SEPTEMBER 6-7 - MINUTES OF MEETING 
19 
drug sales, and better than 95% of the drug research dollars invested by 
private firms. Dr. Brill asked what actions would be taken against a firm 
which did not comply. Dr. Adams responded that as a trade association the 
PMA has no authority to impose any kind of penalty on a member. However, 
there may be other types of action which could be taken, such as a reprimand. 
Dr. Ahmed said that there is a limit to how well voluntary compliance 
will work. He stated that the supplement is not a long term solution. 
Mr. Thornton noted that at the moment no statute exists. Dr. Ahmed 
emphasized the point that the RAC at its May meeting went on record as 
supporting mandatory compliance. Mr. Thornton noted that the Federal 
Interagency Committee unanimously approved going forward with the volun- 
tary supplement. He felt, therefore, that the NIH should proceed with 
the proposed action and have a test period for voluntary compliance by 
the private sector. Dr. Ahmed raised the question of procedures dealing 
with disclosure of confidential information. He felt that NIH has no 
criteria on which an FOI officer may proceed on the issue of confidentiality. 
Dr. Johnson observed that many regulatory agencies inspect the PMA member 
companies in one way or another. Dr. Walters agreed with Mr. Thornton; 
he felt that NIH should offer a program of voluntary compliance to the 
private sector. Dr. Walters then asked whether this pledge of the PMA 
applies to research conducted overseas as well as to domestic research. 
Dr. Johnson noted that any research done overseas would have to be 
done according to the host country's laws and regulations. Dr. Novick 
emphasized that the RAC cannot really discuss foreign statutes as the 
RAC has no say in the laws and procedures of other countries. 
Dr. Gottesman questioned whether some other procedure could be substituted 
for the public comment procedure when dealing with proprietary information. 
For example, should a RAC vote greater than majority be required, or should 
more outside experts be consulted? Dr. Johnson noted that FDA uses public 
advisory committees in closed session. Dr. Baltimore moved to approve the 
supplement. He noted that industry is open to public pressures. A public 
participant then asked whether a lay member of an industrial IBC would be 
able to consult with outside experts. Dr. Johnson added that Eli Lilly 
has no legal agreement considering confidentiality with its outside IBC 
members. Dr. Williams at this point seconded Dr. Baltimore's motion. 
Dr. Krimsky stated that he is still concerned with the problem of non- 
compliance. He questioned whether any precedents for voluntary compliance 
exist, and wondered if representatives from OSHA or NIOSH were present 
who might comment. Representatives of NIOSH and NSF noted that the Inter- 
agency Committee had unanimously recommended proceeding with the supplement 
for voluntary compliance. Dr. Gottesman noted that at the moment there is 
either a voluntary compliance scheme or nothing to vote on. Dr. Adamson 
representing the Office of Science and Technology Policy stated that the 
OSTP views voluntary compliance as a step forward, and it is doubtful that 
any legislation would pass in this session of Gongress. Dr. Simon of 
Genex Corporation stated that Genex agrees to comply with the Guidelines. 
Dr. Ahmed questioned whether this voluntary compliance by industry would 
become permanent. He felt that it should be purely temporary. 
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