Concluding Remarks

This chapter has explained that the overall policy of the FDA in addressing antibiotic resistance reflects the idea of precaution. Although the precautionary principle or approach has yet to be explicitly written into statute, the precau­tion remains influential over competent agencies in responding to health risks, which is particularly revealed in the shifting of the burden of proof on safety.

The chapter also found that the FDA’s voluntary approach is to some extent a result of evading the burdensome CBA.

On the other hand, it appears that the FDA’s approach has won the legal battle at the current stage, given the court’s inclination to defer to the FDA’s discretion not to continue the original withdrawal procedure. While the vol­untary policy has successfully reduced the use of antibiotics for growth promo­tion, critical questions remain unresolved.

First, in interpreting the FDCA, the appellate court held that the finding of safety will not occur until the conclusion of a hearing process. Yet the restric­tive view may cast the original scientific finding that triggers the hearing pro­cess in a vague and embarrassing position. Consequently, there would be no room for such a “finding” in the FDCA per se.

Second, applying a voluntary policy may save legal costs and avoid lengthy proceedings. It is also a reflection of the FDA’s tendency to avoid the possible hurdles raised by the implementation of CBA. The bypass of the withdrawal procedure embodied in the FDCA reveals the insufficiency of legal tools. Apart from withdrawing the NADA, there are no other laws in effect controlling the use of antibiotics in the growth promotion of animals. If the policy eventually proves below expectations, it will slow the process of phasing out such use and worsen the health crisis.

Many drafts regulating antibiotics for growth purposes on a comprehensive scale have been introduced in the U.S. Congress.^[85] However, none of them have been adopted. An optimal solution depends on the empowerment of the FDA with adequate legal authorities and tools to control antibiotic resistance.

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