Politics / Regulation

Senators Want FDA Action in Collecting More Animal Antibiotics Data

The use of antibiotics in animal food has been an ongoing debate. In 1977, the U.S. Food and Drug Administration (FDA) tried and failed to limit the use of antibiotics in animal feeds. This loss in 1977 helps explain why the agency is so trepid in pursuing any significant action and why clear legislation is still in limbo. However, this past week, four U.S. Senators, Dianne Feinstein (D-CA), Tom Harkin (D-IA), Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA), have called on the FDA to start collecting more animal antibiotics data, a previously proposed rule that had been delayed and set on the back burner of regulatory affairs. Will the FDA listen to the Senators’ plea for increased regulation of antibiotics in animal feed or will the FDA continue to tread lightly after Congress told them no in 1977?

Many scientists hypothesize that the evolutionary origin of resistance genes stems from microorganisms that live in close proximity to antibiotic-producing microbes. This initial emergence in pathogenic populations of resistant bacteria became termed the “smoking gun.” Even though the origin of these antibiotic resistant genes remains pivotal to current research, the main issue is that the bacteria in commercial animals exists as the reservoir for these harmful mutated genes. Farmers and the meat industry became the perpetuators of this climbing controversial issue decades ago when they heedlessly dumped millions of pounds of antibiotics into their animal water and feed.

Antibiotics were administered to entire herds of cattle that showed no sign of sickness, instead of to individual sick cattle because of production costs. Farmers also apply antibiotics to their cattle for weight gain, which is a practice called sub-therapeutic dosages of antibiotics. Excessive antibiotics become a concern because it leads to the emergence of multi-drug resistant pathogens. Even though antibiotics kill off the majority of bacteria in commercial animals, some bacteria remain resilient to the drugs and pass off these traits to their prodigy. These newly mutated strains reproduce rapidly, fighting off the competition of other bacteria.

Stanley Falkow, a young microbiologist at the University of Washington, was one of the first American researchers to present research on the topic in 1970 at the U.S. Department of Agriculture’s research center in Beltsville, MD. Four years later, Falkow joined one of the FDA subcommittees in 1975. In 1977, the subcommittee released a report with a warning that low doses of antibiotics in animals posed a risk to public health and should be banned. This warning spurred into action and the FDA Commissioner Donald Kennedy proposed banning the use of two classes of antibiotics- penicillin and tetracycline- in animal feed. The proposal also included putting veterinarians in charge of prescribing all other antibiotics used on the farm.

While the FDA proposal drew a favorable response from scientists and health professionals, it received considerable opposition from farmers and animal drug makers who voiced that there was no clear scientific evidence and would cause immense financial strain on the lucrative U.S. meat production business. It turns out that the farm lobby had tremendous clout. They had ties to Rep. Jamie Whitten (D-Miss) who was the longtime chair of the subcommittee that controlled the FDA’s budget. Whitten went on to threaten to cut the FDA’s budget if the agency moved forward with the proposed rules.

The FDA Commissioner, Kennedy, was left with no other choice but to halt the proposed regulation, and that is where the efforts remained for decades.

Recent action was finally seen in December 2013, when the FDA came out with a new plan to voluntarily ask pharmaceutical companies to change the label on antibiotics so that growth promotion was no longer allowed. It would also require that all antibiotics be under the supervision of a veterinarian. The major caveat of this plan? The fact that it is voluntary.

FDA Commissioner Hamburg defended her heavily criticized decision to ask drug companies to voluntarily stop selling drugs to farmers solely for growth-promotion by saying that a volunteer basis will expedite the process. However, the drug industry claims that only 12 percent of animal antibiotics are used solely for growth promotion. This leaves 88 percent unaccounted for and the majority of antibiotics will continue to be used as before.

Researchers are saying that despite good intentions and slight movement by the FDA, it’s all for nothing if they don’t start collecting the data to verify that farmers are changing the way they’re using antibiotics. The success of a program without collected data is an oxymoron in itself.

That’s why the FDA should listen to the Senators’ request for the FDA to step up animal antibiotic data collecting. It is a big public health issue that, after four decades, needs to be addressed. The ball remains in the FDA’s court. After years of inaction, maybe it is about time for some regulatory action.

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