declined in recent decades. 61 Thus, we are left without a pipeline of novel
antibiotics to replace those gradually lost to antibiotic resistance. 62 Large
pharmaceutical companies, once trailblazers in the field of antibiotic R& D,
have since shifted their focus to more profitable research activities. 63 For
instance, United States antibiotic sales peaked in 2005 and have subsequently
declined compared to other prescription drugs. 64 Relatedly, the total number
of new antibacterial agents approved by the FDA has declined consistently
over the last twenty-five years. 65 For example, the FDA approved sixteen new
systemic antibacterial agents in 1983-1987, 66 yet approved only two new
systemic antibacterial agents from 2008-2012.67
R& D is often associated with time-consuming and expensive regulatory
challenges associated with conducting the clinical trials needed for new drug
approval, and research in antibiotic drug development is no exception. 68 One
of the most significant reasons for the failure in antibiotic drug development
is the low economic return that makes the development of novel antibiotics
an unattractive investment. 69 Since the pharmaceutical industry operates on a
price/volume model, it demands that R& D funds be allocated where return
on investment (ROI) is greatest, thus incentivizing investment in products
that will sell at the greatest volume or at the highest price. 70
Unfortunately, the ROI for antibiotics is low. 71 First, lost-cost generic
61. The decline in R& D investment began over ten years ago. In 1990, half of the large
pharmaceutical companies in the United States and Japan either halted or decreased their
antibiotic discovery efforts. This trend continued in 2000 when spun off its anti-infective
discovery division. Furthermore, Bristol-Myers Squibb Company Abbott Laboratories, Eli
Lilly and Company, and Wyeth all halted or substantially reduced their anti-infective
discovery efforts in 2002. More companies continue to indicate a decline in their R& D efforts.
BAD BUGS, supra note 1, at 14.
62. Brad Spellberg et al., The Epidemic of Antibiotic-Resistant Infections: A Call to Action
for the Medical Community from the Infectious Diseases Society of America, 46 OXFORD J.
CLINICAL INFECTIOUS DISEASES 155, 155 (2008), www.idsociety.org/workarea/download
63. See BAD BUGS, supra note 1, at 3.
64. Kevin Outterson et al., Repairing the Broken Market for Antibiotic Innovation, 34
HEALTH AFF. 277, 278–79 (2015), http://content.healthaffairs.org/content/34/2/277.abstract.
65. Spellberg et al., supra note 62, at 158.
66. BAD BUGS, supra note 1, at 15.
67. Mari Sevebrov, U.S. Goes On The Offensive To Keep Superbugs In Check,
(last visited Nov. 14, 2016).
68. See Cindy R. Friedman & Cynthia G. Whitney, It’s Time for a Change in Practice:
Reducing Antibiotic Use can Alter Antibiotic Resistance, 197 J. INFECTIOUS DISEASES 1082,
69. Outterson et al., supra note 64, at 279.
70. See id. at 278.
71. Id. at 279.