1 2014 Ebola Outbreak in West Africa, CDC, http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html [http://perma.cc/XP3Z-N799].

2 Michael McLaughlin, Finally, the Deadliest Ebola Outbreak is Almost Over: After More Than 100,000 Deaths, There Are Only a Few Remaining Cases, Huffington Post (Dec. 29, 2015, 6:37 PM), http://www.huffingtonpost.com/entry/ebola-outbreak-2015_us_5682ee8ee4b06fa6888155fe [http://perma.cc/HW8W-BNPT]; see 2014 Ebola Outbreak in West Africa – Reported Cases Graphs, CDC, http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/cumulative-cases-graphs.html [http://perma.cc/L86F-U2PS].

3 Ebola: Mapping the Outbreak, BBC News (Jan. 14, 2016), http://www.bbc.com/news/world-africa-28755033 [http://perma.cc/ZD87-8LDU].

4 Cases of Ebola Diagnosed in the United States, CDC, http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/united-states-imported-case.html [http://perma.cc/4JRQ-T8QZ].

5 See, e.g., Update on the U.S. Public Health Response to the Ebola Outbreak: Hearing Before the H. Comm. on Energy and Commerce & the Subcomm. on Oversight and Investigations, 113th Cong. (2014); Examining the U.S. Public Health Response to the Ebola Outbreak: Hearing Before the H. Comm. on Energy and Commerce & the Subcomm. on Oversight and Investigations, 113th Cong. (2014); Ebola in West Africa: A Global Challenge and Public Health Threat: Hearing Before the S. Comm. on Health, Education, Labor, and Pensions and the Subcomm. on Labor, Health and Human Services, Education and Related Agencies, Comm. on Appropriations, 113th Cong, (2014) (statement of Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases, NIH) [hereinafter Senate Hearing on Ebola]. In an effort to provide greater coordination regarding the U.S. response, the White House appointed an “Ebola Czar” to manage the efforts of the U.S. CDC, National Institutes of Health (“NIH”), Department of Health and Human Services (“HHS”), Department of Defense (“DOD”), Department of Homeland Security (“DHS”), and other U.S. agencies responsible for outbreak response and containment. See Jake Tapper, Obama Will Name Ron Klain as Ebola Czar, CNN (Oct. 19, 2014), http://www.cnn.com/2014/10/17/politics/ebola-czar-ron-klain/ [http://perma.cc/L2JT-ZSGT].

6 See Select Agents and Toxins List, CDC, USDA Federal Select Agent Program, http://www.selectagents.gov/SelectAgentsandToxinsList.html [http://perma.cc/N9XC-CB3P] (listing Ebola and Marbug Virus as Tier 1 toxins).

7 See Senate Hearing on Ebola, supra note 5, at 3-5.

8 Doctors Give 3rd U.S. Ebola Patient “Great” News, Associated Press (Sept. 26, 2014), http://www.cbsnews.com/news/rick-sacra-american-ebola-patient-released-from-nebraska-hospital/ [http://perma.cc/S55N-N5H3]. Further, a recent study also found that serum therapy for the treatment of Ebola was not effective, and that the most effective frequency of administration of the serum therapy is currently unknown. van Griensven, J. et al., Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea, 374 New Eng. J. Med. 33, 33, 41 (2016)Google Scholar.

9 Monte Morin, WHO Endorses Blood Transfusions to Combat Ebola, Despite Skepticism, L.A. Times (Sept. 5, 2014), http://www.latimes.com/science/la-sci-ebola-blood-transfusions-20140906-story.html [http://perma.cc/SK5U-Y75H].

10 See Senate Hearing on Ebola, supra note 5, at 7-10. “Currently, supportive care, including careful attention to fluid and electrolyte replacement, is the only effective medical intervention for patients with Ebola virus disease; no drugs are available specifically to treat Ebola virus infection.” Id. at 5.

11 See Naina Bajekal, Ebola Treatment Clinical Trials to Start in West Africa, Time (Nov. 13, 2014), http://time.com/3583081/ebola-clinical-trials-west-africa-msf/ [http://perma.cc/V7DK-A8KV].

12 See David Ridley, How to Put an Ebola Treatment on Drugmakers’ Radar, SF Gate (Oct. 12, 2014, 10:45 PM), http://www.sfgate.com/opinion/openforum/article/Congress-should-offer-vouchers-to-develop-ebola-5818174.php [http://perma.cc/B4L4-GUJZ].

13 See Adding Ebola to the FDA Priority Review Voucher Program Act, Pub. L. No. 113-233, 128 Stat. 2127 (2014).

14 See id.; Alexander Gaffney, Obama Signs Special Ebola Incentive Program into Law, Regulatory Affairs Professionals Society (Dec. 18, 2014), http://www.raps.org/Regulatory-Focus/News/2014/12/18/20999/Obama-Signs-Special-Ebola-Incentive-Program-Into-Law/ [http://perma.cc/6V3E-KS2E].

15 See Alexander Gaffney & Michael Mezher, Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers, Regulatory Affairs Professionals Society (July 2, 2015), http://www.raps.org/Regulatory-Focus/News/2015/07/02/21722/Regulatory-Explainer-Everything-You-Need-to-Know-About-FDA%E2%80%99s-Priority-Review-Vouchers/ [http://perma.cc/UQS5-876Z].

16 See generally Ridley, David B. et al., Developing Drugs for Developing Countries, 25 Health Aff 313 (2006)Google Scholar; see infra tbl. 1 for a complete timetable of key PRV activities.

17 See 21 U.S.C. § 360n(a)(3) (2012 & Supp. II 2014).

18 Id. § 360ff.

19 Gaffney & Mezher, supra note 15 (quoting 21 U.S.C. § 360n(a)(3)(R) (2012 & Supp. II 2014)) (internal quotation marks omitted).

20 See id.

21 Gaffney & Mezher, supra note 15; see 21 U.S.C. § 360n (2012).

22 Gaffney & Mezher, supra note 15; see 21 U.S.C. §§ 360bb(a)(2), 360ff.

23 See Alexander J. Varond, New Life for the Pediatric Priority Review Voucher Program, FDA Law Blog (Dec. 29, 2015), http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/12/new-life-for-the-pediatric-priority-review-voucher-program.html [http://perma.cc/NXV9-P78T] (The original rare pediatric disease PRV was set to expire within one year of the third PRV being awarded by the FDA for a rare pediatric disease. This date was originally set to be March, 2016, but has since been extended to September 30, 2016).

24 “Filoviruses belong to a virus family called Filoviridae and can cause severe hemorrhagic fever in humans and nonhuman primates. So far, only two members of this virus family have been identified: Marburgvirus and Ebolavirus.” Viral Hemorrhagic Fevers (VHFs): Filovirade, CDC, http://www.cdc.gov/vhf/virus-families/filoviridae.html [http://perma.cc/JZU7-XAM2].

25 Press Release, The White House, Office of the Press Secretary, Statement by the Press Secretary on Bills Signed into Law (Dec. 16, 2014), http://www.whitehouse.gov/the-press-office/2014/12/16/statement-press-secretary-bills-signed-law [http://perma.cc/4MYX-YSL9]; see 21 U.S.C. § 360n(a)(3)(Q) (2012 & Supp. II 2014).

26 Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act, 80 Fed. Reg. 50,559, 50,559-60 (Aug. 20, 2015) (to be codified at 21 C.F.R. pt. 317).

27 21 U.S.C. 360n(a)(3) (2012 & Supp. II 2014); Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act, 80 Fed. Reg. at 50,559-60. The full list of diseases eligible for a PRV include the following: Blinding trachoma, Buruli Ulcer, Chagas (added in 2015 by FDA), Cholera, Dengue, Dracunculiasis, Fascioliasis, Filoviruses (including Ebola) (added in 2014 through legislation), Human African trypanosomiasis, Leishmaniasis, Leprosy, Lymphatic filariasis, Malaria, Neurocysticercosis (added in 2015 by FDA), Onchocerciasis, Schistosomiasis, Soil transmitted helminthiasis, Tuberculosis, Yaws, RPDs (added in 2012 through legislation). 21 U.S.C. 360n(a)(3) (2012 & Supp. II 2014); Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act, 80 Fed. Reg. at 50,559-60.

28 See FDA, Draft Guidance: Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry 7 (2014), http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM423325.pdf. FDA hopes to review and act on 90 percent of the applications that have been granted priority review status within six months, as opposed to ten months for standard review. FDA, PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017 4 (2011), http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.

29 Priority Review, FDA, http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm [http://perma.cc/YS5M-EASC] [hereinafter Priority Review, FDA].

30 Id.

31 Id.

32 Ridley et al., supra note 16, at 314; Priority Review, FDA, supra note 29.

33 HHS et al., Guidance for Industry: Tropical Disease Priority Review Vouchers Draft (2008) 5, http://www.fda.gov/downloads/Drugs/.../Guidances/UCM080599.pdf [http://perma.cc/L2NH-BLH3]. The transferability of a PRV undertook several iterations: as first passed under FDAAA, the PRV was limited to one sale or transfer after being awarded by FDA. Gaffney & Mezher, supra note 15. FDA further clarified that while this limitation exists, they do not believe this precludes the ability of companies to option a license to use the voucher to other companies multiple times. HHS et al., supra. The Food & Drug Administration Safety and Innovation Act of 2012 specified that PRVs awarded for rare pediatric diseases could be sold multiple times. Gaffney & Mezher, supra note 15. Finally, Congress aligned the tropical disease voucher program to the rare pediatric disease voucher in 2014 such that both types of PRVs could be sold multiple times. Gaffney & Mezher, supra note 15.

34 HHS et al., supra note 33.

35 “The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (‘drug’) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes ‘orphan status’).” Designating an Orphan Product: Drugs and Biological Products, FDA, http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm [http://perma.cc/8LWB-VXJV].

36 Andrew S. Robertson et al., The Impact of the US Priority Review Voucher on Private-Sector Investment in Global Health Research and Development, PLoS, Aug. 2012, at 1.

37 Bill Gates, Co-chair & Trustee, Bill & Melinda Gates Foundation, Remarks at the 2008 World Economic Forum (Jan. 24, 2008) (“But some of the highest-leverage work that government can do is to set policy and disburse funds in ways that create market incentives for business activity that improves the lives of the poor. Under a law signed by President Bush last year, any drug company that develops a new treatment for a neglected disease like malaria or TB can get priority review from the Food and Drug Administration for another product they've made. If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier. This priority review could be worth hundreds of millions of dollars.”).

38 See, e.g., Gingery, Derrick Priority Review Voucher's Uncertain Value May Hinder Development, Pink Sheet Daily (Nov. 29, 2010)Google Scholar (“It is the continued relatively unknown nature of the voucher that is causing the problem ….”); Kesselheim, Aaron S., Drug Development for Neglected Diseases — The Trouble with FDA Review Vouchers. 359 New Engl J. Med. 1981-82 (2008)CrossRefGoogle Scholar; Robertson et al., supra note 36, at 1.

39 Robertson et al., supra note 36, at 1.

40 Id. (citation omitted); see Press Release, Novartis International AG, FDA Requests Additional Clinical Data on Novartis Drug ACZ885 for the Treatment of Gouty Arthritis (Aug. 29, 2011), http://www.reuters.com/article/idUS44726+29-Aug-2011+HUG20110829 [http://perma.cc/FTM3-8XJL].

41 Robertson et al., supra note 36, at 1 (citation omitted); see Press Release, Novartis International AG, supra note 40.

42 Id.

43 Id. at 1-2.

44 Id. at 4 fig. 2.

45 See id. at 2, 5.

46 Sutter, Sue, For Sale: Knight Therapeutics Seeks Buyers for Impavido Priority Review Voucher, Pink Sheet Daily (Mar. 20, 2014)Google Scholar.

47 Ron Winslow & Joseph Walker, Drug Firms Buy $67.5 Million Voucher to Speed FDA Review, Wall St. J. (July 30, 2014), http://www.wsj.com/articles/sanofi-regenerons-alirocumab-shows-promise-in-phase-iii-trials-1406738434.

48 Ed Silverman, How Much? Gilead Pays $125M for an FDA Priority Review Voucher, Wall St. J. (Nov. 19, 2014), http://blogs.wsj.com/pharmalot/2014/11/19/how-much-gilead-pays-125m-for-an-fda-priority-review-voucher/.

49 E.g., Sutter, supra note 46.

50 Chelsey Dulaney, Retrophin Sells FDA Voucher to Sanofi for $245 Million, Wall St. J. (May 27, 2015), http://www.wsj.com/articles/retrophin-sells-fda-voucher-to-sanofi-for-245-million-1432732325; Scott Hensley, Price Rises for Ticket to a Quicker Drug Review by FDA, NPR (Aug. 19, 2015), http://www.npr.org/sections/health-shots/2015/08/19/432887081/price-rises-for-ticket-to-a-quicker-drug-review-by-fda.

51 See Priority Review Voucher, priorityreviewvoucher.org [http://perma.cc/659R-ABUB].

52 Id.

53 Varond, supra note 23. The RPD voucher program contains an initial sunset clause, originally set to expire the program one year from the time the third RPD-PRV had been issued. 21 U.S.C. § 360ff(b)(5) (2012).

54 E.g., Advancing Hope Act of 2015, S. 1878, 114th Cong. § 2 (2015); 21st Century Cures Act, H.R. 6, 114th Cong. § 2152 (as referred to the S. Comm. on Health, Education, Labor, and Pensions, July, 13, 2015).

55 See, e.g., S. 1878 (proposing adding sickle-cell anemia for eligibility for priority review vouchers); Zachary Brennan, Congressional Support for Priority Review Vouchers Presses on Despite FDA Qualms, Regulatory Affairs Professionals Society (Mar. 18, 2016), http://www.raps.org/Regulatory-Focus/News/2016/03/18/24581/Congressional-Support-for-Priority-Review-Vouchers-Presses-On-Despite-FDA-Qualms/ [https://perma.cc/3ZVN-5J7U].

56 See, e.g., Matheny, Jason et al., Incentives for Biodefense Countermeasure Development, 5 Biosecurity & Bioterrorism: Biodefense Strategy, Prac. & Sci. 228 (2007)Google Scholar (recommending PRV eligibility for biodefense products); Renwick, Matthew J. et al., A Systematic Review and Critical Assessment of Incentive Strategies for Discovery and Development of Novel Antibiotics, 69 J. Antibiotics 73 (2016)Google Scholar (discussing PRVs as a possible incentive for investment in novel antibiotics).

57 S. 2512, 114th Cong. (2016) (enacted); Jeannie Baumann, Bill Would Add Zika Virus to FDA Priority Review Program, Bloomberg BNA (Feb. 3, 2013), http://www.bna.com/bill-add-zika-n57982066889/ [http://perma.cc/X5U6-SXWW]; see Maggie Fox, WHO Declares Zika a Public Health Emergency, NBC News (Feb. 1, 2016), http://www.nbcnews.com/storyline/zika-virus-outbreak/who-declares-zika-public-health-emergency-n508761 [http://perma.cc/FJ6K-L8FN].

58 Brennan, supra note 55.

59 See supra Part II.A.

60 See Robertson et al., supra note 36, at 4.

61 See Priority Review Voucher, supra note 51.

62 See Robertson et al., supra note 36, at 3.

63 See id. at 3.

64 Medical Countermeasure Innovation Act of 2016, S. 2055, 114th Cong. § 7 (as reported by S. Comm. on Health, Educ., Labor and Pensions, Mar. 14, 2016).

65 Advancing Hope Act of 2015, H.R. 1537, 114th Cong. § 2 (2015).

66 Michael McCaughan, Priority Review Vouchers: FDA has “Concerns”, The RPM Report (Oct. 6, 2015), http://www.pharmamedtechbi.com/publications/rpm-report/first-take/2015/4/priority-review-vouchers-interview [http://perma.cc/58HL-XT96] (quoting John Jenkins, FDA Office of New Drugs Director).

67 Hensley, supra note 50 (discussing vouchers that sold for $125 million, $245 million, and $350 million).

68 See Drugs.com, http://www.drugs.com [http://perma.cc/GV9G-S685].

69 See Drugs@FDA Data Files, FDA, http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm [http://perma.cc/B873-25GK].

70 See Priority Review, FDA, supra note 29.

71 Henry G. Grabowski et al., Priority Review Vouchers to Encourage Innovation for Neglected Diseases, Pharmaceuticals in the Asia Pacific Stanford University Conference 12 (2008), http://www.bvgh.org/LinkClick.aspx?fileticket=9MzDoyIx7pU=&tabid=125 [http://perma.cc/4CGQ-KKT5].

72 See, e.g., Larry Husten, Sanofi and Regeneron Leapfrog Amgen in New Cholesterol Drug Race, Forbes (Jan. 26, 2015), http://www.forbes.com/sites/larryhusten/2015/01/26/sanofi-and-regeneron-leapfrog-amgen-in-new-cholesterol-drug-race/#5b7c6fb76acc (“Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.”); Sy Mukherjee, Sanofi Cashes in $245M Review Voucher to Leapfrog Novo in Crucial Diabetes Combo Race, BioPharma Dive (Feb. 24, 2016), http://www.biopharmadive.com/news/sanofi-cashes-in-245m-review-voucher-to-leapfrog-novo-in-crucial-diabetes/414450/ [http://perma.cc/6S9F-YVWJ] (“Four extra months can prove to be an eternity when it comes to drug marketing. And Sanofi clearly thinks that the lead time will help buoy a once-dominant diabetes franchise that's been hit with accelerating headwinds.”).

73 See, e.g., Myoung Cha & Flora Yu, Pharma’s First-to-Market Advantage, McKinsey & Company (Sept. 2014), http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharmas-first-to-market-advantage [http://perma.cc/G6EC-KNSS] (discussing “greater-than-fair market share” as a first-to-market advantage); John LaMattina, BCG Weighs in on First-in-Class vs. Best-in-Class Drugs – How Valuable Is Their Advice?, Forbes (June 17, 2013), http://www.forbes.com/sites/johnlamattina/2013/06/17/bcg-weighs-in-on-first-in-class-vs-best-in-class-drugs-how-valuable-is-their-advice/#536924926f90 (discussing commercial success for “first-in-class and best-in-class” drugs); Schulze, Ulrik & Ringel, Michael, What Matters Most in Commercial Success: First-in-Class or Best-in-Class?, 12 Nature Reviews: Drug Discovery 419 (2013)Google Scholar (comparing commercial success for “first-in-class” and “best-in-class” pharmaceutical products).

74 Supra Part III.A.

75 See Berndt, Ernst R. et al., Industry Funding of the FDA: Effects of PDUFA on Approval Times and Withdrawal Rates, 4 Nature Reviews: Drug Discovery 545 (2005)Google Scholar for a study evaluating the FDA approval rates of drugs before and after PDUFA.

76 This variable could be adjusted depending on company’s relative risk tolerance.

77 These findings were further spot-checked with known databases for confirmation. See Pharmaceutical Sales 2005, http://www.drugs.com/top200_2005.htm [http://perma.cc/3JCE-WJGD].

78 “Minimum justifiable purchase price” is the lowest price that a company looking to sell a voucher should expect given the number of voucher awards available for purchase and assuming the purchaser would still realize a net benefit through use of the voucher. “Median justifiable purchase price” is the price that fifty percent of companies looking to sell a voucher should expect to exceed, given the number of voucher awards available for purchase and assuming the purchaser would still realize a net benefit through use of the voucher.

79 Fifteen and twenty top products correspond to scenarios where 3 and 4 PRVs would be awarded per the 5 year period.

80 Cha & Yu, supra note 73.

81 Id.

82 Peter Loftus, Drug Makers Buy Pricey Vouchers to Speed Products to Market, Wall St. J. (Nov. 1, 2015), http://www.wsj.com/articles/drug-firms-buy-pricey-vouchers-to-speed-products-to-market-1445333403.

83 Cha & Yu, supra note 73.

84 Schulze & Ringel, supra note 73, at 419.

85 See Priority Review, FDA, supra note 29.

86 See supra text accompanying notes 54-58.

87 See supra text accompanying notes 54-58.

88 Ebola Vaccines, Therapies, and Diagnostics, Questions and Answers, WHO (Oct. 6, 2015), http://www.who.int/medicines/emp_ebola_q_as/en/ [http://perma.cc/KW44-2T3B].

89 See generally WHO, Categorization and Prioritization of Drugs for Consideration for Testing or Use in Patients Infected with Ebola (2015), http://www.who.int/medicines/ebola-treatment/2015_0703TablesofEbolaDrugs.pdf?ua=1 [http://perma.cc/YC6Q-NEZF]. The WHO has also initiated efforts to develop vaccines, therapies, and diagnostic tests for the Zika virus. WHO, Zika Outbreak: WHO’s Emergency Response Plan (Mar. 3, 2016), http://www.who.int/emergencies/zika-virus/response/en/.

90 Rianna Stefanakis et al., Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade, 6 PLoS, Oct. 2012, at 3-5; see 21 U.S.C. § 360n(a)(3) (2012). There are currently seventeen tropical diseases eligible for PRVs listed. 21 U.S.C. § 360n(a)(3) (2012 & Supp. II 2014).

91 U.S. Gov’t Accountability Off., GAO-16-319, Report to Congressional Committees, RARE DISEASES: Too Early to Gauge Effectiveness of FDA’s Pediatric Voucher Program 10 (2016).

92 See, e.g., Sonderholm, Jorn, In Defense of Priority Review Vouchers, 23 Bioethics 413 (2009)Google Scholar (concluding “that the amended PRV scheme constitutes an attractive way of stimulating R&D of drugs for neglected diseases”); Wamstad, Kyle, Note, Priority Review Vouchers – A Piece of the Incentive Puzzle, 14 Va. J.L. & Tech. 126 (2009)Google Scholar (concluding that PRVs encourage innovation).

93 See supra Part II.B.

94 John Carroll, AstraZeneca Nabs Priority Review Voucher as Wellstat Bags FDA OK, FierceBiotech (Sept. 8, 2015), http://www.fiercebiotech.com/story/astrazeneca-nabs-priority-review-voucher-wellstat-bags-fda-ok/2015-09-08 [http://perma.cc/3369-XP63].

95 See supra text accompanying note 38.