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CU supports the “FDA Globalization Act of 2009”

February 6, 2009
Honorable John Dingell
U.S. House of Representatives
2328 Rayburn Building
Washington, DC 20515
Honorable Frank Pallone, Jr.
U.S. House of Representatives
237 Cannon Building
Washington, DC 20515
Honorable Bart Stupak
U.S. House of Representatives
2352 Rayburn Building
Washington, DC 20515
Dear Chairmen Dingell, Pallone, and Stupak:
Consumers Union, the non-profit publisher of Consumer Reports, is writing in support of your legislation, the “FDA Globalization Act of 2009.” The U.S. food, drug, device, and cosmetics safety system has been in trouble for a long time; the most recent examples of its failings in the food safety arena are the current outbreak of salmonella in peanut butter, which has killed 8 and sickened over 500, and last summer’s outbreak of salmonella in peppers imported from Mexico. A little over a year ago, contaminated heparin from China sickened hundreds, and is estimated to have contributed to the death of about 200 patients. There are many other examples that demonstrate that the U.S. Food and Drug Administration (FDA) – the agency that is supposed to oversee the safety of an enormous array of consumer products, from peanut butter to heart medication, and many others – is not adequately protecting Americans. Building upon the landmark reforms in the 2007 Food and Drug Administration Amendments Act (FDAAA), which you all achieved, the FDA needs additional significant overhaul.
Your legislation includes several critical provisions that will accomplish significant reform of this beleaguered agency. Among those reforms, your bill will require that all food and drug manufacturing facilities – both foreign and domestic – register with the FDA. This provision will ensure that the agency is able to identify the scope and composition of the industries it is charged with regulating, and will enable the agency to contact responsible individuals especially when safety problems arise. A requirement for traceability in electronic form will help FDA to determine the source of disease outbreaks more quickly and easily. In addition, the requirement that food and drug facilities maintain hazard analyses and safety plans will help to keep dangerous products from reaching the market in the first place.
Further, the registration fee system established by your legislation will fund the important inspection and safety-related work of the agency. The needs of the agency are great, and funds are in short supply. While fees should not supplant regular appropriations, these fees will help the agency perform long-overdue regular, mandatory facility inspections on a frequent basis. A substantial increase in the penalties that wrongdoers will have to pay will also help to ensure that violations do not simply constitute a “cost of doing business,” and will help to deter those who would seek to put unsafe products into our food and drug supply.
The current outbreak of salmonella in peanut butter – only two years after a similar outbreak from another Georgia peanut butter factory – highlights the need for a few additional reforms which we urge you to consider. Congress should mandate inspections of food facilities at least once a year, and require companies and state agencies to report any test results showing contaminants to the FDA in a timely fashion. Further, in order for consumers to better protect themselves and their families, recall notices should also be improved to include all of the locations where consumers may have encountered unsafe food or drugs.
For far too long, the FDA has come up short in keeping Americans safe from the foods and cosmetics they use every day, and the medications and devices they rely on to make them healthy. Your bill makes critical, long-needed changes to reform the agency. We thank you for your leadership on this issue, and look forward to working with you to help enact strong FDA reform legislation.
Jean Halloran
Director, Food Policy Initiatives
Consumers Union
101 Truman Avenue
Yonkers, NY 10703
Ami V. Gadhia
Policy Counsel
Consumers Union
1101 17th Street NW, Suite 500
Washington, DC 20036
Bill Vaughan
Senior Policy Analyst
Consumers Union
1101 17th Street NW
Suite 500
Washington, DC 20036