Judith Robinson MAY 26 197:
Professional Staff Member fe
Subcommittee on Employment, Poverty 2,

Nh»
and Migratory Labor ‘ blo,

May 22, 1978

Professor Joshua Lederberg

Department of Genetics

Stanford University School of Medicine
300 Pasteur Drive

Palo Alto, California 930)

Dear Dr. Lederberg,

Thank you very much for taking the time
to meet with me and to have lunch with us
while Iwas at Stanford May 10. I aprreci-
ate your sending the article on laboratory
practices and your statement on DNA
research, which I shared with Senator
Stevenson's staff and cther Senate staff.

It is anticipated that a letter signed
by several Senators will be sent to HEW
shortly, inquiring about existing statutory
authority as a mechanism for monitoring
DNA research, I specifically have included
reference, per your suggestion, to the
FDA's authority to require compliance with
NIH guidelines by private industry. En-
closed is a page from a letter to Sen.
Stevenson from Secy. Califano following
the Senate Commerce Science Subc. hearings
last Nov. on DNA, in which this matter is
addressed,

I also appreciate receiving' your draft
language and thoughts on Delaney.

We'll be in further touch, and let us
know if we can assist you in any way,

221 Russell Senate Offi i J .
(202) 224-4538 or 224-5323 .

   
Boek le heLinr. 2D re fle,

et

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nS Pa) go regulate a number of products
tte" Jang shellfish, pet turtles, primates,
Braden blood. Our Office of the General

as of Siaves it is preferable for a regulatory effort
Foe ofe-

Pan" versee all recombinant DNA activities
Beater yeose required to © ?
ae oe

   

se sot known to affect human health, to be based on the
2, OF

Sees support of the Congress as well as that of the Administration,
sonnet acularly in light of the active interest the Congress has shown

in this area. The consensus needed for this type of program is not

best established by applying a general provision of law to this -
specific situation.

2. Other HEW Authorities

The Food and Drug Administration: (FDA) is .responsible for assuring
that human drugs, biologics, medical devices, foods, cosmetics, and
animal drugs, are safe, effective, and are produced. in’ conformity
with good manufacturing practices.. For all new drugs, new animal :
drugs, biologics, food additives and color additives, and medical
devices, the sponsor or manufacturer has the burde
the safety and efficacy of products proposed for marketing. The
Federal Food, Drug, and Cosmetic Act requires manufacturers of such .
products to submit safety and efficacy data supporting their petitions

to FDA for review and approval before the product is introduced
4 into interstate commerce.

n of demonstrating

The FDA has responsibility to safeguard the public from all potential

hazards that may result from the development of products that are

subject to the Agency's jurisdiction. This authority would extend

to research on regulated products where recombinant DNA is involved.

The Agency could, under existing authority, require any firm seeking ,
approval of a product which may be the end product of recombinant

DNA research to certify to the Agency that it has complied with the ’
National Institutes of Health (NIH) Guidelines on recombinant DNAS © :
For example, certification could be required for biologics, requests:

for certification could be required in petitions, such as new drug
applications, license applications for biologics, requests for

certification of antibiotics, and notices of claimed investigational

exemption of a new drug. In addition, FDA under its investigational
authorities may inspect firms making such certification to assure

that they do, in fact, comply with the NIA guidelines. The Agency

does have a number of regulatory sanctions it qould bring to bear
n any firm not in compliance with the Guidelines

from a denial of the petition to court actions.

M) .
to KES
enw FRhaw : tere er fav,

    
 
 
  
 
    
 
  
  

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