, if the companies 
insisted that all their contractees adhere to the NIH Guidelines. 
The PMA representatives agreed to work for industrial compliance." 
Mr. Thornton asked Dr. Gartland to comment. Dr. Gartland said 
that his statement yesterday concerning Genentech and their 
scale-up in October of 1978 under the 1976 Guidelines is accurate. 
He said the May 25, 1979, Minutes cited above are not precise. 
Dr. Ross said that Genentech did not have a representative at 
that meeting. Dr. Novick said he did not think the May 25, 1979, 
Minutes germane to the issue before the RAC. Mr. Thornton asked 
if Genentech had said they were in violation and would continue 
in violation. Dr. Gartland and Dr. Ross said that they had not. 
Dr. Goldstein said that the RAC had previously passed a motion 
recommending mandatory regulation. Dr. Walters pointed out that 
the vote on this recommendation was 9-6-6. He said that the 
interagency committee which Dr. Fredrickson had convened agreed 
with the voluntary compliance scheme. Dr. Ahmed said he favored 
uniform standards and uniform regulations. Dr. Adams of PMA 
said that industry has indicated its willingness to abide by the 
Guidelines. He pointed out that the RAC is proposing an action 
to consider the expiration of a section of the Guidelines that 
is still only preposed. Dr. Johnson of Eli Lilly stated that 
the term voluntary is a misconception, as industry is under 
constant monitoring by a large number of regulatory agencies. 
Dr. Adams said that PMA firms are subject to inspection by OSHA 
relative to biohazards. 
Mr. Thornton said that three procedural options are open to the 
RAC. (1) Dr. Krimsky's motion could be adopted. Presumably, the 
RAC would not review further large-scale proposals. (2) the RAC 
could accept voluntary compliance until such time as Congress 
adepts a law establishing mandatory compliance. Or (3) the RAC 
could propose a reevaluation of the its role after aquiring some 
experience in the application of voluntary compliance. 
Ms. King said that she is opposed to voluntary compliance as 
the mode of regulation applied to academia should be the same 
as applied to industry. She said she none the less supports 
Dr. Novick' s motion because it provides the opportunity to 
evaluate voluntary compliance after acquiring seme experience. 
Ms. King stated that tort sanctions work. Researchers are very 
concerned about their prestige and their status in the profession. 
[ 418 ] 
