physical dependence or psychological dependence relative to the drugs in
Schedule IV.202 Other Schedule V drugs include antidiarrheal, antitussive,
and analgesic medications.203 Antibiotic drugs could fall under the purview
of the CSA if the HHS Secretary established scientific findings to
demonstrate that misuse or abuse of antibiotics constitutes a threat to public
health, thereby justifying federal control of the drug and satisfying the first
element of a Schedule V drug under the CSA.204 This would be an
innovative use of the CSA because the purported abuse not only harms the
individual, but the greater concern is one of public health. As noted above,
the CDC reports that up to fifty percent of all antibiotics prescribed are
unnecessary, giving rise to the looming public health threat of antibiotic
To avoid penalties or liability through the over-prescription of
antibiotics, doctors need only do what they are already supposed to do:
prescribe antibiotics when it is medically necessary to do so.206 However,
critics of controlled substance laws suggest that they deter doctors from
providing appropriate medication.207 Such efforts may threaten physician
autonomy by interfering with the practice of medicine and run the risk of a
chilling effect on the appropriate prescription of antibiotics to patients who
actually need them, thereby adversely affecting patient outcomes.208 Still, in
clinical practice, scheduling a drug does not necessarily lead to limiting
access to patients who need them.209 Rather, the system merely adds a
system of checks on the prescribing physician to affirm that the drug is
clinically necessary before prescribing it.210 Further, the CSA does not
address the issue of antibiotic innovation; it is just one potential piece in a
202. 21 U.S. C. § 812(b)( 5) (2012).
203. U.S. DRUG ENFORCEMENT ADMIN., Drug Scheduling, http://www.dea.gov/druginfo/
ds.shtml (last visited Nov. 14, 2016).
204. See 21 U.S. C. § 811(c)( 6) (2015) (noting that the danger of the drug to the public
health is a factor that should be taken into account when making scheduling decisions).
205. See CTR. FOR DISEASE CONTROL & PREVENTION, Antibiotic Resistance Questions &
Answers, http://www.cdc.gov/getsmart/community/about/antibiotic-resistance-faqs.html (last
updated Apr. 17, 2015) (noting that the unnecessary overuse drives resistance).
206. Markow, supra note 197, at 542 (discussing how the law places no limits on when a
particular legend drug may be prescribed).
207. See The Supreme Court — Leading Cases: Gonzales v. Oregon, 120 HARV. L. REV.
361, 365 (2006) (discussing how the CSA was not intended to regulate medical practice and
was meant to prevent drug abuse).
208. See Fox, supra note 29, at 59–60; see also Evans, supra note 109, at 514 (limiting
physician prescription practices may inhibit physicians from prescribing antibiotics to patients
who could benefit from the antibiotics).
209. See Fox, supra note 29, at 59 (discussing a REMS restriction on antibiotics that are
in need of preservation).
210. See id.