Additional Funds Allow Agency to Open Two Overseas Offices, Hire 119 Inspectors

WASHINGTON, DC -- Today, Senator Herb Kohl (D-WI), Chairman of the Senate Appropriations Subcommittee with jurisdiction over the Food and Drug Administration (FDA), boosted funding for the agency by an additional $275 million in the Senate version of the emergency supplemental appropriations bill. This funding is in addition to the increase of nearly $150 million provided during the 2008 Agriculture Appropriations bill, bringing the total FDA funding increase in 2008 to nearly $425 million.

"With serious concerns about the FDA lacking the resources to do its job, this much needed increase in funding means the agency can hire more food inspectors, open offices overseas, expand data collection and take other necessary steps to prevent our food and drug safety being severely compromised," said Kohl, who chairs the Senate Agriculture, Rural Development, and Related Agencies Appropriations Subcommittee.

"I thank Chairman Byrd for his leadership in recognizing the need to provide additional resources to the FDA so it can fulfill its responsibilities and protect our citizens."

Of the total funding in the bill, $125 million is for food safety activities; $100 million is for medical product and drug safety activities; $40 million is for modernizing FDA science and the FDA workforce; and $10 million is to upgrade FDA facilities and laboratories outside of Washington, DC, which are currently below public safety standards and incapable of performing agency requirements.

In April, Senator Kohl held a Senate Appropriations Subcommittee hearing with FDA Commissioner Dr. Andrew von Eschenbach and other agency officials as witnesses to address budget-related issues affecting severe staffing, research and technology deficiencies within the agency, which have resulted in a perceived and real inability for the FDA to protect the American food and drug supply. The funding level and specific activities included in the Senate versions of the Supplemental were provided by the FDA and identified as highest needs activities that they could immediately begin to implement.

Specifically, this funding will allow the FDA to: • Open FDA offices in two additional countries.

• Identify and collect data to conduct risk-based prevention activities, as well as develop tools to identify the source and cause of food borne illness outbreaks more quickly and trace the distribution of contaminated products. The extensive 2006 spinach recall, due to E. coli, that sickened 205 people and resulted in 3 deaths highlights the importance of this funding.

• Allow FDA to conduct an additional 20,000 import food exams at ports of entry; 150 more foreign food facility inspections; and 1,000 more domestic food safety inspections.

• Hire an additional 119 food safety inspectors.

• Implement many new drug safety initiatives, including pediatric drug and device safety, post-market study commitments, and improved drug surveillance and labeling, as required by the recent Food and Drug Administration Amendments Act.

• Improve FDA's IT systems to improve drug safety, including more rapidly identifying adverse drug events.

• Conduct 120 more foreign medical product facility inspections, 575 more domestic medical product inspections, 10,000 additional medical product import exams; and an additional 300 lab analysis of imported medical products. The recall this spring of the contaminated blood thinner Heparin from China, which has resulted in 81 deaths so far, underscores the need for these additional dollars.

• Hire an additional 99 medical product safety inspectors.

• Expand science training for FDA employees; and strengthen FDA's science programs to allow them to effectively regulate new and complex products.

Senator Kohl vowed to continue holding the FDA accountable, and will require quarterly reports on the status of these funds.

"As chairman of the Appropriations panel with oversight of the FDA, I will continue to monitor the agency's progress in implementing these critical improvements," Kohl added.