clinically necessary before prescribing it.130 Further, critics may argue that
the REMS render drug lifecycle management more costly and complex.131
Still, this is a small burden to bear compared to the large public health threat
of antibiotic resistance.
Lastly, while a REMS restriction may adequately address the issue of
antibiotic conservation, it is just one piece of the puzzle.132 The issue of
antibiotic innovation remains unresolved by this solution, necessitating
further action by Congress. Having described the executive branch’s actual
and potential efforts to combat antibiotic resistance, Part III turns to
Congress’ role in combating the growth of antibiotic-resistant bacterial
III. CONGRESS’ ROLE IN COMBATTING ANTIBIOTIC-RESISTANT BACTERIAL
The growth of antibiotic-resistant bacteria may be slowed through
congressional action.133 For the past 30 years, Congress has struggled to
establish legislative strategies to reduce the overuse, curb misuse, and
incentivize the development of novel antibiotic drugs.134 For example, as
described in Figure 1 below, several bills have been introduced in Congress
130. See id. at 60 (explaining that REMS restrictions would curtail inappropriate antibiotic
131. Evans, supra note 109, at 515.
132. See Fox, supra note 29, at 60 (describing that REMS is one part of the larger global
problem associated with inappropriate antibiotic use).
133. Orrico, supra note 54, at 283–84.
134. Id. at 277.
Figure 1. Proposed Antibiotic-Related Legislation Timeline