FDA Privately Doubts Own Voluntary Veterinary Drug Guidelines

For decades the Food and Drug Administration (FDA) did little to regulate the use of antibiotics in factory farms opting instead to work with the industry. It claimed that “the animal pharmaceutical industry is generally responsive to the prospect of working cooperatively with the Agency” on phasing out the “production uses of medically important antimicrobials.” Public Employees For Environmental Responsibility (PEER), a non-profit environmental watchdog group, set out to test the strength of the agency’s belief in the voluntary approach.

The FDA’s voluntary approach to regulating the use of antibiotics in factory farms is criticized by many consumer and health advocates.  After all, no regulations means no violations or sanctions should players in the industry fail to comply.  Last year, PEER filed a Freedom of Information Act (FOIA) request seeking documents that would demonstrate the effectiveness of the FDA’s voluntary approach.

Evidence linking antibiotic resistance in humans to overuse of antibiotics in factory farms used primarily to promote animal growth, counter the adverse effects of over crowded and poorly sanitized living conditions — not to treat illness — has been mounting for decades. The FDA recognized the problem more than four decades ago, attempted to address it in 1977, but ultimately took little definitive action until this April when the agency clarified its voluntary guidance to animal producers and sought new input from drug manufacturers without taking regulatory measures.  Another watchdog group, the Natural Resource Defense Council, took the FDA to court on this issue nearly a year ago.

By FDA’s recent estimates, factory animals are drugged to the tune of 28.8 million pounds of antibiotics a year or nearly 80% of all antibiotics sold in United States.

When the FDA failed to produce documents sought by PEER, the non-profit sued for their release. PEER discovered that FDA’s internal documents reveal cracks in the agency’s public confidence as to the effectiveness of the voluntary approach to dealing with the livestock industry. For example, an agency memo revealed that the FDA “recognizes that the voluntary strategy has certain limitations in that (1) it lacks specifically defined/mandated timeframes; (2) its success is dependent on drug sponsors deciding it is in their best interest to work cooperatively with the agency; and (3) FDA collects insufficient data on drug use…to measure the effectiveness of the strategy.” The memo proposes “options” to deal with these limitations but they have been redacted prior to release of the documents.

Similarly, an email from a senior FDA official expressed dissatisfaction with an industry press release stating that: “I find this response from [Animal Health Institute] to be very problematic. They make no reference to the fact that they are working with the FDA to address this issue. They simply refer to the fact that the risk is “vanishingly small” and that the products are approved by FDA and are therefore safe (i.e.  there is no problem). This type of position just reinforces the idea that legislation (or perhaps a lawsuit) is needed because FDA’s plan to work with the industry will not work.”

In a press release, PEER Counsel Kathryn Douglass said that “[t]hese documents show that FDA’s public health strategy is to whistle past the graveyard, as more people are pushed beyond the help of medically vital drugs.”