over $6 billion to fund medical research, but has drawn extensive criticism
over provisions that codify long-standing demands of the pharmaceutical
industry.158 Extensive portions of the Act affect the FDA,159 including the
process(es) through which the Agency reviews drug applications.160
As noted above, the Act also has a direct impact on the priority review
voucher program, namely by creating a new stream for medical
countermeasures.161 Moreover, the new legislation also makes some strides
in incorporating mandatory assessment mechanisms for all types of vouchers
(and not just for pediatric vouchers, as until now), as well as reinforcing the
idea that the vouchers are supposed to enhance innovation for neglected or
rare diseases. Section 3014 of the 21st Century Cures Act mandates that GAO
conduct a study of the multiple priority review voucher programs.162 The
resulting reports must be submitted to the Committee on Health, Education,
Labor, and Pensions of the Senate and to the Committee on Energy and
Commerce of the House by January 31, 2020.163 Section 3014(c) provides an
exhaustive list of issues to be addressed by GAO. Among these, it is worth
highlighting the provision that mandates a determination of “whether, and to
what extent, the voucher impacted the sponsor’s decision to develop the
drug.”164 For drugs approved under the neglected tropical disease program,
the proposed legislation mandates a determination of whether the approval
or licensure of the drug addresses “global unmet needs” in the prevention or
treatment of tropical diseases.165 And, similarly for the rare pediatric diseases
voucher program, the report must present a determination of whether the
Sydney Lupkin & Steven Findlay, Winners and Losers with the 21st Century Cures Bill, NPR
(Dec. 2, 2016), http://www.npr.org/sections/health-shots/2016/12/02/504139105/winners-
158. See Russell Berman, Congress Nears a Breakthrough on Medical Research
Funding, THE ATLANTIC (Dec. 1, 2016),
warren/509228/ (describing criticism of the Act); see also Sam Stein, Matt Fuller & Ryan
Grim, Congress Is About to Pass A Bill That Shows D. C. at its Worst — It May Also Turn
Around the Opioid Crisis and Cure Cancer, HUFF. POST (Nov. 29, 2016),
cures_us_583e3d98e4b0ae0e7cdaca32; Ameet Sarpatwari & Michael Sinha, The Current 21st l
Century Cures Legislation Is Still A Bad Deal For Patients, HEALTH AFFS. BLOG (Nov. 30,
159. 21st Century Cures Act, Title II.
160. For an overview of the FDA-specific provisions in the proposed Act, see Brennan,
supra note 48.
161. See Brennan, supra note 48.
162. See 21st Century Cures Act, § 3014 (a).
163. 21st Century Cures Act, § 3014 (b).
164. 21st Century Cures Act, § 3014 (c)( 1)( B).