Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this month.

Life in FDA's fast lane

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

iStock_med_bottle_wash
iStock_med_bottle_wash

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:

Break out of the ordinary: see what’s new in life sciences packaging
At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us this month to experience a breakthrough for life sciences products.
REGISTER NOW!
Break out of the ordinary: see what’s new in life sciences packaging
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report