Hostname: page-component-cd9895bd7-jn8rn Total loading time: 0 Render date: 2024-12-26T08:16:19.398Z Has data issue: false hasContentIssue false
  • English
  • Français

Public Participation in Drafting of the 21st Century Cures Act

Published online by Cambridge University Press:  01 January 2021

Thomas J. Hwang ,
Rachel E. Sachs  and
Aaron S. Kesselheim
Get access Rights & Permissions [Opens in a new window]

Abstract

The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group lobbying, but the bill and the key changes made during its drafting remain controversial. Using publicly disclosed records of written comments on the bill, we reviewed the key areas of lobbying activity and the compromises made in the final text. We focused on legislative provisions relating to management of the National Institutes of Health, incentives for medical product development, and approval standards for new drugs and devices. By the end of the first comment period, the Committee received 118 comments. Most respondents were patient organizations, professional societies, and pharmaceutical and device companies. Overall, the majority of public comments were positive, although public health and consumer organizations were underrepresented in the number of submitted comments. As the legislative process continued, the draft bill underwent several changes relating to NIH funding, market exclusivity provisions, and scrutiny of regulatory evidentiary standards. Understanding the key statutory provisions and how they have evolved could help patients, researchers, and advocates make more informed comments on the bill and future health care legislation.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue 2: Symposium – Covert Medication: Legal, Professional, and Ethical Considerations , Summer 2017 , pp. 212 - 220
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Gonsalves, G. and Zuckerman, D., “Commentary: Will 20th Century Patient Safeguards Be Reversed in the 21st Century?” BMJ 350 (2015): h1500.CrossRefGoogle Scholar
Walker, J. L., “The Origins and Maintenance of Interest Groups in America,” American Political Science Review 77, no. 2 (1983): 390-406; A. T. Denzau and J. C. Munger, “Legislators and Interest Groups: How Unorganized Interests Get Represented,” Americal Political Science Review 80, no. 1 (1986): 89-106.Google Scholar
Hojnacki, M. and Kimball, D. C., “The Who and How of Organizations' Lobbying Strategies in Committee,” Journal of Politics 61, no. 4 (1999): 999-1024; J. W. Yackee and S. W. Yackee, “A Bias toward Business? Assessing Interest Group Influence on the Bureaucracy,” Journal of Politics 68, no. 1 (2006): 128-139; S. D. Ansolabehere, M. de Figueiredo, and J. M. Snyder, “Why Is There So Little Money in U.S. Politics?” Journal of Economic Perspective 17, no. 1 (2003): 105-130; J. Milyo, D. Primo, and T. Groseclose, “Corporate PAC Campaign Contributions in Perspective,” Business & Politics 2, no. 1 (2000): 75-88; J. M. de Figueiredo and J. J. Kim, “When Do Firms Hire Lobbyists? The Organization of Lobbying at the Federal Communications Commission,” Ind. Corp. Change 13, no. 6 (2004): 883-900.Google Scholar
Baumgartner, F. R., Berry, J. M., Hojancaki, M., Kimball, D. C., Leech, B. L., Lobbying and Policy Change: Who Wins, Who Loses, and Why (Chicago: University of Chicago Press, 2009); S. R. Furlong and C. M. Kerwin, “Interest Group Participation in Rulemaking: A Decade of Change,” Journal of Public Administration Research and Theory 15, no. 3 (2005): 353-370.Google Scholar
Leech, B. A., Baumgartner, F. R., La Pira, T., and Semanko, N., “Drawing Lobbyists to Washington: Government Activity and the Demand for Advocacy,” Political Research Quarterly 58, no. 1 (2005): 19-30.Google Scholar
Vernick, J. S., “Lobbying and Advocacy for the Public's Health: What Are the Limits for Nonprofit Organizations?” American Journal of Public Health 89, no. 9 (1999): 1425-1429; B. C. Vladeck, “The Political Economy of Medicare,” Health Affairs (Millwood) 18, no. 1 (1999): 22-36; L. E. Tesler and R. E. Malone, “Corporate Philanthropy, Lobbying, and Public Health Policy,” American Journal of Public Health 98, no. 12 (2008): 2123-2133.CrossRefGoogle Scholar
Moffitt, S. L., “Promoting Agency Reputation through Public Advice: Advisory Committee Use in the FDA,” Journal of Politics 72, no. 3 (2010): 880-893.Google Scholar
Oliver, T. R., Lee, P. R., and Lipton, H. L., “A Political History of Medicare and Prescription Drug Coverage,” Milbank Quarterly 82, no. 2 (2004): 283-354.Google Scholar
Internal Revenue Service, “Tax Law Change to the Medical Device Excise Tax,” available at <http://www.irs.gov/uac/news-room/medical-device-excise-tax> (last visited June 20, 2017).+(last+visited+June+20,+2017).>Google Scholar
de Figueiredo, J. M. and Richter, B. K., “Advancing the Empirical Research on Lobbying,” Annual Review of Political Science 17 (2014): 163-185; N. Grasse and B. Heidbreder, “The Influence of Lobbying Activity in State Legislatures: Evidence from Wisconsin,” Legislative Studies Quarterly 36, no. 4 (2011): 567-589; B. K. Richter, K. Samphantharak, and J. F. Timmons, “Lobbying and Taxes,” American Journal of Political Science 53, no. 4 (2009): 893-909; T. Duso, “Lobbying and Regulation in a Political Economy: Evidence from the U.S. Cellular Industry,” Public Choice 122, nos. 3/4 (2005): 251-276.Google Scholar
See Baumgartner, et al., supra note 5.Google Scholar
Hwang, T. J., Avorn, J., Carpenter, D., and Kesselheim, A. S., “Quantifying the Food and Drug Administration's Rulemaking Delays Highlights the Need for Transparency,” Health Affairs (Millwood) 33, no. 2 (2014): 309-315.Google Scholar
Id.; Hwang, T. J., Avorn, J., and Kesselheim, A. S., “Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration,” Journal of Health Politics, Policy and Law 39, no. 4 (2014): 751-780.Google Scholar
Stevens, A. J., Jensen, J. J., Wyller, K., Kilgore, P. C., Chatterjee, S., and Rohrbaugh, M. L., “The Role of Public-Sector Research in the Discovery of Drugs and Vaccines,” New England Journal of Medicine 364, no. 6 (2011): 535-541; A. S. Kesselheim, Y. T. Tan, and J. Avorn, “The Roles of Academia, Rare Diseases, and Repurposing in the Development of the Most Transformative Drugs,” Health Affairs (Millwood) 34, no. 2 (2015): 286-293.Google Scholar
Gingrich, N., “Opinion: Double the N.I.H. Budget,” New York Times, April 22, 2015, available at <http://www.nytimes.com/2015/04/22/opinion/double-the-nih-budget.html> (last visited May 16, 2017).+(last+visited+May+16,+2017).>Google Scholar
Kesselheim, A. S., Avorn, J., and Sarpatwari, A., “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform,” JAMA 316, no. 8 (2016): 858-871.Google Scholar
Sibbald, B. and Roland, M., “Understanding Controlled Trials: Why Are Randomised Controlled Trials Important?” BMJ 316, no. 7126 (1998): 201.Google Scholar
Dhruva, S. S., Bero, L. A., and Redberg, R. F., “Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices,” JAMA 302, no. 24 (2009): 2679-2685; N. S. Downing, J. A. Aminawung, N. D. Shah, H. M. Krumholz, and J. S. Ross, “Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” JAMA 311, no. 4 (2014): 368-377; T. J. Hwang, J. H. Powers, D. Carpenter, and A. S. Kesselheim, “Accelerating Innovation in Rapid Diagnostics and Targeted Antibacterials,” Nature Biotechnology 33, no. 6 (2015): 589-590.Google Scholar
Redberg, R. F., “Faster Drug Approvals Are Not Always Better and Can Be Worse,” JAMA Internal Medicine 175, no. 8 (2015): 1398.Google Scholar
Floyd, J. S. and Psaty, B. M., “The Potential Risks of Expedited Approval of Drugs for Acute Bacterial Infections,” JAMA Internal Medicine 174, no. 9 (2014): 1436-1437.Google Scholar
Avorn, J. and Kesselheim, A. S., “The 21st Century Cures Act -Will It Take Us Back in Time?” New England Journal of Medicine 372, no. 26 (2015): 2473-2475.CrossRefGoogle Scholar
Gonsalves, G., Harrington, M., and Kessler, D. A., “Don't Weaken the FDA's Drug Approval Process,” New York Times, June 11, 2015, available at <http://www.nytimes.com/2015/06/11/opinion/dont-weaken-the-fdas-drug-approval-process.html> (last visited May 16, 2017); R. F. Redberg and S. S. Dhruva, “The FDA's Medical Device Problem,” New York Times, July 17, 2015, available at <http://www.nytimes.com/2015/07/17/opinion/the-fdas-medical-device-problem.html> (last visited May 16, 2017); Editorial Board, The New York Times. “How Not to Fix the FDA,” New York Times, July 20, 2015, available at <http://www.nytimes.com/2015/07/20/opinion/hownot-to-fix-the-fda.html> (last visited May 16, 2017); K. Jaggar, “Speeding Ineffective and Unsafe Treatments to Market in the Name of Patients? Not So Fast,” Huffington Post, July 13, 2016, available at <http://www.huffingtonpost.com/karuna-jaggar/speeding-ineffective-and-_b_7757946.html> (last visited May 16, 2017). (last visited May 16, 2017); R. F. Redberg and S. S. Dhruva, “The FDA's Medical Device Problem,” New York Times, July 17, 2015, available at (last visited May 16, 2017); Editorial Board, The New York Times. “How Not to Fix the FDA,” New York Times, July 20, 2015, available at (last visited May 16, 2017); K. Jaggar, “Speeding Ineffective and Unsafe Treatments to Market in the Name of Patients? Not So Fast,” Huffington Post, July 13, 2016, available at (last visited May 16, 2017).' href=https://scholar.google.com/scholar?q=Gonsalves,+G.,+Harrington,+M.,+and+Kessler,+D.+A.,+“Don't+Weaken+the+FDA's+Drug+Approval+Process,”+New+York+Times,+June+11,+2015,+available+at++(last+visited+May+16,+2017);+R.+F.+Redberg+and+S.+S.+Dhruva,+“The+FDA's+Medical+Device+Problem,”+New+York+Times,+July+17,+2015,+available+at++(last+visited+May+16,+2017);+Editorial+Board,+The+New+York+Times.+“How+Not+to+Fix+the+FDA,”+New+York+Times,+July+20,+2015,+available+at++(last+visited+May+16,+2017);+K.+Jaggar,+“Speeding+Ineffective+and+Unsafe+Treatments+to+Market+in+the+Name+of+Patients?+Not+So+Fast,”+Huffington+Post,+July+13,+2016,+available+at++(last+visited+May+16,+2017).>Google Scholar
Sachs, R. E., “The New Model of Interest Group Representation in Patent Law,” Yale Journal of Law and Technology 16, no. 2 (2014): 344-396; C. R. Sunstein, “Interest Groups in American Public Law,” Stanford Law Review 38, no. 1 (1985): 29-87.Google Scholar
Yackee, S. W., “The Politics of Ex Parte Lobbying: Pre-Proposal Agenda Building and Blocking during Agency Rulemaking,” Journal of Public Administration Research and Theory 22, no. 2 (2012): 373-393.CrossRefGoogle Scholar
Lazar, A., Center for Responsive Politics, “PhRMA Companies Push Hard on House Bill to Ease Testing of New Drugs,” available at <https://www.opensecrets.org/news/2015/06/phrma-companies-push-hard-on-house-bill-to-ease-testing-of-new-drugs/> (last visited May 16, 2017).+(last+visited+May+16,+2017).>Google Scholar