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

This summer federal lawmakers are hoping to enact two pieces of legislation that would give the Food and Drug Administration (FDA) more authority and funding to better regulate the safety of domestic and imported foods.

A House bill, the Food and Drug Administration Globalization Act of 2008, would grant the agency authority for mandatory registration, certification, and inspection of all food facilities. To pay for the extra resources needed to carry out these new responsibilities, the measure would also impose $600 million in new annual food industry user fees.
“Rather than continuing to simply react to outbreak after outbreak of contaminated products, it is about time that we put in place a stronger and more thorough system to prevent contaminated food products from reaching store shelves,” says Rep. Frank Pallone Jr. (D-N.J.), chairman of the House Committee on Energy and Commerce’s Subcommittee on Health and one of the bill’s sponsors.

The bill was crafted with input from industry, regulators, and policy analysts. Three hearings on the draft measure were held earlier this year, and the House Energy and Commerce Committee is pushing to finalize the bill and bring it to a full floor vote this summer, committee spokeswoman Brin Frazier tells Food Quality. “The goal is to strengthen the FDA and ultimately protect consumers,” Frazier says.

Implications for Industry

But not everyone is pleased. Among other things, the bill would require all food facilities in the United States to register with and pay a $2,000 annual fee to the FDA. Food importers would pay $10,000 annually.

“We strongly oppose food taxes and ‘fees’ that are not tailored to provide a government service to our industry,” says Cal Dooley, president and chief executive of the Grocery Manufacturers Association. Increased FDA resources, he told lawmakers in April, should come from congressionally appropriated funds, not user fees.

The bill would also require that foreign and domestic food facilities establish safety plans to identify and mitigate hazards; the FDA would review these plans during mandatory inspections every four years. Facilities wishing to certify that they are meeting all applicable safety requirements could voluntarily seek documentation from FDA-accredited certifying agents.

Dooley objects to third-party certification, saying it would “improperly delegate FDA responsibilities.” Others argue that independent certifications are essential if the FDA is to maintain an arms-length distance from the entities it regulates. Granting a “government stamp of approval creates a commonality of interest between the agency and the company and erodes the independence and objectivity of the agency,” says Michael R. Taylor, professor of health policy at the George Washington University School of Public Health and Health Services in Washington, D.C. “FDA should accredit certifiers but not grant certification itself,” says Taylor, who is also a former administrator of the U.S. Department of Agriculture’s Food Safety and Inspection Service.

Dooley is also critical of the idea that FDA inspectors would have broad authority to review the adequacy of food safety plans, mandate specific controls, and establish performance standards for facilities. While supporting the requirement of safety plans for food companies, he maintains that companies “should be given the discretion to identify appropriate safety controls and measures.” And giving the FDA power to assign fees and fines, Dooley says, “will create a powerful incentive for the FDA to find violations regardless of merit.”

A separate issue under debate is granting subpoena power to the FDA. The FDA’s only current recourse when attempting to obtain critical data being withheld is to threaten criminal prosecution by the Justice Department.

Show Me the Money!

Also pending in Congress is a measure that would give the FDA an immediate $275 million boost in spending to bolster inspections of food products and pharmaceuticals manufactured abroad. Of this, about $119 million would be allocated for food safety issues.