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Congress Hears Warnings about FDA

'Growing crisis' in food and drug safety, consumer and industry groups warn

February 27, 2008

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Congress got an earful today as it held hearings on legislation that would provide more funding and authority to the Food and Drug Administration (FDA). Consumer and industry groups said the agency is falling short in its mission to ensure the safety of drug and food products.

The FDA is suffering from a crisis in leadership, a lack of congressional oversight and a dangerous reliance on the pharmaceutical industry to bankroll its operations, Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen, said.

While these problems have existed for years, they have become glaringly obvious in recent weeks with news stories about deaths linked to drugs such as the anticoagulant heparin, which is made in China, and Trasylol, a drug that reduces bleeding during surgery and may be responsible for thousands of deaths a year, Wolfe said.

“The situation at the FDA has never been worse than now,” Wolfe said. “Congress must act quickly to restore confidence in the FDA by removing the considerable influence of the drug industry, which currently funds almost two-thirds of the FDA’s budget for drug approval.”

Wolfe testified before the House Agriculture-FDA Appropriations Subcommittee’s hearing on FDA drug safety.

Since 2002, the FDA’s budget for foreign inspections of drug facilities has decreased 25 percent. This comes at the same time as the number of foreign plants manufacturing drugs for import into the U.S. has rapidly increased, Wolfe said.

While Chinese laboratories account for 22 percent of the foreign facilities that import into the U.S., they were subject to only 4 percent of the FDA inspections last year, Wolfe said.

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Supermarkets and food producers, meanwhile, are calling for stricter regulation of food safety. Grocery Manufacturers Association Vice President Robert Brackett chided both the Bush administration and Congress for not giving the Food and Drug Administration more funding to inspect food at company plants.

"Because FDA food-related funding has not kept pace with inflation, more than 800 scientists, inspectors and other critical staff have been lost in the past four years," said Brackett, a former food safety director at FDA.

Brackett also urged Congress to give FDA the authority to order a company to recall tainted food if the company doesn't volunteer. Currently the agency must work with producers to organize voluntary recalls.

"Waiting on the company to make the decision is like the fox guarding the hen house," said Rep. Diana DeGette, (D-Colo.). "My constituents are shocked to learn that these agencies do not have this authority."

The committee chair, Rep. John Dingell (D-Mich.) said it was "clear our regulatory system is broken."

The “time has passed for half measures,” Dingell said.

The food industry has been plagued by a series of recalls over the past two years, from tainted spinach and peanut butter to E. coli-contaminated beef and botulism in canned foods.

Seafood safety

Also testifying before the committee was John Williams, a shrimp fisherman and executive director of the Southern Shrimp Alliance. He criticized the FDA's reliance on importers to verify food safety.

"The FDA has failed to enforce food safety laws on imported seafood. The FDA's approach to imported food safety is to accept unverified representations from importers with only token inspections," said Williams.

Concerns about the FDA's inability to assure the safety of imported seafood have caused at least eight states to conduct their own testing programs. Repeatedly, these states have found banned substances in the imports they test-seafood allowed by the FDA and the private sector to enter the U.S. market.

Since 2002, the state of Louisiana has had an Emergency Rule in place to test imported shrimp and crawfish for chloramphenicol. It added testing for fluoroquinolones in Chinese and Vietnamese seafood in 2007.

The FDA's failure to prevent the importation of contaminated shrimp has a number of negative effects on the U.S. market, the U.S. shrimp industry and U.S. consumers that benefit from a diet of healthful seafood, Williams said:

• Farmed-shrimp imports contaminated with banned antibiotics, pesticides and other dangerous contaminants put the health of U.S. consumers at serious risk.

• U.S. consumers are quite often unable to distinguish between safe and unsafe shrimp in retail markets and restaurants. Their fear of buying or being served contaminated imported shrimp depresses the overall consumption and demand for all shrimp, including healthful, wild-caught shrimp produced in the United States.

• Finally, the FDA's lax inspection system allows volumes of low-value contaminated shrimp into the U.S. market. These illegal shipments depress the price for U.S. shrimp fishermen, he concluded.

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