2 
Dr. Walters called the meeting of a Suhworkinq Group on Human Gene Therapy to 
order at 9:10 a.m. on September 20, 1985. Dr. Walters said the siioworking 
qroup would be dealing with three agenda items: (1) a review of the comments 
received on the August 19, 1985, Federal Register version of the "Points to 
Consider in the Design and Submission of Hunan Somatic-Cell Gene Therapy 
(Attachment II);" (2) a discussion of the optimal presentation of the "Points 
to Consider" to the Recombinant DNA Advisory Committee (RAC) at the September 
23, 1985, meeting; and (3) a discussion of date(s) and agenda(s) for future 
meetings of the Working Group on Human Gene Therapy. 
Dr. Walters called the attention of the subworking group to a letter (Attachment 
III) from Senator Albert Gore to the Secretary of Health and Human Services 
(HHS) Margaret Heckler. Senator Gore said he was "writing to express his 
concern over the current effort of the Food and Drug Administration and the 
proposed Biotechnology Science Board to usurp the role of the National Institutes 
of Health Recombinant DNA Advisory Committee in overseeing human gene therapy 
experiments." He wrote he was opposed to this effort: and called upon Secretary 
Heckler to end it immediately. Senator Gore wrote that the Recombinant DNA 
Advisory Committee (RAC) has adequately addressed the scientific issues to 
date, and it appears capable of continuing to do so for the iirmediate future. 
Review of Cements on August 1985 Version of Points to Consider 
Dr. Walters pointed out to the subworking group the differences between the 
August 19, 1985, version of the points to consider document (Attachment II) 
and the May 3, 1985, version: (1) Language indicating the applicability 
of the points to consider has been added to the document. (2) The first 
footnote has been amended to indicate the document refers to recombinant 
DMA and DNA derived from recombinant DNA. (3) A paragraph was deleted from 
the Introduction ; that paragraph indicated the document is designed to cover 
the initial human somatic cell gene therapy protocols and that initial protocols 
are expected to involve only one or a few patients at a time. (4) A footnote 
describing the role of the Food and Drug Administration (FDA) was added to the 
document. (5) In the tenth paragraph of the Introduction the word "possible" 
had been substituted for the word "primary" in referring to consequences of 
scmatic cell therapy. (6) A sentence indicating it is likely that possible 
undesirable side effects can be prevented was deleted frem the document. 
(7) A sentence requesting that the consent form routinely be included as part 
of the submission has been deleted fran this version of the points to consider 
document at the request of the National Institutes of Health (NIH) legal counsel 
since NIH does not routinely request consent forms. A sentence indicating the 
working group may request submission of the consent form in certain cases has 
been added to Section III-A. 
Mr. Mitchell asked hew the language describing FDA's role had been developed. 
Dr. Gartland replied that FDA legal counsel had developed that language. 
Mr. Mitchell said questions had been raised at the May 3, 1985, RAC meeting 
concerning adequately distinguishing between the consent form and the consent 
[ 331 ] 
