Report: The FDA completely dropped the ball on antibiotic resistance

The agency knowingly allowed drugs that pose a high risk to humans to be used on farm animals

Published January 28, 2014 2:43PM (EST)

In December, the U.S. Food and Drug Administration took its "boldest" step yet in regulating the overuse of antibiotics in livestock -- an industry trick to fatten up animals that's also contributing to the rising prominence of antibiotic-resistant superbugs in humans. The agency released new guidelines that would limit the drugs' use to cases where animals were actually sick, and only then with a note from the vet.

It had good reason to act: 80 percent of the antibiotics produced in the U.S. end up being fed to livestock, and very real human health consequences come along with that fact. Elsewhere in the federal government, the Centers for Disease Control and Prevention inform us that at least 2 million people in the U.S. become infected with antibiotic-resistant bacteria each year, and at least 23,000 die as a direct result. But lest it appear too urgent about all that, the FDA made Big Pharma's compliance with the new guidelines voluntary.

Now, new information reveals that the agency's lack of concern about widespread antibiotic use goes even deeper. The FDA's own internal review of 30 antibiotics found that over half of them had the significant potential to expose humans to antibiotic resistant through food. The other 12 could be dangerous as well -- the agency didn't have enough information to decide for sure. And despite that information, 28 of the drugs remain approved (the two that aren't were pulled by their manufacturer); at least nine are still on the market today. It's impossible to know how widely used they are, because the FDA doesn't release the data for specific drugs.

The review was brought to light by a FOIA request from the Natural Resources Defense Council, which published a report on its findings. “This discovery is disturbing but not surprising given FDA’s poor track record on dealing with this issue," Carmen Cordova, a NRDC microbiologist and the lead author of the report, said in a statement. "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.”

Time's Brian Walsh lays out the FDA's decades-long failure to act:

The FDA has been looking at antibiotics in farm animals since 1970, when the agency convened a joint task force of experts that eventually found that the nontherapeutic use of antibiotics in livestock—meaning for growth promotion or for prophylactic use on healthy animals—could lead to resistant strains of bacteria that could threaten human health. In 1973, the FDA adopted regulations that required drug manufacturers to prove the safety of antibiotics used in animal feed and water. In 1977 the FDA found that the use penicillin and tetracyclines—two classes of antibiotics that are widely used to treat humans—in animal feed was unsafe, and proposed to withdraw approval of the drug classes. But according to NRDC’s findings, the agency never followed through.

In 2001, prompted by legislation that set aside money for the agency to look at antibiotics, FDA experts began reviewing livestock feed additives already in use that contained penicillin or tetracyclines. The additives—30 altogether—were reviewed according to two sets of criteria: the 1973 safety regulations, and 2003 guidelines meant to evaluate the safety of any new animal antibiotic drugs. (The 2003 guidelines gauged the risk of antibiotics in feed leading to resistant strains of bacteria, as well as the chance those strains can reach people and damage human health. The antibiotics would then be classified as low, medium or high risk.) The internal FDA documents unearthed by the NRDC show that agency experts found that 26 of the 30 additives had never even met the initial 1973 safety criteria. The agency also found that 18 of the 30 additives posed a “high risk” of exposing human beings to antibiotic-resistant bacteria through the food chain, according to the criteria set out by the 2003 guidelines.

The FDA insists it's dealing with the problem, responding in a statement that it expects to fully implement the voluntary phase-out within three years. "The FDA is confident that its current strategy to protect the effectiveness of medically important antimicrobials, including penicillins and tetracyclines [the specific drugs called out in the NRDC report], is the most efficient and effective way to change the use of these products in animal agriculture," a spokesperson said. Unfortunately, no one else seems to be.

By Lindsay Abrams

MORE FROM Lindsay Abrams

Related Topics ------------------------------------------

Antibiotic Resistant Bacteria Fda Livestock Meat Industry Pharmaceuticals Superbugs