FDA Documents Show Internal Concern About Voluntary Antibiotics Approach

By Helena Bottemiller | October 24, 2012 Internal U.S. Food and Drug Administration documents recently made public show that the agency has some concern over whether its voluntary approach will successfully reduce the non-judicious use of antibiotics in food animal production. The memos and emails, posted online last week by Public Employees for Environmental Responsibility (PEER), provide a small window into the deliberation over FDA's current approach. The group said it had to sue FDA for the documents after the agency failed to respond to a Freedom of Information Act request. As concern grows about agriculture's role in fueling antibiotic resistant 'superbugs,' FDA has maintained that it's more expedient to work collaboratively with the animal drug industry than to withdraw certain antimicrobial drugs, because the latter can be a long and expensive process. To help curb the non-judicious use of antimicrobials, the agency is asking drug companies to voluntarily change their labels for certain drugs so that farmers are only able to use them under veterinary supervision, instead of obtaining them over-the-counter, and only to prevent, control or treat diseases while not using them to promote growth or improve feed efficiency. But in an August 2011 memo, marked privileged and confidential, the agency admits that there are potential drawbacks to this approach: "We recognize 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, as noted by GAO in their latest and not yet published report, to measure the effectiveness of the strategy." (The GAO report has since been published.) The memo goes on to discuss additional options, if the voluntary approach fails, but the discussion is redacted. A September 2012 memo, also marked privileged and confidential, indicates that there was internal discussion about just how much FDA should foreshadow potential regulatory action, if the voluntary approach were to fail, in its communications with industry and the public. The memo apparently lists "available regulatory actions," but the discussion is redacted. One email from Bill Flynn, the Deputy Director of Science Policy at FDA's Center for Veterinary Medicine, expresses concern about the industry-funded Animal Health Institute's public support of FDA's voluntary, collaborative approach. The email responds to a forwarded message from AHI's Alexander Mathews that lays out the group's response to a recent Natural Resource Defense Council lawsuit. "We've consistently said that policy decisions about the use of antibiotics in animals should be made on the basis of careful scientific risk assessment," reads the email from Mathews. "Several risk assessments measuring the risk of various antibiotic compounds used in animal agriculture have been published in peer reviewed journals, and they uniformly find the risk to public health to be vanishingly small." "I find this response from AHI to be very problematic," writes Flynn. "They make no reference to the fact that they are working with 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 industry will not work." PEER said it originally filed the FOIA request seeking evidence to back up the agency's statement that "the animal pharmaceutical industry is generally responsive to the prospect of working with the Agency." The group said it believes the memos and emails released contradict instead of support FDA's approach. "These 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," stated PEER Counsel Kathryn Douglass who filed the FOIA suit. "In the foot-thick stack of materials FDA surrendered there is not a shred of evidence that industry is working to phase-out injudicious use of these drugs." See: FDA Issues Voluntary Plan to Limit Antibiotics in Agriculture © Food Safety News More Headlines from Food Politics » Tags: antibiotic resistance, antibiotics, FDA, Public Employees for Environmental Responsibility