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Washington, DC - Today, Reps. John D. Dingell (D-MI15), Chairman Emeritus of the Committee on Energy and Commerce; Frank Pallone, Jr. (D-NJ06), Chairman of the Subcommittee on Health; and Bart Stupak (D-MI01), Chairman of the Subcommittee on Oversight and Investigations, introduced the Food and Drug Administration Globalization Act of 2009. This legislation is a critical step toward equipping the Food and Drug Administration (FDA) with the authorities and funding it needs to regulate what is now a global marketplace for food, drugs, devices, and cosmetics.
The Food and Drug Administration Globalization Act would guarantee FDA the funding needed to significantly increase inspections of food facilities and improve outdated information systems. The legislation requires food producers to have preventive food safety plans in place and subjects the plans to FDA inspection, requires food imports to meet all US standards, closes the loopholes in FDA's ability to trace the source of contaminated products, and imposes stiff penalties on companies that violate safety standards.
Additionally, this bill requires parity between foreign and domestic drug and device facility inspections, increases the number of pre-approval drug inspections, prohibits the entry of drugs into the United States lacking documentation of safety, requires manufacturers to ensure the safety of their supply chain, and grants FDA authority to mandate recalls of unsafe drugs. The bill also creates a dedicated foreign inspectorate to increase FDA’s ability to monitor foreign facilities producing food, drugs, devices, and cosmetics.
“Antiquated authorities and years of starving FDA of resources has put the public health at risk. Every few months brings another crisis—E. Coli in spinach, contaminated heparin, tainted peppers, and now salmonella in peanut butter that has killed eight people and sickened more than 483 people. The time to act is now,” stated Rep. Dingell.
Rep. Dingell also stated, “Americans shouldn’t have to worry about whether the food they serve their families and the medical products they use to improve their health might actually make them sick. I urge the Committee to take swift action to prevent additional illness and death. I look forward to working with my House and Senate colleagues, President Obama, and stakeholders to address these pressing issues. I also look forward to continued discussions on additional improvements to the drug supply through pedigree systems.”
Rep. Pallone said: “Today, the FDA is not properly equipped to inspect food, drugs, devices and cosmetics. As witnessed by the latest salmonella outbreak, the Peanut Corporation of America's outrageous actions show that food manufacturers cannot be trusted to self-regulate. This comprehensive legislation provides FDA with the funding and the authorities necessary to ensure that it can once again fulfill its mission to keep Americans safe.
“In the last two weeks, GAO has released two reports that highlight glaring inadequacies in the agency. In the coming weeks, I plan to hold hearings in my subcommittee to examine these problems in further detail, starting with medical devices. I look forward to working with my colleagues and the new administration to get this legislation passed into law,” Pallone concluded.
Rep. Stupak added: “Since January 2007, my Oversight and Investigations Subcommittee has held 16 hearings on the FDA’s failure to protect Americans from unsafe food and drugs,” Stupak said. “The Food and Drug Administration Globalization Act addresses many of the problems we have indentified through our hearings, providing the regulatory tools and financial resources for the FDA to protect American families from unsafe food and drugs. Congress faces an ambitious agenda in the coming months, but the more than 500 illnesses and eight deaths linked to the current salmonella outbreak underscore the importance of wasting no time in enacting this important legislation.”
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