FDA Antibiotic Report: What They Knew Could Hurt Us

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The Food and Drug Administration (or, FDA) has known for years about the potential harm of antibiotics used by farmers, and chose to take a course of quiet inaction. A report by the National Resources Defense Council (or, NRDC) published Monday states that the agency reviewed 30 penicillin and tetracycline antibiotic feed additives between 2001 and 2010. None of the additives reviewed by the FDA would pass current regulations, and 26 failed to meet standards passed in 1973.

The NRDC obtained the information for its report through a Freedom of Information Act request. The FDA documents are the result of scientific reviews by the Microbial Food Safety Team. In addition to failing to meet established standards, 18 of the 30 under review “pose a ‘high risk’ of exposing humans to antibiotic-resistant bacteria through the food supply.”

It does not appear that the FDA took any action regarding its own report. There was no evidence provided by the FDA of how widespread the use of the additives is. At least nine are being marketed for use today, and only two have been removed from the market. The latter action was a voluntary withdraw by the manufacturer.

Rather than focusing on the commonality of the additives, the NRDC is more concerned about the bigger picture. Particularly, the fact that, “FDA data indicate that the types of antibiotics in the reviewed additives — tetracyclines and penicillins — together make up nearly half of all the antibiotics used in animal agriculture.” Other additives to feed, and the generic versions of those tested would have a similar profile, and also be capable of generating antibiotic resistance. “This risk was recognized by FDA in 1977 when it proposed to withdraw approvals for animal feed additives containing penicillin and most tetracyclines,” the report states.

“The evidence is clear. Drugmakers never proved safety. And FDA continues to knowingly allow the use of drugs in animal feed that likely pose a ‘high risk’ to human health. That’s a breach of their responsibility and the public trust,” Carmen Cordova, NRDC microbiologist and lead author of the new NRDC analysis said in a press release. “This discovery is disturbing but not surprising given FDA’s poor track record on dealing with this issue. It’s just more overwhelming evidence that FDA — in the face of a mounting antibiotic resistance health crisis — is turning a blind eye to industry’s misuse of these miracle drugs.”

The “miracle drug” aspect of antibiotics is a double edged sword. The NRDC credits it for taking illnesses and infections that were once fatal, and creating an easy treatment option. However, its glory is also its downfall. As antibiotics became more commonplace, overuse and misuse began breeding resistance. Bacterium can quickly multiply, if it mutates into a form able to withstand the antibiotic meant to kill it, it can create a population of antibiotic-resistant bacteria by passing the trait along.

Penicillin is considered critically important by the World Health Organization, and tetracyclines are highly important. In the U.S., 44 percent of antibiotics sold for human use in 2011 were penicillins, and 3.5 percent were tetracyclines. The human medical use of antibiotics is dwarfed by that of livestock. It is estimated that 70 percent of “medically important antibiotics” sold in the U.S. are for livestock.

The FDA has realized the potential problem this poses, which is why it has issued a voluntary action plan. It calls for the phasing out of certain antibiotics when used to enhance food production, or to meet other non-therapeutic goals. “We need to be selective about the drugs we use in animals and when we use them,” William Flynn, DVM, MS, deputy director for science policy at FDA’s Center for Veterinary Medicine said when the decision was announced. “Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”

Due to the program being entirely voluntary, it does not go far enough for the NRDC. The organization wants the FDA to only use the drugs when treating sick animals, or in order to control outbreaks of disease. It also wants the approval withdrawn when it has been demonstrated that antibiotics previously approved for non-therapeutic use is not safe. Absent FDA action, the NRDC says Congress, consumers, and the food industry needs to demand results.

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