combat antibiotic resistance.104 The drug label must also advise physicians to
use appropriate screening tests to prescribe the proper antibiotic.105 Lastly,
the label must remind physicians to counsel their patients to follow their
course of treatment from start to finish to avoid resistance problems.106
However, these labeling requirements are often ignored by prescribing
physicians and have had little influence on prescribing practices.107
B. REMS for Antibiotics
The FDA has the capacity to regulate the use of antibiotics in humans and
animals through its authority to establish REMS restrictions.108 REMS was
created as a part of the Food and Drug Administration Amendments Act of
2007 (FDAAA).109 REMS restrictions allow the FDA to limit the use of a
particular drug to instances where its benefits are likely to outweigh its risks
by mandating additional post-market requirements.110 The FDA may use
REMS restrictions to limit access to new or existing drugs, block the approval
of new drugs, or withdraw the approval of existing drugs.111 The FDA can
impose a REMS restriction in many forms, hinging on elements to assure safe
use, including: ( 1) allowing a restricted drug to be prescribed only by certain
practitioners with special qualifications;112 ( 2) requiring certification for
entities that dispense a restricted drug;113 ( 3) requiring that drugs be
administered only in specific healthcare settings, rather than at home;114 ( 4)
requiring that patients comply with certain conditions of use;115 ( 5) requiring
patients to be monitored to detect adverse events;116 and ( 6) requiring patients
taking a restricted drug to enroll in a registry to surveil outcomes.117 The FDA
can impose a REMS restriction at any time in a drug’s lifecycle.118 REMS
restrictions have also been effective in practice, as in 2012,119 when the FDA
104. 21 C.F.R. § 201.24 (2008).
105. Saver, supra note 30, at 466.
107. Id. at 468.
108. Barbara J. Evans, Seven Pillars of a New Evidentiary Paradigm: The Food, Drug,
and Cosmetic Act Enters the Genomic Era, 85 NOTRE DAME L. REV. 419, 511–12 (2010).
110. 21 U.S. C. § 355-1(a)( 2)( A) (2008).
111. Fox, supra note 29, at 58.
112. 21 U.S. C. § 355-1(f)( 3)( A).
113. 21 U.S. C. § 355-1(f)( 3)( B).
114. 21 U.S. C. § 355-1(f)( 3)( C).
115. 21 U.S. C. § 355-1(f)( 3)( D).
116. 21 U.S. C. § 355-1(f)( 3)(E).
117. 21 U.S. C. § 355-1(f)( 3)(F).
118. Evans, supra note 109, at 512.
119. See Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and
Long-Acting Opioids, U.S. FOOD & DRUG ADMIN., www.fda.gov/Drugs/DrugSafety/Informat