infections, strengthen surveillance, accelerate R& D for new antibiotics, and
improve international collaboration.98
While these calls to action are certainly welcomed, these measures remain
little more than “feel good” actions without statutory and regulatory teeth.
Taking President Obama’s lead, the FDA and Congress should implement
statutory reform to halt antibiotic resistance as a mounting public health
concern, while simultaneously preserving incentives to continue developing
A. The Role of the FDA
The FDA recognized antibiotic resistance as a health concern as far back
as 1977, but has yet to effectively limit the use of antibiotics for human
disease prevention and growth promotion in food animals.99 Despite its
criticisms for inaction, the FDA has taken some steps towards regulating
antibiotics to prevent overuse and abuse in livestock.100 The FDA issued two
Guidances for Industry (GFI #209 and #213) that request voluntarily phasing
out antibiotics in livestock for production purposes and advise that licensed
veterinarians should oversee uses of antibiotic drugs in livestock.101 These
GFIs also advise that animal drug companies should change their labels on
drugs to withdraw any claims that such drugs can be used for growth
The FDA has also taken steps towards regulating antibiotics to prevent
overuse and abuse in humans through labeling requirements.103 As of 2003,
the FDA requires that antibiotic labels display information about the risks of
antibiotic resistance by reminding physicians that the drug should be used
only to treat infections proven or highly suspected to be bacterial in order to
98. NATIONAL STRATEGY, supra note 8, at 1–2.
99. Nat. Res. Def. Council, Inc. v. U.S. FDA, 884 F. Supp. 2d 127, 134–36 (S. D.N.Y.
100. See U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY #209, THE JUDICIOUS USE
OF MEDICALLY IMPORTANT ANTIMICROBIAL DRUGS IN FOOD-PRODUCING ANIMALS 9 (2012),
guidanceforindustry/ ucm216936.pdf [hereinafter GUIDANCE FOR INDUSTRY #209]; see also
U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY #213, NEW ANIMAL DRUGS AND NEW
ANIMAL DRUG COMBINATION PRODUCTS ADMINISTERED IN OR ON MEDICATED FEED OR
DRINKING WATER OF FOOD-PRODUCING ANIMALS: RECOMMENDATIONS FOR DRUG SPONSORS
FOR VOLUNTARILY ALIGNING PRODUCT USE CONDITIONS WITH GFI #209 8 (2013),
ceforIndustry/UCM299624.pdf [hereinafter GUIDANCE FOR INDUSTRY #213].
101. GUIDANCE FOR INDUSTRY #209, supra note 100, at 9; GUIDANCE FOR INDUSTRY #213,
supra note 100, at 8.
102. GUIDANCE FOR INDUSTRY #209, supra note 100, at 9; GUIDANCE FOR INDUSTRY #213,
supra note 100, at 8.
103. Saver, supra note 30, at 466.