Beefing Up the FDA: Lawmakers Seek to Give agency More Authority and Funding

“The FDA needs to get its house in order on food and drug safety, and these funds are targeted to do just that,” said Sen. Herb Kohl (D-Wis.), ranking member of the Senate appropriations panel that oversees the FDA’s budget.

After prodding from lawmakers, FDA Commissioner Andrew C. von Eschenbach, MD, told the Senate in May that the agency could use an immediate infusion of $275 million this year, of which $125 million would be dedicated to food safety, $100 million to drugs, devices, and biologics, and $50 million to modernize FDA’s science and information technology systems.

The Senate took Dr. von Eschenbach at his word and included these amounts in a measure that was part of a $165 billion Defense Department supplemental appropriations bill. The Senate approved the massive bill in May, but it would also have to pass the House before it could be signed into law. President Bush had threatened to strike down the measure since it exceeded his domestic spending limits sets the stage for a likely veto battle later this year. But in early June, the administration announced the additional $275 million would be added to its overall Fiscal 2009 request for the FDA, setting the stage for approval without a fight.

The FDA’s own board of scientific advisers and others say the agency requires far greater resources, however. “The nation’s food supply is at risk,” the FDA’s Science Board concluded in a November report. While noting that advocates like the Coalition for a Stronger FDA are urging an additional $250 million to promote food safety, the Science Board stated that even this amount may not be enough.

Struggling to Stay Safe

These legislative efforts come as the FDA struggles to implement food safety requirements mandated in the Food and Drug Administration Amendments Act of 2007 (PL 110-85), which was signed into law in September, as well as the agency’s own Food Protection Plan, announced in November.

Mindful of 2007’s Chinese melamine contamination, the former requires, among other things, that the FDA establish a food registry and notification system to respond to adulterations of human and pet foods. The latter focuses on three core elements intended to secure the safety of both imported and domestic foods:

• Prevention based on corporate responsibility for risk reduction;
• Intervention focused on risk-based inspections, sampling, and surveillance at high-risk points in the supply chain; and
• Response, including improved communication and coordination with other government agencies and industry during and after emergencies.

“The plans seek to build in safety measures across a product’s life cycle, from the time a food is produced to the time it is distributed and consumed,” says Stephen F. Sundlof, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.

The task is daunting. The FDA oversees about 80% of the U.S. food supply, including $417 billion in domestic food and $49 billion in imported food annually, according to the Government Accountability Office, the investigative arm of Congress. There are 44,000 food manufacturers and processors, 114,000 food retailers, and 935,000 restaurants in the country. According to the Centers for Disease Control and Prevention, 76 million Americans get sick annually due to unsafe food products; 325,000 of them will be hospitalized, and 5,000 will die from foodborne hazards.

Recent outbreaks of Escherichia coli in spinach, Salmonella in peanut butter, and melamine contamination of pet food and other food products highlight some vulnerabilities. “All of this raises questions about our current food safety laws, many of which were enacted in the 1900s,” Rep. Pallone says. “Obviously, laws that were written in the early 20th century are no longer current, particularly as the food industry becomes increasingly more global.”