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 actions on December, 2013 by issuing guidelines that ask drug makers to remove the labeling of antibiotics for growth effects on a “voluntary” basis. FDA officials believe the voluntary participation “is the fastest, most efficient way to make these change.”
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 an 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 their intention of voluntary compliance within three months after the notice. On March, 2014, FDA announced that 25 of the 26 drug makers affected have agreed to follow the voluntary withdrawal. In effect, food animal producers can only use the companies’ drugs sold in the market for therapy purpose. 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.
Firstly, it remains dubious about the legality of using antibiotics to promote animal growth in the real world. As no law prohibits such a use per se, the only non-cooperative company can still lawfully sell the drugs that had been approved by FDA for that purpose. No any law in force forbids farmers from buying the drugs from the company.
Secondly, as the FDA guidance of judicious use of antibiotics drugs is of voluntary basis, there is no guarantee that the affected drug companies cannot reinstate the label for growth use. There has yet been any penalty for violating the “gentlemen agreement.”
The choice of the voluntary policy by FDA to some extent was understandable. According to its “Guidance for Industry (GFI) #209” released on April, 2012, FDA admitted the legal hurdles facing the organ if it opts to initial an official withdrawal action of new animal drug application (NADA). The law will require FDA to bear a burden to provide evidence about the safety concerns of the use. Yet, the affected companies are allowed to rebut the finding. The withdrawal process can be lengthy, and the ultimately ruling appears unpredictable and may not necessarily favor the position of FDA.
Unless engaging in the withdrawal of NADA process, FDA has no other legal power or tool by which drug companies are forced to phase out the sale of antibiotics for growth promoting purpose whose effects had been approved by FDA previously.
The legal impediment reveals the insufficiency of current regulatory framework that cannot effectively and legitimately deal with the challenges posed by antimicrobial resistance that obviously constitutes serious public health crises. The lacking of an appropriate authority given to FDA to tackle such emergencies indicates an urgent need for Congress to do a right thing.