Inspections, Compliance, Enforcement, and Criminal Investigations
Cayman Chemical Company, Response Letter 1/29/10
January 29, 2010
Constance Lewin, M.D., M.P.H.
Branch Chief, Good Clinical Practice Branch I
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Bldg. 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993
FAXED TO: 301-847-8748
ORIGINAL SENT VIA FEDERAL EXPRESS
Dear Dr. Lewin,
This is to acknowledge receipt on January 20, 2010 of the above referenced letter. This letter is in follow up to inspections conducted by FDA in December 2007 and again in May 2009. The inspections related to studies conducted with three different compounds to determine the cosmetic effect of specific prostaglandins in a formulation for use as an eyeliner. Responses were provided to the agency in response to each inspection.
The above referenced letter states that the studies were not done in compliance with FDA’s regulations for conducting clinical studies for investigational new drugs. As previously explained, it was not our intent to conduct clinical studies for an investigational new drug. In the letter from Dr. Ball, she requests that the company specify how it will ensure adherence to the regulations in the future.
Two of the studies identified in the letter were completed in late 2007. The third was completed in January 2008. Since that time the company has not sponsored or conducted any clinical study that could be construed as a cosmetic or investigational new drug study. There are no ongoing studies of any kind. There are no future studies planned, budgeted or anticipated.
Cayman Chemical Company is a manufacturer of over 4000 products, including only one prostaglandin Active Pharmaceutical Ingredient. Our Quality Assurance and Regulatory Compliance approach focuses on this activity. If in the future, the company decides to consider activities beyond its core business, we will retain regulatory experts to assist us and to ensure that those activities are done in compliance with applicable FDA requirements.
Kirk M. Maxey, MD
President & CEO
Shannon M. Stacey
VP Quality & Regulatory Affairs
CC: Leslie K. Ball, M.D., Director, Division of Scientific Investigations