FDA Recall Process Not Enough for Congress

By Howard Aughinbaugh

This may go down in history as the year that Congress took a close look at the Food and Drug Administration (FDA)’s ability to keep consumers safe and then empowered the agency with tougher regulations and stricter enforcement authority. From food to pharmaceutical products to medical devices, recent Congressional inquiries into the FDA’s ability to protect consumers could lead to new regulations that affect how companies approach their recall management and navigate the complicated recall process.

Not only has the FDA been granted new powers under the Food Safety Modernization Act, but a recent Government Accountability Office (GAO) report and congressional hearing are looking into the agency’s medical device approval process. Congress is also now taking a look at agency’s “slower-than-expected” implementation of a newly launched import screening system.

Last week, FDA Commissioner Margaret Hamburg testified at a House Energy and Commerce Subcommittee on Oversight on the agency’s implementation of Predictive Risk-Based Evaluation for Dynamic Import Compliance Testing (PREDICT), a system that aims to monitor imported products and is designed, through a numerical score process, to strategically select which shipments and which goods to inspect.

The new system is critical because the FDA has oversight of products imported to the U.S. from more than 150 countries. There are currently more than 130,000 importers of record, with products arriving from more than 300,000 facilities around the world. The FDA is only able to inspect about two percent of all imported products.

But once implemented, PREDICT is expected to help the agency more effectively identify the shipments to target and hopefully increase the number of inspections the agency can conduct. While the PREDICT system was launched last year, it is currently only used in Los Angeles, New York, Seattle and San Francisco. Congress wants faster action, and in today’s regulatory environment, lawmakers are sending a clear message to watchdog agencies: we want change now.

As a manufacturer or importer, you are not only under scrutiny from regulatory agencies, but now also Congress. When Congress takes aim at the regulatory agencies, expect the agency that regulates your business to wield a heavier hand. With Congress actively looking into the FDA, your company should act now to review your internal procedures and double check to make sure your overseas partners are importing safe products and following appropriate manufacturing procedures at their facilities.

In this era of increased accountability, supply chain management is critical, particularly when imported goods are a primary target for the FDA. Now is the time to review import criteria, logistics and manufacturing policies. Otherwise you face the risk that the FDA will block your products from entering the U.S. market and put your company on the agency’s watch list.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.