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For Immediate Release: Oct 17, 2012
Contact: Kirsten Stade (202) 265-7337

VOLUNTARY LIVESTOCK DRUG WITHDRAWAL PROSPECTS ILLUSORY

FDA Wishful Strategy of Corporate Cooperation to Stem Growing Drug Resistance


Washington, DC — The current approach by the U.S. Food & Drug Administration to rely upon a voluntary industry phase-out of antimicrobial drugs in livestock feed is unlikely to work, according to internal FDA memos posted today by Public Employees for Environmental Responsibility (PEER). Beset by lawsuits, the agency is hoping that issuing voluntary guidance to livestock owners, drug companies and veterinarians will stave off judicial intervention.

An estimated 70,000 Americans die each year from drug-resistant infections, ranging from salmonella to staph. The rise of drug-resistant “super diseases” is driven by overuse and misuse of antimicrobial drugs in livestock feed primarily to promote livestock growth. Each year, 30 million pounds of these drugs are pumped into feed troughs, representing approximately 80% of total antimicrobial use.

FDA claims that it is working successfully with industry “to phase out production uses of medically important antimicrobials,” according to a December 2011 Federal Register notice announcing that the agency would not pursue regulatory action. PEER asked the agency under the Freedom of Information Act (FOIA) for the evidence behind its stated confidence that “the animal pharmaceutical industry is generally responsive to the prospect of working cooperatively with the Agency.”

When FDA failed to respond to this FOIA request, PEER sued the agency on July 3, 2012. In recent weeks, FDA has begun to produce relevant records but rather than supporting the agency position on volunteerism, the documents contradict it:

  • One strategy memo states “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…to measure the effectiveness of the strategy.” Another memo states “If the voluntary approach does not achieve our goals, there are several regulatory options available to us.” But FDA blanked out what those “regulatory options” are;
  • A top FDA official emails his frustration that industry public statements “make no reference to the fact they are working with FDA…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.”; and
  • Another memo concedes a court ruling that “an entirely voluntary approach to the regulation of antimicrobial animal drugs is unlawful” but hopes a statement that if there is no progress in three years “the agency will consider further action as warranted” will “assuage the court’s concern.”

“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.”

The PEER suit is also seeking copies of any environmental assessments FDA conducted before approving an array of animal pharmaceuticals for sub-therapeutic uses.

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Read three FDA internal strategy memos

View internal emails

Revisit the PEER FOIA suit