from another company.
34 In order to expedite review of Praluent, Sanofi
acquired the voucher from BioMarin at a price tag of $67 million, which
indicates that Sanofi expected returns in excess of that amount.
35 In the case
of Odefsey, Gilead obtained the voucher from Knight Therapeutics for $125
million, which puts the estimated return over $130 million.
36 Likewise, the
record-setting transaction in which United sold a (so-far unused) voucher to
AbbVie for $350 million indicates that, in the future, AbbVie expects to gain
approval for a drug that is likely to generate more than that amount after
entering the market four months ahead of standard review.
Year Seller Purchaser Amount
2014 BioMarin Sanofi and Regeneron $67 million
2014 Knight Gilead $125 million
2015 United AbbVie $350 million
2015 Retrophin Sanofi $245 million
2016 Unknown38 Gilead undisclosed
Table 1: Priority Review Voucher Sales
FDA’s mission of ensuring the safety and efficacy of drugs39 is unlikely to
be compromised by the redemption of a voucher per se, as the agency
routinely engages in processes to expedite review of drugs deemed promising
outside the voucher context.
40 The agency has different pathways to speed up
review of drugs that treat “serious medical conditions,” particularly in cases
where such drugs “are the first available treatment or if the drug has
34. Alexander Gaffney et al., Regulatory Explainer: Everything You Need to Know About
FDA’s Priority Review Vouchers, REG. AFF. PROF’LS SOC’Y (Nov. 3, 2016),
35. Id. (explaining that Sanofi expects returns in addition to the voucher user fee).
38. In July of 2016, Gilead indicated that it had purchased a voucher, but did not make
public any information about the sale or plans for its use. See GILEAD SCIENCES, INC., CURRENT
REPORT (FORM 8-K) (July 25, 2016),
UkUmc3Vic2lkPTU3. Some commentators have raised the possibility that this might be the
voucher awarded earlier in 2016 to vaccine company PaxVax Bermuda for Vaxchora, a single-dose oral cholera vaccine. See Gaffney et al, supra note 34.
39. See What We Do: FDA Mission, U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/AboutFDA/What WeDo/ (last updated Apr. 4, 2017).
40. See GUIDANCE FOR INDUSTRY, supra note 23, at 1; see also infra note 41 and