manufacturers by providing federal funding for grants and contracts to
perform clinical trials for orphan products, offering a research tax credit of
fifty percent of clinical testing costs, and guaranteeing a seven year market
exclusivity period from the date of marketing approval.182 From 1983 to
2010, over 350 therapies entered the United States market with orphan
designations.183 While the ODA has been most effective in oncology drugs,
it has been used for products that target infectious diseases as well.184
The ODA helps address the issue that arises from the price/volume
model of the pharmaceutical industry, which would otherwise avert
pharmaceutical companies from investing in R& D for rare diseases.185 The
ODA has already incentivized pharmaceutical manufacturers to pursue
antibiotic R& D by decreasing the upfront R& D costs.186 Indeed, the
FDAAA of 2007 financially supported a conference to determine when
ODA incentives for certain antibiotics developed to treat infectious diseases
due to antibiotic-resistant bacteria.187 There has since been an increase in
antibiotic therapies with Orphan Drug designation without any significant
change to the law.188 While the ODA incentivizes innovation, it does not
address the issue of antibiotic conservation.189 Thus, the ODA should be
looked at as just one piece of the puzzle, rather than a cure-all to solve
B. The Controlled Substances Act
The CSA is the federal government’s primary means of controlling
the supply of drugs.191 The statute allows the federal government to control
access and use of certain drugs, and it can even eliminate classes of drugs
182. Id. at 140.
184. Id. at 141.
185. See Henry A. Waxman, The History and Development of the Orphan Drug Act, in
ORPHAN DISEASES & ORPHAN DRUGS 135, 139–40 (1986).
186. Enrique Seoane-Vazquez et al., Incentives for Orphan Drug Research and
Development in the United States, 3 ORPHANET J. OF RARE DISEASES 1, 5 (Dec. 16, 2008),
187. Food and Drug Admin. Amendments Act of 2007, Pub. L. No. 110-85 § 1112, 121
Stat. 976 (2007).
188. Kesselheim & Outterson, supra note 83, at 140–141 (“In the first half of 2008, two
of the sixty-one new orphan drug designations related to antibiotics. For example, one of the
orphan drug designations was granted to Mpex Pharmaceuticals for an IDSA-designated
priority pathogen, specifically for the ‘[t]reatment of pulmonary infections due to
Pseudomonas aeruginosa and other bacteria in cystic fibrosis patients.’”).
189. Id. at 142.
190. See id.
191. Thomas M. Quinn & Gerald T. McLaughlin, The Evolution of Federal Drug Control
Legislation, 22 CATH. U. L. REV. 586, 605 (1973) (explaining that the enactment of the CSA
repealed all prior federal drug legislation and created a comprehensive scheme for drug control
in one statute).