SOURCE: Stericycle ExpertSOLUTIONS

Stericycle ExpertSOLUTIONS

February 17, 2016 09:30 ET

A Puzzling Prescription: Pharmaceutical Industry Trends Pose New Regulatory and Recall Challenges

Q4 2015 Stericycle Recall Index Cites Influx of Drugs Entering Market and Mergers and Acquisitions as Factors

INDIANAPOLIS, IN--(Marketwired - Feb 17, 2016) - Stericycle ExpertSOLUTIONS™ (NASDAQ: SRCL) today released the findings of its Q4 2015 Stericycle Recall Index. The report highlighted the complexities surrounding the pharmaceutical industry, especially as it pertains to counterfeit drugs, mergers and acquisitions (M&A), and regulatory shifts.

The Q4 Index noted that 2015 saw significant change in the industry, with a huge influx of legitimate and counterfeit drugs introduced to the market. The Food and Drug Administration (FDA) approved 45 new medications in 2015 -- more than double the number approved just ten years ago. The counterfeit drug industry, worth roughly $200 billion annually, also continues to grow. According to the FDA, this trend is due to the large quantity of high-cost drugs, advancements in manufacturing technologies that make it easier to create counterfeits, and the proliferation of Internet drug purchases. These trends make it challenging from a recall perspective, as companies facing a recall need to first determine if it's actually their drug that needs to be removed from the market.

"In 2015, the pharmaceutical industry faced challenges on several new fronts," said Kevin Pollack, Vice President, Stericycle ExpertSOLUTIONS. "The regulatory burden continued to evolve and the explosion of counterfeit drugs presented manufacturers with many new issues. The full measure of this remains to be seen, but these trends will likely impact recalls in 2016 and beyond. Those brands that are prepared and proactive will have the advantage."

Consolidation was another major theme identified in the Q4 Index, with a record number of M&A deals in 2015, totaling $687 billion in the U.S. alone. According to the data, there were 50 FDA pharmaceutical recalls in Q4, down 25 percent from Q3, and fewer companies experienced a recall in 2015. While the number of companies has decreased, the consolidation brings a new set of problems. M&A activity puts pressure on businesses to combine resources, such as merging disparate tracking systems and quality control mechanisms. This adds heightened sensitivities and changes to the pharmaceutical supply chain, and ultimately to recall plans.

With continuing global supply chain complexities and increasing drug development, the pharmaceutical industry will be watching new legislation closely. The pending 21st Century Cures Act would accelerate the approval process for certain drugs, which could make the increase in FDA approvals the start of a major trend. As a result, the potential for a recall has never been higher.

"As complexities increase, navigating the global pharmaceutical environment has never been more difficult -- and this is a trend we expect to continue," said Pollack. "Recall preparedness is more important than ever. Companies must have a method for tracking and consolidating critical data to ensure compliant regulatory reporting. As we've seen in recent years, it's not a matter of if a recall hits, it's a matter of when."

To learn more about the changes to the pharmaceutical marketplace and review additional findings from the Q4 2015 Stericycle Recall Index, please access the report in its entirety here.

About the Stericycle Recall Index
The Stericycle Recall Index is the only report that aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA and the USDA. For more information, please visit www.stericycleexpertsolutions.com/thought-leadership.

About Stericycle ExpertSOLUTIONS™
Stericycle Inc. is a NASDAQ-listed global business-to-business services company which provides highly specialized solutions to healthcare and commercial businesses of all sizes. Founded in 1989, Stericycle Inc. has grown to become a leader across a range of complex and highly regulated market sectors and operates in 550 locations. Stericycle ExpertSOLUTIONS™ is the industry leader in managing automotive, consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertSOLUTIONS streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for leading global companies. For more information, visit www.stericycleexpertsolutions.com.

Contact Information