antibiotics in livestock by amending the FD& C Act to require animal drug
manufacturers to demonstrate that “no harm to human health will be caused
due to the development of antimicrobial resistance attributable to certain
uses of that particular drug.”155 Representative Slaughter re-introduced
PAMTA156 in 2013 and 2015 which, again, was proven futile.157
In 2011, Representative Phil Gingrey, M. D. (R-GA) introduced the
Generating Antibiotics Incentives Now (GAIN) Act.158 The GAIN Act
sought to reform the patent system by granting an additional five years of
market exclusivity for “qualified infectious disease products.”159 At last, the
GAIN Act’s provisions were successful and signed into law in July 2012 by
President Obama as part of the Food and Drug Administration Safety and
Innovation Act.160 Only four antibiotics have become available the in U.S.
market with this designation as of December 29, 2014.161 However, critics
such as Kevin Outterson caution that efficacy of this law should not be
overstated, warning that “qualifying infectious disease product designations
should not be interpreted as evidence of accelerated antibiotic
In December 2013, Phil Gingrey (R-GA) and Gene Green (
D-TX) introduced the Antibiotic Development to Advance Patient Treatment
(ADAPT) Act.163 The ADAPT Act made it quicker and less expensive for a
pharmaceutical company to place an antibiotic drug on the market164 by
amending the FD& C Act to create a pathway for the prompt approval of
antibacterial drugs intended to treat serious or life-threatening diseases and
conditions.165 The ADAPT Act also requires additional labeling, stating:
155. AM.VETERINARYMED.ASSOC.,PRESERVATION OFANTIBIOTICS FORMEDICAL
TREATMEN T ACT (PAMTA) — H.R. 1552 (2016), https://www.avma.org/Advocacy/National/
Congress/Documents/IB_PAMTA_2016.pdf; Preservation of Antibiotics for Medical
Treatment Act of 2015, H.R. 1552, 114th Cong. § 4 (2015).
156. Preservation of Antibiotics for Medical Treatment Act of 2013, H.R. 1150, 113th
157. GOVTRACK, H.R. 1150 (113th): Preservation of Antibiotics for Medical Treatment
Act of 2013, https://www.govtrack.us/congress/bills/113/hr1150 (last visited Jan. 27, 2017).
158. Generating Antibiotic Incentives Now Act of 2011, H.R. 2182, 112th Cong. (2011).
159. GAIN: How a New Law Is Stimulating the Development of Antibiotics, PEW
CHARITABLE TRUSTS (Nov. 7, 2013), http://www.pewtrusts.org/en/research-and-analysis/
161. Outterson, supra note 64, at 281.
163. Antibiotic Development to Advance Patient Treatment Act of 2013, H.R. 3742,
113th Cong. (2013).
164. ‘ADAPT’: A Regulatory Pathway to Develop Antibiotics and Fight Drug Resistant
Infections, PEW CHARITABLE TRUSTS (Jan. 29, 2014), http://www.pewtrusts.org/en/research-
165. Access to Marketplace Insurance Act, H.R. 3742, 114th Cong. (2015).