-4- 
As YOU MAY BE AWARE,, REPRESENTATIVES OF THE DRUG INDUSTRY TOOK 
PART IN A MEETING CALLED BY THE DIRECTOR OF NIH ON JUNE 2 OF THIS 
YEAR. ON THAT OCCASION/ AS THE PPiA SPOKESMAN/ I SAID THAT OUR MEMBER 
FIRMS WOULD RESPOND TO THE REQUEST FOR CRITICAL REVIEW OF THE GUIDELINES 
AND THAT IMMEDIATE STEPPS WOULD EE TA’KEN TO CONVENE A PANEL OF EXPERTS 
FOR THAT PURPOSE. THAT PANEL HAS SINCE STUDIED THE QUESTION/ AND / 
IN ADDITION/ WE HAVE REQUESTED COMMENTS FROM ALL OF OUR MEMBER FIRMS 
FOR SUBMISSION TO THE DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH 
BY THE DUE DATE OF NOVEMBER 1, 
We commend the NIH for establishing Guidelines and / particularly/ 
FOR ITS EFFORTS IN SEEKING A CONSENSUS WITHIN THE SCIENTIFIC COMMUNITY 
AND FROM THE PUBLIC AND PRIVATE SECTORS, RESEARCH IN THIS FIELD 
HOLDS GREAT PROMISE/ AND IT IS FAIR TO EXPECT THAT THE SAME INNOVATIVE 
GENIUS WHICH LED TO ITS DISCOVERY CAN ALSO DESIGN SYSTEMS TO CONTROL 
IT THROUGH PEER REVIEW AND PHYSICAL AND BIOLOGICAL CONTAINMENT. 
It is important to NOTE THAT the DRUG industry is one of THE MOST 
SOPHISTICATED SCIENTIFIC INSTITUTIONS ENGAGED IN THE HANDLING OF 
BIOHAZARDOUS MATERIALS. SOME PMA MEMBER FIRMS HAVE LONG EXPERIENCE IN 
WORKING WITH PATHOGENIC BACTERIA/ VIRUSES/ RICKETTSIAL AND OTHER 
PATHOGENIC MICROBIOLOGICAL ORGANISMS. FOR EXAMPLE/ THE ENTIRE TECHNOLOGY 
OF VACCINE RESEARCH AND PRODUCTION REQUIRES INTIMATE KNOWLEDGE OF 
BACTERIAL AND VIRAL GENETICS AND IS BASED ON RIGID ADHERENCE TO APPROPRIATE 
LEVELS OF PHYSICAL AND BIOLOGICAL CONTAINMENT. 
Another example ~ the use of drug-resistant organisms to 
TEST NEW ANTIBIOTICS AND OTHER CHEMOTHERAPEUTIC AGENTS AGAINST THESE 
STRAINS OF PATHOGENIC MICROORGANISMS. SUCH RESEARCH HAS LED TO THE 
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