approval or licensure of the drug addressed an “unmet need.”166 If a priority
review voucher for medical countermeasures is approved, a similar
determination needs to be made, assessing whether approval or licensure of
a drug “affected the Nation’s preparedness against a chemical, biological,
radiological, or nuclear threat, including naturally occurring threats.”167 The
Act further emphasizes the need by establishing a separate requirement that
the GAO report assess “whether any improvements to such programs are
necessary to appropriately target incentives for the development of drugs that
would likely not otherwise be developed, or developed in as timely a
manner.”168 Collectively, these requirements are more stringent than the ones
that were in place after the GAO’s study of the pediatric voucher program.169
Catering to the concerns periodically voiced by the FDA about the impact
of the voucher programs on its resources, the Act also mandates an evaluation
of “the resources used by the Food and Drug Administration in reviewing
drugs for which vouchers were used, including the effect of the programs on
the Food and Drug Administration’s review of drugs for which priority
review vouchers were not awarded or used.”170
While the 21st Century Cures Act does nothing to directly address the two
main problems associated with the vouchers—lack of R& D on neglected
diseases and affordability—it does provide a better normative framework for
evaluating the successes and failures of the program as an incentives
mechanism. This modest improvement should facilitate informed debate
about the merits of the program in years to come.
B. Revisiting the role of FDA as a locus for incentives policy
In addition to issues that are intrinsic to the awarding and use of the
vouchers, Congress’ use of an agency like the FDA as tool for innovation
policy raises further questions. The FDA has a storied role in pharmaceutical
innovation, but one that is primarily associated with its mission as a
gatekeeper: the main focus of the agency is to ensure that drugs are safe and
effective, a role that is undeniably shaped by underlying policy choices. As
Peter Barton Hutt has written, it “is difficult to find any significant issue faced
by FDA that is not ultimately a matter of policy, informed by both scientific
and legal considerations.”171
166. 21st Century Cures Act, § 3014 (c)( 1)( C)(ii).
167. 21st Century Cures Act, § 3014 (c)( 1)( C)(iii).
168. 21st Century Cures Act, § 3014 (c)( 3)( B).
169. See 21 U.S. C. § 360ff(i)( 1)( B).
170. 21st Century Cures Act, § 3014 (c)( 3)( A).
171. Peter Barton Hutt, Historical Themes and Developments at FDA Over the Past Fifty
Years, FDA IN THE TWENTY-FIRST CENTURY: THE CHALLENGES OF REGULATING DRUGS AND