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• If FDA is 'Broken,' Why is Congress Focused on Adding Tobacco Regulation to the Agency Rather Than Ensuring the Safety of Food, Drug and Medical Devices in the United States? 

Despite the recognition of the need to address these issues, Congress is focused on legislation to expand FDA's responsibilities to include tobacco products with a new regulatory bureaucracy funded by more than $7 billion in new fees and taxes. The House Committee on Energy and Commerce is expected to consider the legislation within the next several weeks.

"This raises the question of congressional priorities: should they be working to ensure the safety of food, prescription drugs and medical devices, or considering additional regulations on tobacco products, paid for by billions in new taxes and fees?" said Tommy J. Payne, executive vice president of public affairs for Reynolds American Inc.

"The FDA commissioner raised serious concerns with this legislation in testimony submitted to Congress last fall. The commissioner expressed concern that the bill may require the agency to divert funds from other programs like the safety of drugs and food; that it could undermine the public-health role of FDA; that the public might believe that products 'approved' by FDA are safe and that this will actually encourage individuals to smoke more rather than less; and finally, that the bill requires the agency to perform functions that are outside of its expertise," Payne said.

Payne also questioned the wisdom of adding $7.6 billion in new taxes and fees to support a huge new bureaucracy in Washington at this time.

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