A Critical Review on FDA Voluntary Policy
According to the FDA’s strategic plan, pharmaceutical companies may respond to their intention of voluntary compliance within three months after the
Phasing Out Antibiotics in Food Animals 25 notice.
As previously mentioned, most drug companies deferred to the policy. In effect, food animal producers can only use pharmaceutical companies’ drugs sold in the market for therapeutic purposes. Indeed, the predominant support by the industry signals an encouraging and strong starting point for implementing the FDA policy. However, it leaves some legal questions unresolved, which may trigger additional disputes in the future.First, the legality of using antibiotics to promote animal growth in the real world remains a dubious proposition. Because no law prohibits such a use per se, uncooperative companies can still legally sell the drugs approved by the FDA for that purpose. No law in force forbids farmers from buying such drugs from companies.
Second, as the FDA guidance for the judicious use of antibiotic drugs is on a voluntary basis, there is no guarantee that the affected drug companies cannot reinstate the label for growth use. There has not yet been any consequential punishment or coercive measures exercised for violations of such a “gentlemen’s agreement.”
The FDA’s choice of a voluntary policy to some extent was understandable. According to its “Guidance for Industry (GFI) #209,”[82] released in April 2012, the FDA admitted the legal hurdles facing the agency if it opts to initiate an official withdrawal action of NADA. The FDA needs to initially bear the burden in providing evidence about the safety concerns.[83] Yet the affected companies can rebut the finding.[84] The withdrawal process can be lengthy, and the ultimate ruling appears unpredictable and may not necessarily be in favor of the FDA position.
Unless it is engaged in the withdrawal of the NADA process, the FDA has no other legal power or tools by which drug companies are forced to phase out the sale of antibiotics for growth-promotion purposes. This legal impediment reveals the insufficiency of the current regulatory framework, which cannot effectively and legitimately address the challenges posed by antimicrobial resistance that obviously constitutes serious public health crises. The lack of an appropriate authority accorded the FDA to tackle such emergencies demonstrates an urgent need for Congress to do the right thing.
VII.
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