Updating the FDA’s information systems is one of the agency’s top priorities, FDA Commissioner Andrew von Eschenbach, MD, reported April 22 to the House Energy and Commerce subcommittee on oversight and investigations.
The committee is investigating the FDA actions to improve the safety of medical devices and products made with foreign components.
The Commissioner said that the FDA needs to modernize its IT infrastructure to better use data it already has and to better coordinate various activities within the agency. Existing information systems, for instance, do not have the capability to automatically verify information submitted by foreign firms that ship components of regulated products into the United States, von Eschenbach said.
The FDA plans to enhance its IT systems in ways that will enable the agency to better utilize risk-based information from the entire life-cycle of imported products,” von Eschenbach testified. “Many of these improvements will be implemented in the next two years; implementation of a few will extend beyond 2010. These projects will improve databases, enhance interoperability of systems within the agency and among other regulatory agencies and provide better analytical function to assess and control risk.”
The FDA hopes the IT improvements will aid with certain initiatives, such as:
- Maximizing foreign prescription drug pre-approval inspections;
- The Beyond Our Borders Initiative, a systems-based approach to the systemic problem of the agency regulation of food, cosmetics, and medical products;
- Sharing foreign inspection reports;
- Increasing foreign presence;
- Providing for certification by third parties;
- Implementing foreign vendor registration verification; and
- Issuing good importer practices;
- Increasing surveillance inspections; and
- Holding U.S. manufacturers accountable.
von Eschenbach said the “agency will learn and adapt as we move forward as part of the larger, ongoing agency transformation into an FDA of the 21st century. We need the partnership of Congress to provide the resources and authorities needed for the agency to enhance our import safety system to handle the multiple and complex changes facing us today. Even with the challenges presented by globalization, the American product supply for drugs and devices continues to be among the safest in the world,” in a statement released on its website.