To

FROM

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fob. POA

Date: March 8, 1977

Don Kenned
Human Biology Program

Joshua Lederberg
Department of Genetics

Safety regulations with regard to recombinant DNA.

Dear Don,

I do not know if events will overtake this message before you are in
a position to even think about it. But I think there is a great contribution
that you could make about settling unnecessary anxieties with respect to
“commercial transgressions’ of the NIH guidelines. Apart from the question
whether research on recombinant DNA should be conducted at all, the main
sore point in this issue may well be the perception that although
government funded activity is properly regulated, industrial-commercial
interests may be able to "get away with murder".

My suggestion is that in your new role you issue an “advisory
bulletin" that pharmaceutical dvelopers and manufacturers who intend to
explore the use of DNA recombinant technology should take pains to be sure
that they can document that they are and will have been adhering to relevant

NIH guidelines throughout the entire process. Whatever may be the appropriate

mechanism of ongoing inspection, this documentation can certainly be called

for at the time that a prospective new product is presented to the FDA for
IND or NDA review.

If you were to make this statement as an interim measure, pending what
ever other steps may be undertaken either by regulation or other legislation,
I think it would go a long way to assuring the public that there is not
likely to be an instant emergency that requires what may be an erence
impossible or excessive reaction.

Of course, I would urge nothing on you in this direction without your
having taken great pains to consult others about its possible side-effects.
At the moment it would seem to me to offer a great deal to gain and
absolutely nothing to lose. I am sure that the industry would be more

than eager to comply, indeed would be grateful to have some definable frame-
work in which compliance will be possible.

I am not suggesting that this approach will satisfy every critic nor
would I want you to put yourself on the spot as implying that it is a
sufficient permanent response to the controversy. But I do think that as an
interim measure it would have an effect that could only be positive.

Sincerely yours,

sp

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