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Free James Kimball


Mr. Daniel L. Michels, Director
Office of Compliance
Center for Drug Evaluarion and Research
HFD-300
5600 Fishers Lane
Rockville, Maryland 20857

Dear Mr Michels:

On 12/20/90, we wrote you about the illegal marketing of a product called Kimbellac by Discovery Experimental and Development Co., Wesley Chapel, Florida 33543      Subsequently, writer talked to Mr. R. J Chastoney amd his associate, Ms. M. Richardson, requesting an immediate investigation of this company.  We have also talked with a Mr M Katz, Compliance officer at the FDA Orlando District Director's office request an immediate investigation of this company    Hopefuly an investigation will begin on 1/2/91

A representitive of Somerset Pharmaceuticals, Inc. has recently ordered a bottle od Kimbellac from Discovery Experimental and Development Co. and recieved the enclosed literature from the company.  We are appalled by the company's disreguard for FDA regulations and surprised by their philosophy   it is quite apparent they are rationalizing their decision to market a new drug without new drug approval

We urgently request your immediate investigation of this company and the immediate cessation of their marketing and sales of the product

Thank you for your prompt attention to this matter.  Somerset wil continue to contact the FDA and request a status of their investigation and the issuance of a ceaseand desist order

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Sincerely,

John V. Saenger
Vice President

CC:
Ronald C. Chesemore (HFC-1)
Richard J  Chastoney (HFD-310)
Edward Fry  (HFD-300)
Davis A. Kessler, M.D. (HF-1)
Carl Peck, M.D.  (HFD-1)
Douglas Tolen  (Orlando Districr Office)