In a decision earlier today, a federal court in New York ruled that the Food and Drug Administration (FDA) cannot delay regulatory proceedings for penicillin and tetracyclines use in livestock – two kinds of antibiotics whose overuse in animals is reducing their effectiveness in treating sick people. This is good news!
The court action 1) ensures that action is not delayed further until after the resolution of an appeal by FDA of the court’s original decision to mandate these proceedings and 2) imposes a deadline for the completion of the proceedings (thereby rejecting FDA’s arguments that a schedule was not needed). FDA will have approximately five years to complete proceedings.
A quick refresher on how we got here: In 1977, FDA found that the use of penicillin and tetracyclines in animal feed poses risks for human health because it leads to the development of antibiotic-resistant bacteria. Antibiotic resistance reduces the efficacy of important medicines and can lead to longer illnesses, more hospitalizations, the use of drugs with greater side-effects, and even death when treatments fail. As the Director General of the World Health Organization has warned, bacteria are becoming so resistant to common antibiotics that it could mean “the end of modern medicine as we know it,” and “[t]hings as common as strep throat or a child’s scratched knee could once again kill.”
We sued FDA to force FDA to address this threat, and back in March, the court ruled that FDA must withdraw approvals for the use of penicillin and tetracyclines in animal feed unless drug manufacturers prove in regulatory hearings that such uses are safe for human health.
In imposing a schedule for FDA action today, the court pointed to FDA’s “unreasonable” 35-year delay in “perform[ing] its statutorily-prescribed duty to initiate, let alone complete, withdrawal proceedings” for penicillin and tetracyclines. In other words, it’s been long enough already.
FDA needs to move forward as rapidly as possible with the regulatory proceedings to address this pressing health threat and to rectify its decades-long neglect of this issue.
It’s time to quit stalling and get going.