FDA Requests $275M To Ensure Safety Of Imported Medical Devices, Drugs, Food

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Medical Devices;  Pharmacy / Pharmacist;  Public Health
Article Date: 15 May 2008 - 5:00 PDT

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FDA Commissioner Andrew von Eschenbach in a May 5 letter to Congress requested an additional $275 million in funding to ensure the safety of imported food, prescription drugs and medical devices, the New York Times reports.

According to the Times, von Eschenbach was responding to a May 1 letter from Sen. Arlen Specter (R-Pa.), a member of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, requesting information on the amount of additional funding FDA would need "to protect the public's health." In that letter, Specter wrote by hand in the margin, "Andy, I know the situation is extreme. I want to get you financial help now," the Times reports.

Von Eschenbach wrote that FDA could absorb an additional $275 million within the next few months. Von Eschenbach last month at a Senate hearing said he did not think the agency would in one year be able to absorb $375 million in additional funding included in FDA's 2009 allocated budget. The letter also outlined the expenses for a number of planned initiatives, such as opening new agency offices abroad, increasing the number of inspections and establishing new databases to track drug hazards.

According to the Times, von Eschenbach's funding request "mirrors" a measure introduced by appropriations subcommittee chair Sen. Herb Kohl (D-Wis.) last week as part of an emergency supplemental spending bill for the Iraq war (Harris, New York Times, 5/14). Kohl's measure included $275 million for FDA -- $125 million for food safety; $100 million for medication and medical device safety; $40 million to modernize FDA science and the agency work force; and $10 million to upgrade FDA facilities and laboratories (Kaiser Daily Health Policy Report, 5/8).

Letter Details
In his letter, von Eschenbach wrote that he was offering the spending plan "without regard to the competing priorities that the agency, the president and their advisers must consider as budget submissions to the Congress are developed." According to the Times, the letter request "surprised agency observers" and could be a "sign of the president's waning influence" in the final months of his term. William Hubbard, a former deputy FDA commissioner, said, "In 30 years at the agency, I never saw anything like this happen before."

Comments
FDA spokesperson Julie Zawisza said, "These resources will accelerate the changes required for FDA to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical products."

Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, said, "We are one step closer to an FDA that has the resources to serve the needs of American consumers."

House Energy and Commerce Committee Chair John Dingell (D-Mich.), who has proposed drug safety draft legislation, said he was curious about "why the commissioner is beginning to finally recognize what has been painfully obvious to everyone else" (New York Times, 5/14).

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