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.
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 sole non-cooperative company can still lawfully sell the drugs that had been approved by FDA for that purpose. And no law in force forbids farmers from buying the drugs from the company.
Secondly, as the FDA guidance of judicious use of antibiotics drugs is purely voluntary, there is no guarantee that the affected drug companies will not reinstate the label for growth use. There has yet been any penalty for violating this sort of “gentleman’s agreement.”
The choice of the voluntary policy by FDA to some extent was understandable. According to its “Guidance for Industry (GFI) #209” released in April 2012, FDA admitted that there are substantial legal hurdles facing the agency if it opts for 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 ultimate 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 the current regulatory framework that cannot effectively and legitimately deal with the challenges posed by antimicrobial resistance that obviously constitutes serious public health crises. The lack of an appropriate authority given to FDA to tackle such emergencies indicates an urgent need for Congress to do the right thing.