the PATH Act would be a positive step to incentivize the development of
antibiotics through reducing the burden of the clinical trial process, as well
as to encourage conservation through labeling changes.176 Congress would
be wise to act expediently to pass the PATH Act as a first step to addressing
both conservation and innovation in the field of antibiotics. Understanding
Congress’ limitations to granting legislation to curb antibiotic-resistance,
Part IV proposes working creatively within the existing statutory
framework to address both pharmaceutical innovation and antibiotic
conservation in the field of antibiotics through the Orphan Drug Act (ODA)
IV. USING EXISTING LEGISLATION TO PROMOTE
As demonstrated above, Congress has tried and failed again to
implement regulations to effectively conserve antibiotic drugs and
incentivize the development of new classes of antibiotic therapies. An
alternative to implementing new law is to work creatively within the
existing statutory framework to address both conservation and innovation in
the field of antibiotics. Regarding innovation, the ODA may be used to
encourage pharmaceutical manufacturers to invest in R& D in the field of
antibiotics.177 When it comes to conservation, the CSA may be creatively
interpreted to monitor the distribution of antibiotics.178
A. The Orphan Drug Act
The ODA was passed in 1983 to encourage research for the
treatment of rare conditions affecting less than 200,000 people in the United
States.179 Companies may also apply for an orphan designation without
hitting this benchmark if they can establish that developing a drug for the
condition is otherwise economically disadvantageous because there is “no
reasonable expectation” that sales could support development of the drug in
the United States.180 The ODA is a form of “federal cost-sharing” for
qualified research projects that also aims to lessen the cost and regulatory
burden of the clinical trial process.181 The ODA encourages pharmaceutical
generally NATIONAL STRATEGY, supra note 8 (outlining the goals of the United States
Government to reduce antibiotic resistant bacteria and protect the public from related threats).
176. See S. 2996.
177. See Kesselheim & Outterson, supra note 83, at 139 (explaining that the ODA can
decrease up-front costs of R& D through tax incentives and research grants).
178. See Geltman, supra note 135, at 123 (conjecturing that scheduling under the CSA
might be qualified because there is evidence that some antibiotic misuse is psychological).
179. 21 U.S. C. § 360ee(b)( 2) (2006).
181. Kesselheim & Outterson, supra note 83, at 139.