Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Regulation, has reported to a Senate panel that while the agency plans to update its information systems to combat some of the recent regulatory mishaps involving imported products, pharma companies also need to be held accountable for the quality of their drugs and active pharmaceutical ingredients.
Recent adverse events and deaths linked to contaminated heparin have brought the drug’s supply chain under tremendous scrutiny as global regulators have instituted testing programs to ensure the quality of the drug supply.
The Government Accountability Office (GAO) estimated a significant gap in funding for overseas inspections. The GAO said it would take roughly $70 million annually for the FDA to inspect all overseas facilities every two years, $16 million to $17 million of which would be required for sites based in China. For fiscal 2008, the FDA estimated that it would spend $11 million for all foreign inspections.
Woodcock told the Senate panel that the FDA’s top priority was to institute an IT system that includes an inventory of every establishment importing products into the U.S. Therefore, the FDA can verify if the drugs should be allowed entry into the country.
Although the FDA has a business plan to address its IT systems, additional resources are needed for laboratory and inspection operations. Increases in the budget for inspections would need to be substantial. “They are very inadequate right now. We really do not inspect most of the facilities overseas very much at all,” Woodcock said.
Woodcock’s sentiments were echoed by an April 22 report from FDA Commissioner Andrew von Eschenbach, MD, who told the House Energy and Commerce subcommittee on oversight and investigations that updating its information systems is one of the agency’s top priorities.
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;
- 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.
Woodcock concluded by telling the panel that the FDA needs more authority to pursue violators in the pharmaceutical supply chain.
“The FDA or any other regulator cannot test quality into products, and we cannot inspect quality into products. The FDA must have the tools to hold all these parties accountable,” she said.