11 
The working group agreed transgenic germ line modifying procedures are not 
feasible or acceptable for humans at this time. 
The FDA IND Process 
Dr. Walters asked D:. Samuel Ackerman of the Bureau of Drugs and Biologies 
of the FDA to describe to the working group the process of filing a "Notice 
of Claimed Investigational Exemption for a New Drug (IND)." 
Dr. Ackerman said biologies are defined as materials that come from the blood, 
except for hormones, and materials that ccme from microorganisms. The Bureau 
of Biologies is responsible for products such as albumin, viral vaccines, and 
bacterial vaccines. The Bureau also has jurisdiction over a number of products 
produced by biotechnology such as monoclonal antibodies, cytokines, and anti-HTLV 
III test kits. 
Dr. Ackerman said the Bureau of Drugs and Biologies is responsible for regulating 
investigational stages in drug testing, commercial approval of drugs, and 
periodic examination of products. An IND (Attachment III) must be filed if any 
of the products used in a procedure are transported across state lines. 
Dr. Ackerman said the IND mechanism primarily monitors clinical trials where 
the major goal is to demonstrate product safety and efficacy. Wien clinical 
trials demonstrate safety and efficacy, the product can be licensed, and the 
commercial production phase begun. The FDA is then responsible for reviewing 
the integrity of the production process, the facility, and any changes in the 
manufactured product. 
Dr. Ackerman said the IND is keyed to the product and not to the process or 
the investigator. Indeed, several different investigational groups can file a 
single IND. The IND is confidential; its existence cannot be divulged, although 
a Freedom of Information request can be filed to obtain certain information. 
Dr . Ackerman then described the information requested by the IND form. Items one 
through five deal with the preparation and manufacture of the product, and address 
issues such as identity, components, source, preparation, purity, strength, 
reproducibility, stability of material , etc. The sixth item requests all 
available information derived from preclinical investigations, clinical studies, 
and experience with the drug. Items seven through ten deal with the proposed 
clinical investigation. Item seven requests an accurate description of prior 
investigations and experiences and results pertinent to the safety and efficacy 
of the drug under the conditions of the investigation; it also requests a descrip- 
tion of all relevant hazards, contraindications, side-effects, and precautions 
suggested by prior investigations and experience with the drug or related drugs. 
The eighth item requests a description of the scientific training and experience 
considered appropriate to qualify the investigators or suitable experts to 
investigate the drug or biologic. The ninth item requests the names, training. 
( 577 ] 
