1 See 21st Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033 (2016).

2 Id.

3 See 21 U.S.C. 356 (2016); 21 U.S.C. 351 (2016).

4 See 42 U.S.C. 1395y(1)(5) (2016).

5 Medicare Coverage Decisions & Beneficiary Appeals: Hearing Before the Subcomm. on Health of the Cmty. of the H. Comm on Ways & Means, 106th Cong. 21-130 (1999) (statement of Eleanor D. Kinney, Professor of Law).

6 See Liz Richardson, Health Policy Brief: Aligning FDA and CMS Review, Health Aff., Aug. 27, 2015, at 1-2, https://www.healthaffairs.org/do/10.1377/hpb20150827.132391/full/healthpolicybrief_143.pdf; Kerry Young, Medicare Rejects Most Bids for New Technology Add-On Payments, Wash. Health Pol'y Wkly. Rev. (Aug. 10, 2015), http://www.commonwealthfund.org/publications/newsletters/washington-health-policy-in-review/2015/aug/aug-10-2015/medicare-rejects-most-bids-for-new-technology-addon-payment [https://perma.cc/3DZP-7MYZ].

7 See Richardson, supra note 6 at 2.

8 See Jacqueline Fox, The Hidden Role of Cost: Medicare Decisions, Transparency, and Public Trust, 79 U. Cin. L. Rev. 1, 4-5 (2011); see also Local Coverage Determination Act, H.R. 3635, 115th Cong. (2017) (seeking to improve transparency of Medicare Local Coverage Determination Act).

9 See Richardson, supra note 6 at 2.

10 See Reimbursement Guidelines Medicare: Hearings Before the S. Comm. on Fin., 89th Cong. 76 (1966) (statement of Sen. John Williams); Staff of S. Comm. on Fin., 81st Cong., Medicare and Medicaid: Problems, Issues, and Alternatives, 31-32 (Comm. Print 1970).

11 Foster, Richard S., Trends in Medicare Expenditures and Financial Status, 1966-2000, 22 Health Care Fin. Rev. 35, 39 (2000)Google ScholarPubMed (taking the mean of annual increase for “1966-1969” and “1970-1973”).

12 See, e.g., Balanced Budget Act of 1997, Pub. L. No. 105-33 §§ 4011-4013, 4571, 111 Stat. 251, 334-336, 464 (1997) (lowering growth rates by establishing competitive pricing models hospitals and increased premium contribution for Part B); Tax Equity and Fiscal Responsibility Act of 1982, Pub. L. No. 97-248 § 114, 96 Stat. 324, 341-342 (1982) (introducing Medicare Advantage plans to cut costs).

13 Ben L. Holmes, Current Strategies for the Development of Medical Devices, in 3 Inst. of Medicine, Technology and Health Care in an Era of Limits, 219-220 (Annetine C. Gelijns ed., 1992).

14 Medical Technology Spotlight, SelectUSA, https://www.selectusa.gov/medical-technology-industry-united-states [https://perma.cc/2WKV-ETFR].

15 Id.

16 Id.

17 Stuart Guterman & Michelle P. Serber, The Commonwealth Fund, Enhancing Value in Medicare: Demonstrations and Other Initiatives to Improve the Program, 4 fig.2.

18 Jef Akst, The Elixir Tragedy, 1937, The Scientist (June 1, 2013), http://www.thescientist.com/?articles.view/articleNo/35714/title/The-Elixir-Tragedy—1937 [https://perma.cc/WX9Z-E2QW].

19 See Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (codified as amended at 21 U.S.C. §§ 301-392 (2012)).

20 Id. § 505, 52 Stat. at 1052.

21 The Insight Team, Sunday Times of London, Suffer the Children: Story of Thalidomide 1-2 (1979); see Trent Stephens & Rock Brynner, Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine 21-27 (2001); Philip J. Hilts, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation 144-65 (2004).

22 Kim, James H. & Scialli, Anthony R., Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease, 122 Toxicological Sci. 1, 1 (2011)CrossRefGoogle ScholarPubMed.

23 Frances Oldham Kelsey: Medical Reviewer Famous for Averting Health Tragedy, U.S. Food & Drug Admin., https://www.fda.gov/AboutFDA/WhatWeDo/History/ucm345094.htm [https://perma.cc/3PZX-B4TK].

24 See Drug Amendments Act of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified as amended in scattered sections of 21 U.S.C.).

25 Id. § 102, 76 Stat. at 781.

26 See Nat'l Research Council, The Social Impact of AIDS in the United States, 84-102 (Albert R. Honsen & Jeff Stryker eds., 1993) (explaining the developments in FDA regulations following the AIDS epidemic).

27 See Peter S. Arno & Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics and Profits 10-21 (1992); Neal A. Dickerson, Protocol for a Plague: AIDS Research, Access to Life-Saving Therapies & Drug Approval 17-20, 27-28 (1994); Salbu, Steven R., Regulation of Drug Treatments for HIV and AIDS: A Contractarian Model of Access, 11 Yale J. on Reg. 401, 404-05 (1994)Google Scholar; Lansdale, Bret L., Note, A Procedural Due Process Attack on FDA Regulations: Getting New Drugs to People with AIDS, 18 Hastings Const. L.Q. 417, 417-18 (1991)Google Scholar.

28 Greenberg, Michael D., AIDS, Experimental Drug Approval, and the FDA New Drug Screening Process, 3 N.Y.U. J. Legis. & Pub. Pol'y 295, 296 (2000)Google Scholar. See Revitalizing New Product Development from Clinical Trials Through FDA Review: Hearing on S. 1477 Before the S. Comm. on Labor and Human Resources, 104th Cong. (1996).

29 Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified as amended in scattered sections of 21 U.S.C.).

30 See 21 U.S.C. § 371(h) (2012).

31 Administrative Practices and Procedures; Good Guidance Practices, 65 Fed. Reg. 56,468 (Sept. 19, 2000) (codified in various parts of 21 C.F.R.).

32 21 C.F.R. 10.115(b)(2) (2017).

33 About FDA Guidance Documents, U.S. Food & Drug Admin. (Mar. 30, 2018), https://www.fda.gov/RegulatoryInformation/Guidances/#about [https://perma.cc/D3E7-LEHS]; Industry Notices and Guidance Documents, U.S. Food & Drug Admin. (Feb. 2, 2018), https://www.fda.gov/ForIndustry/IndustryNoticesandGuidanceDocuments/default.htm [https://perma.cc/P4G5-J8UQ].

34 See Merrill, Thomas W. & Watts, Kathryn T., Agency Rules with the Force of Law: The Original Convention, 116 >Harv. L. Rev. 467>, 546-59 (2002)CrossRefGoogle Scholar.

35 See generally Griffin, Jerry C., et al., Medical Technology Development in the 1990s, 18 PACE 1321 (1995)CrossRefGoogle ScholarPubMed (describing the trajectory of medical technology throughout the 1990s).

36 See, e.g., Bernard R. Glick et al., Medical Biotechnology (2014); Mary Keen, Medical Biotechnology (Judit Pongracz & Mary Keen eds., 2009); see also Medical Biotechnology: Premarket and Postmarket Regulation 88-90 (Erika Lietzan ed., 2015); Albert Sasson, Medical Biotechnology: Achievements, Prospects and Perceptions (2005).

37 Van, Gail A. Norman, Drugs and Devices: Comparison of European and U.S. Approval Processes, 5 JACC: Basic to Translational Sci. 399, 406 (2016)Google Scholar (“The EU and United States face some common challenges in balancing the mandate to ensure [drug and device] safety and efficacy against the pressure from industry and the public to expedite the transit of new [drug and device] to market.”).

38 See, e.g., Jay Hancock, Everyone Wants to Reduce Drug Prices. So Why Can't We Do It? N.Y. Times (Sept. 23, 2017), https://www.nytimes.com/2017/09/23/sunday-review/prescription-drugs-prices.html?_r=0; Katherine Hobson, Cost of Medicine: Are High-Tech Medical Devices and Treatments Always Worth It?, U.S News (Jul. 10, 2009), https://health.usnews.com/health-news/best-hospitals/articles/2009/07/10/cost-of-medicine-are-high-tech-medical-devices-and-treatments-always-worth-it; Kim McCleary & Kristin Schneeman, Medical Research and Development Issues to Watch In 2018, Health Aff. (Jan. 31, 2018), https://www.healthaffairs.org/do/10.1377/hblog20180126.879412/full/.

39 Greenberg, supra note 28, at 297.

40 Medical Device Amendments, Pub. L. No. 94-295, 90 Stat. 539 (1976) (codified as amended at scattered sections of 21 U.S.C.); see David W. Feigal, Jr., Appendix D Impact of the Regulatory Framework on Medical Device Development and Innovation, in Inst. of Medicine, Public Health Effectiveness of the FDA 510(k) Clearance Process 113, 116 (Theresa Wizemann ed., 2010); Bradley M. Thompson & Brian A. Dahl, The Food and Drug Administration Review Process for Medical Devices, in Guide To Medicare Coverage Decision-Making and Appeals 41 (Eleanor D. Kinney ed., 2002).

41 See generally Staff of S. Comm. on Fin., supra note 10, at 1 (explaining the financing necessary for Medicare).

42 See Holmes, supra note 13, at 219-20 (“In 1965 the medical device market was relatively small; U.S. Department of Commerce estimates put total sales at around $200 million.”); Medical Technology Spotlight, supra note 14 (“The United States remains the largest medical device market in the world with a market size of around $140 billion, and the U.S. market represented about 40 percent of the global medical device market 2015.”).

43 See Karen M. Hicks, Surviving the Dalkon Shield IUD: Women v. The Pharmaceutical Industry 159-60 (1994) (stating the need to overhaul the FDA in response to the Dalkon Shield).

44 Gina Kolata, The Sad Legacy of the Dalkon Shield, N.Y. Times (Dec. 6, 1987), https://www.nytimes.com/1987/12/06/magazine/the-sad-legacy-of-the-dalkon-shield.html.

45 Statement on Signing the Medical Device Amendments of 1976, 2 Pub. Papers 1765.

46 Medical Device Amendments § 513, 90 Stat. at 540-41.

47 21 U.S.C. § 360c(a) (2012); see Jason Smith & Stephen Barrett, What Are 510(k) Clearance and Premarket Approval?, Device Watch (Apr. 12, 2008), https://www.devicewatch.org/reg/reg.shtml [https://perma.cc/EPQ8-2WKD] (describing the Classes under the MDA).

48 See 21 U.S.C. § 360(a)(1)(C); Premarket Approval (PMA), U.S. Food & Drug Admin. (Mar. 27, 2018), https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/ [https://perma.cc/CZT9-DDGH] (“Clinical investigations section includes study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints”).

49 See PMA Supplements and Amendments, U.S. Food & Drug Admin. (Feb. 15, 2018), https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050467.htm [https://perma.cc/AC9L-FWLQ] (“Amendments (§ 814.37) or supplements (§ 814.39) are submitted to FDA for changes or revisions to the original PMA submission.”).

50 See id.

51 See PMA Review Process, U.S. Food & Drug Admin. (Feb. 22, 2018), https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm047991.htm [https://perma.cc/4BJN-N6X6].

52 See 21 U.S.C. § 360(c) (2012).

53 See 21 C.F.R. § 814.39(a) (2012).

54 See id.

55 21 U.S.C. § 360c(a)(1)-(3) (2012).

56 See Barlas, Stephen, Critics Assail FDA Medical Device Approval Process, 36 J. Clinical Pharmacy & Therapeutics 395, 395 (2011)Google ScholarPubMed (noting delays in the device approval process).

57 See id.

58 See Eleanor D. Kinney, The Affordable Care Act and Medicare in Comparative Context 43 (2015).

59 See id. at 24.

60 42 U.S.C. § 1395y(a) (2012).

61 See Ctrs. For Medicare & Medicaid Servs., Innovators' Guide to Navigating Medicare 11-16 (2010), https://www.cms.gov/CouncilonTechlnnov/Downloads/InnovatorsGuide5_10_10.pdf.

62 Patient Protection and Affordable Care Act § 6301 (codified at 42 U.S.C. 1301 et seq.); see Kinney, Eleanor D., Comparative Effectiveness Research Under the Patient Protection and Affordable Care Act: Can New Bottles Accommodate Old Wine?, 37 Am. J.L. & Med. 522, 527 (2011)CrossRefGoogle ScholarPubMed.

63 See Darrel J. Grinstead, Evolution of the Medicare Coverage Policy-Making Process, in Guide to Medicare Coverage Decision-Making and Appeals 1, 9-13 (Eleanor D. Kinney ed. 2002).

64 See id. at 13.

65 See, e.g., Medicare Program; Hospice Care, 48 Fed. Reg. 38,146 (Dec. 16, 1983).

66 What Is a MAC, Ctrs. For Medicare & Medicaid Servs. (Oct. 26, 2017), https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-MAC.html [https://perma.cc/JD6C-ZTFU]

67 See also Kinney, Eleanor D., National Coverage Policy Under the Medicare Program: Problems and Proposals for Change, 32 St. Louis U. L.J. 869 (1988)Google Scholar; Kinney, Eleanor D., The Medicare Appeals System for Coverage and Payment Disputes: Achieving Fairness in a Time of Constraint, 1 Admin. L.J. 1 (1987)Google Scholar; ABA, Section on Administrative Law and Regulatory Practice, Medicare Appeal Procedures 3 (1988).

68 See, e.g., U.S. Gen. Acct. Off., Medicare Part B: Regional Variation In Denial Rates for Medical Necessity 3-4 (1994); U.S. Gen. Acct. Off., Medicare-Technology Assessment and Medical Coverage Decisions 6-8 (1994).

69 Medicare Program; Criteria and Procedures for Making Medical Services Coverage Decisions that Relate to Health Care Technology, 54 Fed. Reg. 4302, 4308-10 (1989).

70 See id.

71 See Foote, Susan B. & Town, Robert J., Implementing Evidence-Based Medicine Through Medicare Coverage Decisions, 26 Health Aff. 1634, 1635-36 (2007)CrossRefGoogle ScholarPubMed; Peter J. Neumann et al., Medicare's National Coverage Decisions for Technologies, 1999-2007, 27 Health Aff. 1620, 1620-22 (2008); Sean R. Tunis et al., Federal Initiatives to Support Rapid Learning About New Technologies, 26 Health Aff. w140, w140-42 (2007), https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.26.2.w140; Tunis, Sean R. & Pearson, Steven D., Coverage Options for Promising Technologies: Medicare's Coverage with Evidence Development, 25 >Health Aff. 1218, 1219-20 (2006)CrossRefGoogle Scholar.

72 42 U.S.C. § 1395y(a) (2012).

73 See Medicare Program; Revised Process for Making Medicare National Coverage Determinations, 58 Fed. Reg. 55,634 (Sept. 26, 2003).

74 See Medicare Coverage Decisions and Beneficiary Appeals, Hearing Before the Comm. on Ways and Means, 106 Cong. 53 (1999).

75 See Kinney, supra note 58 at 39.

76 See, e.g., Medicare Coverage Decisions & Beneficiary Appeals: Hearing Before the Subcomm. on Health of the Comm. of the H. Comm on Ways & Means, 106th Cong. 21-130 (1999); Patient Appeals in Health Care: Hearing Before the Subcomm. on Health of the Comm. of the H. Comm. on Ways & Means, 105th Cong. 2-96 (1998).

77 See Consolidated Appropriations Act, Pub. L. No. 106-554, § 522(a), 114 Stat. 2763, 2763A-543-47 (2000) (codified as amended 42 U.S.C. § 1395y(a)).

78 See id. §522(b), 114 Stat. 2763, 441-43 (explaining the steps the Secretary needs to take to explain coverage determinations to the public); Kinney, supra note 58 at 40.

79 See Consolidated Appropriations Act § 522(b), 114 Stat. at 2763A–543-47; Kinney, supra note 58, at 40.

80 See Consolidated Appropriations Act § 522(b), 114 Stat. at 2763A–543-47; Kinney, supra note 58, at 40.

81 See Consolidated Appropriations Act § 522(b), 114 Stat. at 2763A–543-47; Kinney, supra note 58, at 40.

82 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (codified at 42. U.S.C § 1395y (2003)).

83 See id. § 731; Kinney, supra note 58, at 40.

84 See Modernization Act § 731, 117 Stat. at 2066.

85 See, e.g., Abigail All. for Better Access to Developmental Drugs v. Von Eschenbach, 495 F.3d 695, 700 (D.C. Cir. 2007); Jacobson, Peter D. & Parmet, Wendy E., A New Era of Unapproved Drugs: The Case of Abigail Alliance v Von Eschenbach, 297 JAMA 205, 205 (2007)CrossRefGoogle ScholarPubMed.

86 National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1), Ctrs. for Medicare and Medicaid Servs. (July 9, 2007), https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&bc=BAABAAAAAAAA [https://perma.cc/C3YQP72C].

87 Kinney, supra note 58, at 41.

88 See Foote & Town, supra note 71 at 1636; see also Tunis, Sean R., A Clinical Research Strategy to Support Shared Decision Making, 24 Health Aff. 180, 181-82 (2005)CrossRefGoogle ScholarPubMed (stating the expansion of Medicare coverage for medical devices was aimed at allowing more information could be obtained about risks and benefits); Tunis, Sean R. et al., Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy, 290 JAMA 1624, 1628-29 (2003)CrossRefGoogle ScholarPubMed (explaining the regulations governing how medical devices can be used within clinical trials).

89 Ctrs. for Medicare and Medicaid Servs., National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development 1 (2006), https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/ [https://perma.cc/CUM8-CBG4].

90 Kinney, supra note 58, at 42.

91 Id.

92 Id.

93 Id.; see Consolidated Appropriations Act, Pub. L. No. 106-554, § 522(a) 114 Stat. 2763, 2763A-543 (2000).

94 See Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (codified at 42. U.S.C § 1395y (2003)); Kinney, supra note 58, at 42.

95 Medicare Coverage Center, Ctrs. for Medicare and Medicaid Servs, https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html [https://perma.cc/8YRU-2EN9] (last visited Mar. 24, 2018).

96 Id.

97 21st Century Cures Act, Pub. L. No. 114-225, § 515(c), 130 Stat. 1033, 1121 (2016) (codified at scattered sections of 21 U.S.C.).

98 See 21st Century Cures Act, U.S. Food & Drug Admin. (Sept. 14, 2017), https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/default.htm [https://perma.cc/YS2W-3W2Q].

99 See id.

100 See 21st Century Cures Act, § 3001, 130 Stat. at 1083 (outlining how the Secretary HHS, acting through the Commissioner of the FDA, will evaluate the qualifications of new drug development tools).

101 21st Century Cures Act, Pub. L. No. 114-225, 130 Stat. 1033 (2016).

102 U.S. House of Rep. Comm. on Energy and Com., The 21^st Century Cures Act (2016), https://archives-energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/documents/114/analysis/20161128%20Cures%20Fact%20Sheet.pdf.

103 Id.; H.R. Rep. No. 114-190, pt. 1, at 85 (2015).

104 21st Century Cures Act, 130 Stat. at 1121-30.

105 Republicans Look to Toss Medical Device Excise Tax, Mass Device (Jan. 28, 2011), https://www.massdevice.com/republicans-look-toss-medical-device-excise-tax/ [https://perma.cc/JJ8ZGW82] (describing Republican push for medical device reform).

106 In addition to the Cures Act, the table relies upon the House Energy and Commerce Comm., Division A: 21st Century Cures (2016), https://rules.house.gov/sites/republicans.rules.house.gov/files/114/PDF/114-SAHR34-Sxs.pdf.

107 U.S. Food & Drug Admin., Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff (2017), https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM581664.pdf. When final, this guidance will supersede U.S. Food & Drug Admin, Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Apr. 13, 2015).

108 21st Century Cures Act, Pub. L. No. 114-225, § 3051, 130 Stat. 1033, (2016).

109 21st Century Cures Act 130 Stat. 1033.

110 Id. § 3051(a).

111 Id,

112 Id.

113 Id.

114 See 21st Century Cures Act, Pub. L. No. 114-225, § 3051, 130 Stat. 1033, (2016).

115 Avorn, Jerry & Aaron Kesselheim, The 21st Century Cures Act Will it Take Us Back In Time?, 372 New Eng. J. Med. 2473, 2475 (2015)CrossRefGoogle Scholar.

116 See 21st Century Cures Act § 3052, 130 Stat. 1033 (increasing number of humanitarian device exemptions from 4,000 to 8,000); 21 U.S.C. § 360j.

117 Id.; see 21 U.S.C. § 360j(m)(2)(C).

118 Id.

119 Id.

120 See id. § 3053, 130 Stat. at 21 U.S.C. § 360d(c).

121 Id.

122 See id. § 3053(b) (describing ongoing review and update of standard operating procedures identifying the principles for recognizing standards by the FDA).

123 21st Century Cures Act, Pub. L. No. 114-225, 130 Stat. 1033 § 3054 (2016); 21 U.S.C. § 360(l).

124 See 21st Century Cures Act § 3055; 21 U.S.C. § 360c(b).

125 21st Century Cures Act § 3055, 130 Stat. 1033.

126 Id.

127 Id.

128 21 U.S.C. § 360j (2010).

129 Arnold & Porter, The 21st Century Cures Act (Dec. 2016) https://www.arnoldporter.com/en/perspectives/publications/2016/12/~/media/494845acdab34e79b4ee0ca6c486856a.

130 21 U.S.C. § 360c (2018).

131 Id.

132 21st Century Cures Act, Pub. L. No. 114-255, §3058, 130 Stat. 1033 (2016).

133 Id.

134 Id.

135 Id.

136 Id.

137 Id.

138 21st Century Cures Act, Pub. L. No. 114-255, §3058, 130 Stat. 1033 (2016).

139 Id.

140 Id. § 3057.

141 Id. §§ 3059, 3060.

142 See Foote, Susan B., Focus on Locus: Evolution of Medicare's Local Coverage Policy, 22 Health Aff. 137, 138 (2003)CrossRefGoogle ScholarPubMed.

143 U.S. Gen. Accounting Office, GAO-03-175, Medicare: Divided Authority for Policies on Coverage of Procedures and Devices Result in Inequities (2003).

144 Medicare Prescription Drug, Improvement, and Modernization Act Pub. L. No. 108-173, § 731(a)(1)(B), 117 Stat. 2066 (codified as 42 U.S.C. § 1395y(l)(5)).

145 Id.

146 Id.

147 21st Century Cures Act, Pub. L. No. 114-255, §4010, 130 Stat. 1033 (2016).

148 See id.

149 See id.

150 See id.

151 See id.

152 See 21st Century Cures Act, Pub. L. No. 114-55, §4011, 130 Stat. 1033 (2016).

153 See id.

154 See Med. Device Mfr. Ass'n., 2016 Annual Report: 25 Years of Passionate Advocacy 1-6 (2017), http://c.ymcdn.com/sites/www.medicaldevices.org/resource/resmgr/annual_reports/MDMA_2016_Annual_Report.pdf; Richard Williams et al., Mercatus Research, US Medical Devices: Choices and Consequences 6 (2015), https://www.mercatus.org/system/files/Williams-Medical-Devices.pdf.

155 See Inst. of Med., Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation 93 (2010); Inst. of Med., The Changing Economics of Medical Technology 2-4 (1991); Inst. of Med. Medical Technology Assessment Directory: A Pilot Reference To Organizations, Assessments, and Information Resources 9-12 (1988).

156 See discussion supra Part II.

157 See Public Health Effectiveness supra note 155.

158 See Innovators' Guide supra note 61, at 5-9.

159 See id. at 35-36.

160 See, e.g., Paul Brown, Tracy Rupp and Steven Findlay, Congress Shouldn't Pass the 21st Century Cures Act in a Summer Rush, Health Aff. Blog (Jul. 11, 2016), https://www.healthaffairs.org/do/10.1377/hblog20160711.055786/full/; Julia Boccagno, House Passes Most Lobbied Bill in Recent History, Heads to Senate, CBS News (Nov. 30, 2016), https://www.cbsnews.com/news/most-lobbied-bill-in-recent-history-makes-its-way-to-house-floor-for-a-vote/; Sydney Lupkin & Steven Findlay, Winners and Losers with the 21st Century Cures Bill, NPR (Dec. 2, 2016), https://www.npr.org/sections/health-shots/2016/12/02/504139105/winners-and-losers-if-21st-century-cures-bill-becomes-law [https://perma.cc/7E64-2HUY].

161 See supra note 160.

162 Lupkin & Findlay, supra note 160.

163 Avorn & Kesselheim, supra note 115.

164 See Laura Masterson, Note, The Future of Medical Device Patents: Categorical Exclusion After Ebay, Inc. V. Mercexchange, L.L.C., 20 B.U. J. Sci. & Tech. L. 274, 276-77 (2014); Duff Wilson, Drug Firms Face Billions in Losses in 2011 as Patents End, N.Y. Times (March 6, 2011), https://www.nytimes.com/2011/03/07/business/07drug.html.

165 See supra note 154.

166 Press Release, Med. Device Mfr. Ass'n, MDMA Response to President Trump's State of the Union Address (Jan. 31, 2018).

167 See Brown et al., supra note 160.

168 See id.

169 See Milestones in U.S. Food and Drug Law History, U.S. Food & Drug Admin. (Feb. 1, 2018), https://www.fda.gov/AboutFDA/WhatWeDo/History/FOrgsHistory/EvolvingPowers/ucm2007256.htm [https://perma.cc/X267-9NDC].

170 See Marsh v. Oregon Nat. Res. Counsel, 490 U.S. 360, 378 (1989).

171 See id.

172 401 U.S. 402.

173 See Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (1971).

174 Id. at 415-416.

175 463 U.S. 29.

176 Motor Vehicle Mfr. Ass'n of the United States, Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983).

177 Id. at 43.

178 See, e.g., Ethyl Corp. v. EPA, 541 F.2d 1, 16 (D.C. Cir. 1976); Nat. Res. Def. Council, Inc. v. United States Nuclear Regulatory Comm'n, 547 F.2d 633, 642-46 (D.C. Cir. 1976).

179 Bazelon, David C., Coping with Technology Through the Legal Process, 62 Cornell L. Rev. 817, 819 (1977)Google Scholar.

180 Vermont Yankee Nuclear Power Corp. v. Nat'l Res. Def. Council, 435 U.S. 519 (1978).

181 See Stewart, Richard B., Vermont Yankee and the Evolution of Administrative Procedure, 91 Harv. L. Rev. 1805, 1816-19 (1978)CrossRefGoogle Scholar.

182 547 F.2d 633.

183 Id. at 653.

184 435 U.S. 519.

185 See Jonathan Bastable, Amazing & Extraordinary Facts – Prime Ministers 21 (2011) (noting that after a review of Churchill's writings, speeches and other statements, this quote was not found).

186 Alina Selyukh, Who Oversees the President's Ethics? Here's Our List, NPR (Mar. 27, 2017), https://www.npr.org/2017/03/27/520983699/who-oversees-the-president-s-ethics-a-reference-sheet [https://perma.cc/QSQ3-K5M6]; Interview with Walter Schaub, Former Director of the U.S. Office of Government Ethics, Center for the Advancement of Public Integrity (2017), http://www.law.columbia.edu/sites/default/files/microsites/public-integrity/ethical_issues_in_the_trump_era.pdf.

187 See, e.g., Nicholas Kristof, The Trump Stain Spreads, N.Y. Times, (Feb. 14, 2018), https://www.nytimes.com/2018/02/14/opinion/porter-trump-domestic-violence.html; So-Young Kang, The True Meaning of Integrity, Huffington Post Blog (Dec. 6, 2017), https://www.huffingtonpost.com/soyoung-kang/the-true-meaning-of-integ_b_11273420.html [https://perma.cc/U2CC-E5Q6]; Paul Krugman, Ideology and Integrity, N.Y. Times (May 1, 2015), https://www.nytimes.com/2015/05/01/opinion/paul-krugman-ideology-and-integrity.html.

188 See, e.g., Alan Montefiore & David Vines, Integrity in the Public and Private Domains (1999); Roberts N. Roberts and Marion T. Doss Jr., Watergate to Whitewater: The Public Integrity War (1997); Steven L. Carter, Integrity (1996); see also The Integrity Project, https://integrityproject.org/ [https://perma.cc/NQ7B-TSLB].

189 Damian Cox, et al., Integrity, The Stanford Encyclopedia of Philosophy (Feb. 20, 2017), https://plato.stanford.edu/entries/integrity/ [https://perma.cc/QG62-S5XR].

190 Amber Carpenter, Plato: Portraits of Integrity, The Integrity Project (May 2, 2014), https://integrityproject.org/2014/05/02/recording-of-plato-introduction/ [https://perma.cc/TZF7-SZFZ].

191 See Cox et al., supra note 190.

192 Integrity, Cambridge Dictionary (2018).

193 See Cox et al., supra note 190.

194 Mark Halfon, Integrity: A Philosophical Inquiry 37 (1989).

195 Integrity, Cambridge Dictionary (2018); see Rose, Jonathan & Heywood, Paul M., Political Science Approaches to Integrity and Corruption, 23 Hum. Aff. 148, 157 (2013)Google Scholar.

196 See Bazelon, supra note 179 at 824.