The Court wrote:
“[T]he statutory scheme requires the Agency to ensure the safety and effectiveness of all drugs sold in interstate commerce, and, if an approved drug is not shown to be safe or effective, the Agency must begin withdrawal proceedings. The Agency has forsaken these obligations in the name of a proposed voluntary program, Guidance # 209, and acted contrary to the statutory language.
. . .
[FDA] must evaluate the safety risks of the petitioned drugs and either make the finding that the drugs are not shown to be safe or provide a reasoned explanation as to why the Agency is refusing to make such a finding.”
The Citizen Petitions asked FDA to act on medically important antibiotics that are being fed to healthy livestock and are contributing to the looming public health crisis of antibiotic resistance. Antibiotic resistance can lead to longer illnesses, the use of antibiotics with greater side effects, and even death when treatments fail. Almost seventy percent of all antibiotics sold in the US are used on healthy livestock, to promote faster weight gain and compensate for unsanitary, crowded conditions. Yet, in the face of the rising public health threat of antibiotic resistance, the FDA has largely failed to act. This is in spite of the fact that, as the Court notes, “the Agency has all but made a finding that the subtherapeutic use of antibiotics in food-producing animals has not been shown to be safe.”