FDA Outlines 5 Years of Priorities – What to Expect for Your Business

By Mike Rozembajgier

The Food Safety Modernization Act (FSMA) is likely to bring enormous changes to the current regulatory landscape in the coming years. And now the Food and Drug Administration (FDA) is indicating just what some of those changes may be.

The FDA just released its “Strategic Priorities” for the next four years, and, while the full report is more than 50 pages long, it focuses on five basic goals:

• Draw upon “regulatory science” to help assess the safety of new and older medical devices;
• Focus on prevention and nutrition as central parts of a global food safety network;
• Expand efforts to meet the needs of “special populations” such as women, children and minorities;
• Set up emergency medical countermeasures; and
• Increase compliance and enforcement.

While all of the priorities are important, the one most pertinent to companies dealing with the FDA on a daily basis is the first, which addresses regulatory science. “Regulatory science,” for those unfamiliar with the term, refers to applying technological innovation to the process of ensuring the safety of food, consumer products, and medical devices. FDA Commissioner Margaret Hamburg, in her introductory letter to the report, writes that she plans to especially emphasize this priority.

The report goes on to explain that advances in technology “are enabling us to more efficiently identify microbial pathogens, track and trace food contamination outbreaks, develop new approaches to safety assessment …”

Trends over the past several years have been moving increasingly toward requiring companies to be more actively involved in communicating their internal compliance and quality procedures to the government. In fact, the FSMA does just this, and the latest strategic priorities once again emphasize the importance of effective compliance communication.

Just as the FSMA requires companies to share their food safety plans with regulators, it is hardly a stretch to predict that the agency will soon require companies to share their use of regulatory science. Although a large portion of regulatory science revolves around studies conducted by universities and other non-corporate entities, the report notes that “the strategic plan for advancing regulatory science will pave the way for a range of regulatory activities, including … protecting the food supply.”

Companies should expect soon to be required to devote more resources to applying regulatory science and sharing their efforts with the FDA, an additional consideration when planning regulatory and recall strategy.

As the FDA prepares to enter previously uncharted regulatory territory, companies need to be sure that they can anticipate what the agency might do next and what they will have to do in response. Recall partners do this best, and at Stericycle ExpertRECALL, our experts work every day to keep up with changing compliance requirements; recording and presenting compliance procedures; and anticipating future compliance issues.

The FDA has shown in recent years that it is ready to pressure companies to share more of their food safety compliance data and plans. The agency’s latest priorities report only reinforces that inclination.

Smart companies always stay a few steps ahead of the FDA. Act now to include a look at regulatory science in your own five-year plans, mirroring the FDA’s decision to emphasize this latest regulatory initiative.