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:

List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report