“This drug is indicated for use in a limited and specific population of
patients.”166 The ADAPT Act, which was never passed into law, also sought
to strengthen resistance monitoring by the CDC by ensuring that up-to-date
and cutting-edge data was available to the government, as well as to
Most recently, in December 2014, Senators Orrin Hatch (R-UT)
and Michael Bennet (D-CO) re-introduced legislation to accelerate the
approval of new antibiotics.168 The Promise for Antibiotics and
Therapeutics for Health (PATH) Act sought to establish a new drug
approval pathway in order to encourage development and streamline the
process of antibiotic drugs in the FDA for an “identifiable, limited patient
population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need.”169 In addition, the
PATH Act requires a special designation on antibiotic drug labels to
indicate their intended use in limited, high-risk populations.170 The
legislation takes a creative approach by emphasizing the importance of such
research, particularly veterans who have encountered antibiotic-resistant
bacteria while overseas.171 The legislation received support from IDSA,
which emphasized that, “the PATH Act will not only help spur the
development of urgently needed new antibiotics . . . [it] will also help
ensure these precious new drugs are used appropriately to limit the
development of resistance.”172
As of November 2016, Congress has yet to act upon the PATH
Act.173 It is too soon to tell, but Congress’ track record indicates general
apathy on the issue.174 This apathy, coupled with lobbying challenges by
both the pharmaceutical and agriculture industries, makes the bill’s passage
into law seem unlikely. However, with the Obama Administration’s recent
push for antibiotic resistance efforts, the time is ripe for change.175 Passing
166. Outterson, supra note 64, at 280.
167. H.R. 3742 § 2.
168. Promise for Antibiotics and Therapeutics for Health Act, S. 2996, 113th Cong.
169. Bennet, Hatch Reintroduce PATH Act to Streamline Approval of Antibiotics, SEN.
MICHAEL BENNET (Jan. 16, 2015), https://www.bennet.senate.gov/?p=release&id=3229.
173. See Promise for Antibiotics and Therapeutics for Health Act, S. 185, 114th Cong.
174. Fox, supra note 29, at 48, 51.
175. See Press Release, Office of the Press Sec’y, The White House, FACT SHEET:
Obama Administration Releases National Action Plan to Combat Antibiotic-Resistant
Bacteria (Mar. 27, 2015), https://www.whitehouse.gov/the-press-office/2015/03/27/fact-
sheet-obama-administration-releases-national-action-plan-combat-ant (releasing a plan for
federal departments and agencies to combat the rise of antibiotic-resistant bacteria); see