Musty FDA Livestock Drug Approvals Come Back to Haunt

Musty FDA Livestock Drug Approvals Come Back to Haunt

Still Using Decades-Old Assessments Lacking Analysis of Known Human Impacts

Washington, DC — In approving new uses for livestock drugs, the U.S. Food & Drug Administration is still relying on decades-old assessments, in many cases with little or no updated review, according to an analysis of agency records by Public Employees for Environmental Responsibility (PEER). These dated drug assessments, some as old as the 1980’s, do not even contemplate a number of well-known adverse effects, such the drugs’ role in growing antibiotic immunity, which FDA now decries with alarm.

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.

Relying on these outdated assessments, the FDA has approved 53 animal drugs for non-therapeutic use through “categorical exclusions” without determining the environmental impact of applying the drugs on the human environment. As a result –

• Many of the antimicrobials, steroids and hormones now commonly used in feedlots and dairies have never been assessed for the impact they have on the human environment. Most of these drugs flow, un-metabolized by the animals, through treatment plants and back into rivers, lakes and our drinking water supplies;
• Many of the old environmental assessments (EAs) do not even address the environmental impacts of drug application on animals, but rather address the environmental impacts of making the drug. For example, an EA written in 1994 for one antimicrobial is just three pages long and only discusses the air quality impacts of manufacturing the drug; and
• A number of drugs approved for use are now approved for use in combination with other drugs with no review of interactive effects. Similarly, some drugs originally approved for use in one species, are now approved for use in another without environmental review.

“Through gross neglect, FDA has helped author a public health nightmare scenario,” stated PEER Counsel Kathryn Douglass, noting that the agency is asking the livestock industry “to phase out production uses of medically important antimicrobials” to prevent them from becoming ineffective due to growing environmental immunity, according to a recent Federal Register notice. “FDA hands out new animal drug application approvals like they are lottery tickets.”

PEER obtained the FDA approval documents through a lawsuit filed under the Freedom of Information Act. Many of the assessments FDA employs today as the basis for approving new animal drug applications pre-date the advent of its website.

“FDA is clinging to patent medicine approaches to confront new age public health threats,” Douglass added. “The agency must start applying the volumes of scientific information it has acquired in making regulatory decisions rather than leaving it sit on a shelf.”

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See the fact sheet on FDA approvals

View the growing pharmaceutical threat from livestock drugs

Look at FDA’s failed attempt to secure voluntary reductions by industry