ML20028C567

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Responds to 820717 Request for Info Re Use of Potassium Iodate for Thyroid Blocking Agent.Fda Approval of Potassium Iodate Too Costly & Time Consuming.W/O Stated Encl
ML20028C567
Person / Time
Issue date: 07/30/1982
From: Tang R
Advisory Committee on Reactor Safeguards
To: Murri E
NUS CORP.
Shared Package
ML20027A756 List:
References
FOIA-82-557 NUDOCS 8301100432
Download: ML20028C567 (2)


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NUCLEAR REGULATORY COMMISSION 3-

-c ADVISORY COr.wiTTEE ON REACTOR SAFEGUARDS I

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WASWNGTON, D. C. 70555 July 30,1982 Mr. Ernie L. Murri Executive Consultant Health Physics Department NUS Corporation N

910 Clopper Road Gaithersburg, Maryland 20878

Dear Mr. Murri:

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Thank you very much for your letter to Dr. Dade Moeller, dated July 17,1982, in which you asked why potassium iodide appeared to be the only thyroid blocking agent under consideration in the U.S.,

while the responsible authorities in Canada, South Africa, and several European countries had opted for potassium iodate.

During the ACRS Subcommittee Meeting on Reactor Radiological Effects and Site Evaluation on June 23, 1982, the issue of iodide vs iodate was discussed extensively.

As you will find in the enclosed meeting transcript (e.g., Dr. Saenger, P.149, P.152; Dr. Shleien, FDA, P.172; Dr. Becker, American Thyroid Association, P. 715-216),

we do not have much experience with todate in the U.

S., and the approval of an Investigation of New Drug (IND) and a New Drug Application (NDA) would be required from the FDA for testing the safety and efficscy of todate, which is very costly and time con-suming.

On the other hand, iodide (KI) has been used in the U.S.

.for clinical purposes for many years.

It is now recommended for use as a thyroid blocking agent by various authorities in the U.S.

(including FDA) because of its degree of blocking achieved, its availability under present FDA regulations (approved NDA for KI in both tablet and solution form), and its relatively fewer side e ffects, etc.

I hope that this has answered your question.

Please j

do not hesitate to contact us should you have further comments re-garding this issue.

I can be reached at (202) 634-1413.

Sincerely,

/

N D

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R. C. Tang Staff Engineer Enclosure :

PP.123 293 e

6/23/82 Meeting Transcript 2 !: - 7 a

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See next page 8301100432 821210

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