I. ANTIBIOTIC RESISTANCE
Antibiotics are drugs used to treat infections caused by bacteria. 6 With the
increased use of antibiotics in the practice of medicine came a sharp decline
in morbidity and mortality once associated with acute bacterial infections. 7
Antibiotics allow us to quickly and accurately treat bacterial infections,
infectious diseases, foodborne illnesses, bacterial pneumonias, and other
conditions in a way that would seem miraculous a century ago to those who
practiced medicine. 8 Antibiotic use also expanded the practice of medicine to
allow for a broader range of treatments. 9 For instance, without antibiotics,
patients undergoing chemotherapy for cancer, or dialysis for renal failure,
would be highly susceptible to infectious complications, which may render
their treatments fatal. 10 It is difficult to imagine modern surgical procedures,
such as organ transplants, without using antibiotics to prevent potentially
fatal surgery-related infections. 11
Despite their medical successes, 12 antibiotics are losing their effectiveness
at an alarming rate. 13 Since bacteria are highly adaptive microorganisms, 14 no
matter how carefully they are used, antibiotics intrinsically create
evolutionary pressure for resistance. 15 This phenomenon has been
6. See Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture: Hearing
Before the Subcomm. on Health of the Comm. on Energy & Commerce, 111th Cong. 33 (2010)
(statement of Joshua M. Sharfstein, Principal Deputy Comm’r, Food & Drug Admin.).
7. See CTRS. FOR DISEASE CONTROL & PREVEN TION, Achievements in Public Health, 1900-
1999: Control of Infectious Diseases, 48 MORBIDITY & MORTALITY WKLY. REP. 621, 621–22
(1999) (showing that after the first use of penicillin, the introduction of the Salk Vaccine, and
the Passage of the Vaccination Assistance Act, mortality was at its lowest in the late 20th
8. See WHITE HOUSE, NATIONAL STRATEGY FOR COMBATING ANTIBIOTIC-RESISTANT
BACTERIA 1 (2014), https://www.whitehouse.gov/sites/default/files/docs/carb_national_strate
gy.pdf [hereinafter NATIONAL STRATEGY].
9. See Cesar A. Arias & Barbara E. Murray, Antibiotic-Resistant Bugs in the 21st
Century— A Clinical Super-Challenge, 360 NEW ENG. J. MED. 439, 439-40 (2009) (pointing
to the critical role of antibiotics in the treatments for cancer, HIV, and MRSA and the
developments in surgery and transplantations).
10. AN TIBIOTIC RESISTANCE THREATS, supra note 2, at 5.
11. Arias & Murray, supra note 9, at 439.
12. See Fernando Bacquero & Jesús Blázquez, Evolution of Antibiotic Resistance, 12
TRENDS ECOLOGY & EVOLUTION 482, 482 (1997) (noting that antibiotics represent the
“protective umbrella” under which advancements in modern medicine, such as intensive care,
advanced surgery, chemotherapy, and organ transplantation, have been developed).
13. BAD BUGS, supra note 1, at 9.
14. See Vanessa K.S. Briceño, Superbug Me: The FDA’s Role in the Fight Against
Antibiotic Resistance, 9 N. Y.U. J. LEGIS. & PUB. POL’Y 521, 522 (2005).
15. See D. J. Austin et al., The Relationship Between the Volume of Antimicrobial
Consumption in Human Communities and the Frequency of Resistance, 96 PROC. NAT’L
ACAD. SCI. 1152, 1152 (1999).