By Kuei-Jung Ni
Faced with increasing concerns about the misuse and overuse of antibiotics for food animals’ growth enhancement, which has caused serious antimicrobial resistance, FDA finally took action in December 2013 by issuing guidelines that ask antibiotics makers to remove the labeling of antibiotics for growth effects on a “voluntary” basis. FDA officials believe that voluntary participation “is the fastest, most efficient way to make these changes.”
As the restriction of antibiotics only applies to growth promotion and disease preventive uses are still permitted, critics argued that the new policy will create a loophole and no guarantee for the decrease of antibiotics’ usage by farmers. Further, without giving FDA any authority to require drug companies to release sales data of antibiotics, some said it remains illusory to monitor and verify the actual usage of the drugs.
According to the FDA’s strategy plan, pharmaceutical companies may respond with their intention of voluntary compliance within three months after the notice. In March 2014, FDA announced that 25 of the 26 drug makers affected have agreed to follow the voluntary withdrawal. In effect, these food animal producers can only use the companies’ drugs sold in the market for therapy purposes. Indeed, the predominant support by industry signals an encouraging and good starting point for implementing the FDA policy. Nevertheless, it leaves some legal questions unsolved, which may trigger further disputes in the future.