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Life in FDA's fast lane

A proactive approach to increased FDA enforcement serves as a good guide for Philips Healthcare.

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Griping about increased enforcement, aggressive inspections, and more frequent Warning Letters from the U.S. Food and Drug Administration is easy, but taking a proactive approach to the present regulatory environment is a much sounder tack for Philips Healthcare.

The Andover, MA, company’s Web site says that Philips’ “focus [is]on the fundamental health problems with which people are confronted, such as congestive heart failure, lung and breast cancers and coronary artery disease.”

“The FDA is in a difficult position,” says LeeAnn Rogus, vice president, quality and regulatory compliance, Philips Healthcare. “The general public and the House and Senate want tougher rules, while the industry doesn’t want its hands tied down by regulation.”

Rogus presented “Lessons Learned: How Product Failures, Recalls and GMP/QSR Problems Trigger FDA Enforcement Actions,” during a Sept. 22 conference session entitled, “Surviving a New Era of FDA Enforcement,” at Medical Design & Manufacturing Chicago.

Rogus made it clear that the more muscular FDA is striving for speed as part of an effort to safeguard the public from potential harm. “Facilities have been hit with very aggressive FDA inspections in the U.S., Europe, and China. They expect more corrections and removals, more recalls, and are making the process much more visible. If the agency finds a problem, they want you to issue press releases in a day.”

She believes the FDA is initially focusing its regulatory aim at larger companies where the agency can “get its biggest bang for the buck with so much exposure related to public health.”

During a candid, informative presentation, Rogus provided the following insights:

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