used REMS to restrict the distribution of over twenty narcotics, most closely
associated to drug-related deaths in the United States.120 Further, the FDA
may impose civil monetary penalties for violations of the REMS provisions,
in addition to the deeming the drug misbranded.121
While the FDA has yet to use REMS restrictions for any antibiotic
products, it is certainly within their purview to do so.122 A novel antibiotic,
whose efficacy and longevity depends on its limited use, warrants a REMS
restriction to protect the public health.123 In the context of antibiotics, REMS
restrictions would aim to limit the prescription of a certain antibiotic drug to
instances where they are absolutely clinically necessary.124 For example, the
FDA could require that patients undergo testing to confirm the type of
bacterial infection before being prescribed a REMS-restricted antibiotic or
place limits on physicians’ prescribing abilities.125 Imposing a REMS
restriction could therefore effectively reduce the rate of antibiotic resistance
and prolong the effective lifespan of the drug.126
Some fear that REMS restrictions to conserve antibiotics in the clinical
context may threaten physician autonomy by interfering with the practice of
medicine.127 Congress intended the Federal Food, Drug, and Cosmetic Act
(“FD& C Act”) to regulate the safety of drugs, but did not allow for it to
inhibit a physician’s ability to prescribe drugs, once they have been
approved.128 REMS restrictions run the risk of a having a chilling effect on
antibiotic prescriptions to patients who actually need them, thereby adversely
affecting patient outcomes.129 However, in clinical practice, a REMS
restriction is not likely to limit patient access. Rather, the system merely adds
a system of checks on the prescribing physician to affirm that the drug is
ionbyDrugClass/ ucm163647.htm (last visited Nov. 14, 2016) (providing an example of REMS
restriction usage in 2012).
120. Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy
(REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics, U.S. FOOD &
DRUG ADMIN., http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.
htm (last updated Mar. 1, 2013).
121. Evans, supra note 109, at 521–22.
122. See Fox, supra note 29, at 59 (describing the ways in which the FDA could use
REMS restrictions if they chose).
123. Id. (explaining that through a REMS restriction, “the FDA could require that
physicians prescribing these medications meet the requirements of safe use as defined under
124. Id. at 59.
125. Id. (explaining that antibiotics should only be used for bacterial infections and not
126. See Fox, supra note 29, at 59–60.
127. See id. at 60.
128. See JAMES ROBERT NIELSEN, HANDBOOK OF FEDERAL DRUG LAW38 (George
Mundorff & Susan Hunsberger eds., 2d ed. 1992).
129. Fox, supra note 29, at 60.