FDA Being Sued for Endangering Public Health

MANHATTAN (CN) – A supine Food and Drug Administration is allowing the use of low doses of antibiotics in animal feed to deal with cramped and unsanitary conditions on cattle farms, according to the Union of Concerned Scientists and four other groups, raising the “specter of untreatable infections” just around the corner.

The Natural Resources Defense Council, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists sued the U.S. FDA and its Commissioner Margaret Hamburg, the Center for Veterinary Medicine and its Director Bernadette Dunham, and the Department of Health and Human Services and its Secretary Kathleen Sebelius.

The watchdog groups say the FDA first approved feeding of “preventative” antibiotics to healthy livestock in the 1950s. 
But in 1977, the FDA found that found that “subtherapeutic” doses of penicillin and tetracyclines – at levels too low to treat disease – contributed to development of antibiotic-resistant bacteria that could be transferred to humans.

“This litigation does not concern targeted, short-term uses of antibiotics to treat animals that are already sick,” the complaint states.

The nonprofits say that the FDA never retracted its 1977 study, and later research confirmed its findings. Drug resistance is a fact of life for virologists and public health workers, who, for example, must design new forms of influenza vaccine each year to try to counter the diseases’ ability to survive old forms of vaccines and drugs.

“The misuse and overuse of antibiotics has given rise to a growing and dangerous trend of antibiotic resistance,” the complaint states. “Increasingly, bacteria are resistant to not one but multiple antibiotics, resulting in infections that are difficult to treat, require longer and more expensive hospital stays, and are more likely to be fatal. The Institute of Medicine of the National Academy of Sciences has warned that ‘[t]he specter of untreatable infections – a regression to the pre-antibiotic era – is looming just around the corner.’”

In 1999, four of the plaintiffs submitted citizen petitions asking the FDA to withdraw its approvals for nontherapeutic uses of antibiotics in livestock if the antibiotics are also important in human medicine.

The fifth plaintiff, the Natural Resources Defense Council, joined in 2005.

The nonprofits say the FDA “unreasonably delayed ruling on” these petitions, and “has never issued a final response to either petition.”

But the scientific evidence is overwhelming, the groups say.

“Approximately 80 percent of all antibiotics used in the United States today are used in livestock. Most of these drugs are not used to treat disease. Instead, they are given to healthy animals in their feed or water, both to promote faster growth and to prevent infections that tend to occur when animals are kept in cramped, unsanitary conditions. Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be – and have been – transferred from animals to people through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products.”

The FDA’s failure to act, and to respond to the petitions, violates the Administrative Procedure Act and the Food and Drug Act, the groups say. 
They want the FDA ordered to withdraw its approval of subtherapeutic uses of penicillin and tetracyclines in animal feed.

They are represented by Mitchell S. Bernard from the Natural Resources Defense Council.

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