FDA Stresses Science-Based Compliance and Open Communication

(FDA: Salt Lake City)—Utah-based life science companies are being implored to utilize a scientific approach to regulatory compliance, and to keep the lines of communication open with the Food and Drug Administration. FDA district director Tom Warwick recently spoke with hundreds of life-science professionals during a special lunch meeting hosted by the Utah Technology Council (UTC) and Intermountain Biomedical Association (IBA). Warwick heads the Denver office of the FDA, which covers Utah and other surrounding states.

Warwick answered questions and concerns from the more than 300 life-science professionals in attendance. The majority of the questions were directed at FDA inspections and the FDA’s plan for 2009. “Our inspectors are taught to be professional, open, and transparent,” said Warwick. “Our goal is to develop respectful relationships with the companies we inspect.”

Warwick also spoke about the work plan for FDA in coming years, and the significant increase in staffing over the past two years because of new legislation and Congressional mandates. With increased staffing, food safety will be a major focus both domestically and internationally.

"Communication between our inspectors and business owners is the breakfast of champions,” said Warwick. He also spoke to the crowd regarding sensitive information and what FDA can and cannot disclose to the public. “Records collected during inspections are very rarely shared because they often contain nondisclosable information,” Warwick continued. “Any trade secrets, commercial confidential information, or personal information is always taken out of our reports.”

Utah’s growth in the life science fields is a hot-button issue. "Life-science companies in Utah continue to prosper,” says Richard Nelson, UTC's CEO and president. “We have more than 1,000 of these companies and we are enthused to have an industry partnership with the FDA.”

Warwick echoed this sentiment, “I would like to see Utah and this district pursue open dialog and interaction with the industry as it is a mutually-beneficial relationship.”

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