advantages over existing treatments.”
41 One of these pathways is known as
“priority review” and was created in 1992 by the Prescription Drug User Fee
42 When a drug is granted priority review status, the FDA directs its
“overall attention and resources” to reviewing the application.
43 In practice,
this translates into a shortening of the average review period from ten to six
44 The voucher program inscribes certain drug applications into an
existing category—priority review—for which these drugs might not have
Although engaging in priority review is by now a routine process for the
45 shifting to priority review upon redemption of a voucher does have
an impact on the agency, which has been plagued by funding and staff
shortcomings since well before the voucher system was devised.
46 In the
2006 paper introducing the concept of priority review vouchers, Ridley et
alia estimated that the “cost to the FDA of changing a drug’s status from
standard to priority is approximately $1 million” and proposed a voucher user
41. See FAST TRACK, supra note 25; For Patients: Breakthrough Therapy, U.S. FOOD &
DRUG ADMIN., https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm (last updated
September 15, 2014) (Sponsors of drugs that “treat serious conditions and fill an unmet
medical need” may request fast track designation. Sponsors of drugs treating serious
conditions may request breakthrough therapy designation “when preliminary clinical
evidence indicates that the drug may demonstrate substantial improvement over available
therapy on a clinically significant endpoint(s).” Accelerated approval is available “for drugs
for serious conditions that fill an unmet medical need on whether the drug has an effect on a
surrogate or an intermediate clinical endpoint.”). As indicated above, priority review sets “a
goal date for taking action on an application within 6 months of receipt.” U.S. FOOD & DRUG
ADMIN., REVIEW DESIGNATION POLICY: PRIORITY (P) AND STANDARD (S), MANUAL OF
POLICIES AND PROCEDURES
res/ucm082000.pdf [hereinafter P AND S POLICY MANUAL].
42. Id.; See also Ernst R. Berndt et al., Industry Funding of the FDA: Effects of PDUFA
on Approval Times and Withdrawal Rates, 4 NATURE REVS. DRUG DISCOVERY 545, 546 (July
43. U.S. FOOD & DRUG ADMIN., PRIORITY REVIEW,
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm (last updated Sep. 15, 2014).
44. P AND S POLICY MANUAL, supra note 41, at 2.
45. See Joseph A. DiMasi & Henry G. Grabowski, Economics of New Oncology Drug
Development, 25 J. CLINICAL ONCOLOGY 210, 216 (Jan. 2007) (discussing a 2007 study that
found that 71% of approved oncology drugs had received priority review, whereas for other
drugs the rate was 40%); John K. Jenkins, Regulatory Flexibility and Lessons Learned: Drugs
for Rare Diseases, U.S. FOOD & DRUG ADMIN., 12 (Oct. 18, 2016),
acco/CDER/UCM525805.pdf (showing that during the 2008-2016 period (up to September 7,
2016) the number of NMEs approved under priority review was 75% for rare diseases and
30% for non-rare diseases).
46. See, e.g., Charles Marwick, FDA Funding Problems Imperil Safety of Biological
Products in the United States, 279 JAMA 899, 901 (1998) (discussing the disparity between
the increase between the number of areas FDA has been called to regulate over time and the
amount of funding available to the agency).