Hostname: page-component-7479d7b7d-rvbq7 Total loading time: 0 Render date: 2024-07-13T05:45:55.529Z Has data issue: false hasContentIssue false
  • English
  • Français

The 21st Century Cures Potpourri: Was It Worth the Price?

Published online by Cambridge University Press:  06 January 2021

Jerome P. Kassirer
Jerome P. Kassirer*
Affiliation:
Tufts University School of Medicine
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Articles
Information
American Journal of Law & Medicine , Volume 44 , Issue 2-3: Symposium - The 21st Century Cures Act: A Cure for the 21st Century? , May 2018 , pp. 157 - 160
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2018

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

1 21st Century Cures Act of 2016, Pub. L. No. 114-225, 130 Stat. 1033 (2016) (to be codified in scattered sections of 21, 34, 38, and 42 U.S.C.).

2 H.R. 34, 114th Cong. (2016) (enacted). The House of Representatives passed H.R. 34 on November 30, 2016, by an Aye-No vote of 392-26. Final Vote Results for Roll Call 592, Office of the Clerk, U.S. House of Representatives, http://clerk.house.gov/evs/2016/roll592.xml [https://perma.cc/7BG5-F8K7].

3 H.R. 34. The Senate passed H.R. 34 on December 7, 2016, by a Yea-Nay vote of 94-5. Roll Call Vote 114th Congress - 2nd Session, U.S. Senate, https://www.senate.gov/legislative/LIS/roll_call_lists/roll_call_vote_cfm.cfm?congress=114&session=2&vote=00157 [https://perma.cc/HH3H-5GRQ].

4 President Barack Obama signed the 21st Century Cures Act into law on December 13, 2016.

5 See Hudson, Kathy L. & Collins, Francis S., The 21st Century Cures Act – A View from the NIH, 376 New Eng. J. Med. 111 (2017)CrossRefGoogle ScholarPubMed.

6 Id. at 113.

7 Id. at 111.

8 Id. at 112-13.

9 See id.

10 Sydney Lupkin & Steven Findlay, Grab Bag of Goodies in 21st Century Cures Act, Kaiser Health News (Dec. 7, 2016), https://khn.org/news/grab-bag-of-goodies-in-21st-century-cures-act/ [https://perma.cc/U6VY-9J55].

11 See Kesselheim, Aaron S. & Jerry Avorn, New “21st Century Cures” Legislation: Speed and Ease vs Science, 317 JAMA 581, 581 (2017)CrossRefGoogle ScholarPubMed.

12 See id. at 581; see also Hudson & Collins, supra note 6.

13 See Lupin & Findlay, supra note 10.

14 See, e.g., Avorn, Jerry & Kesselheim, Aaron S., The 21st Century Cures Act – Will It Take Us Back in Time?, 372 New Eng. J. Med. 2473 (2015)CrossRefGoogle ScholarPubMed.

15 See generally Shobha Misra, Randomized Double Blind Placebo Control Studies, The “Gold Standard” in Intervention Based Studies, 33 Indian J. Sexually Transmitted Diseases & AIDS 131 (2012).

16 Behnood Bikdeli et al., Two Decades of Cardiovascular Trials with Primary Surrogate Endpoints: 1990-2011, J. Am. Heart Ass'n, Mar. 21, 2017, at 1.

17 See 21st Century Cures Act §§ 3001, 3011, 3012, 3022, 3031; see also Kesselheim & Avorn, supra note 11, at 581.

18 See Svensson, Staffan et al., Surrogate Outcomes in Clinical Trials: A Cautionary Tale, 173 JAMA Internal Med. 611 (2013)CrossRefGoogle ScholarPubMed; see also Kesselheim & Avorn, supra note 11, at 581-82.

19 Kesselheim & Avorn, supra note 11, at 581-82.

20 See generally 21 C.F.R. pts. 50, 56, 312, 314, and 600 (FDA regulations providing safeguards designed to ensure the safety of clinical testing and the safety of products following marketing approval, including requirements for informed consent and institutional review boards, the review of animal studies prior to initial human testing, the monitoring of adverse drug experiences through the requirements of Investigational New Drug safety reports, safety update reports during agency review of a marketing application, and post-marketing adverse reaction reporting).

21 See, e.g., 2017 Medical Device Recalls, FDA, https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm535289.htm [https://perma.cc/2QAK-W8K4] (last updated Jan. 2, 2018) (listing all of the medical devices approved by the FDA for use that were recalled in 2017 because the devices were defective and/or posed a risk to health). See generally Drug Recalls, FDA, https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm [https://perma.cc/ZR3W-YBGS] (last updated Feb. 12, 2018); Medical Device Recalls, FDA, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm [https://perma.cc/CW4K-Z3HJ] (last updated Feb. 12, 2018).

22 See generally Implementing the 21st Century Cures Act: An Update from FDA and NIH: Hearing Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 115th Cong. (2017) (testimony of Scott Gottlieb, Comm'r of Food and Drugs) (outlining the FDA's implementation of the 21st Century Cures Act).

23 See 21st Century Cures Act pmbl.

24 See Sheila Kaplan, Who Wins and Loses with the 21st Century Cures Act?, PBS (Dec. 6, 2016), https://www.pbs.org/newshour/health/wins-loses-21st-century-cures-act [https://perma.cc/XS8H-4Y33]; Lupkin & Findlay, supra note 10.

25 See Kaplan, supra note 24.

26 See Sydney Lupkin, Legislation that Would Shape FDA and NIH Triggers Lobbying Frenzy, NPR (Nov. 25, 2016), https://www.npr.org/sections/health-shots/2016/11/25/503176370/legislation-that-would-shape-fda-and-nih-triggers-lobbying-frenzy [https://perma.cc/JV6J-UA2Q]; see also Lupkin & Findlay, supra note 10.

27 See Jerome P. Kassirer, On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health xvi, 50-51 (2005).

28 Kesselheim & Avorn, supra note 11, at 581.

29 See Fin. Crisis Inquiry Comm'n, The Financial Crisis Inquiry Report: Final Report of the National Commission on the Causes of the Financial and Economic Crisis in the United States xvi, xviii, 255 (2011).

30 See generally Tracking Deregulation in the Trump Era, Brookings Inst., https://www.brookings.edu/interactives/tracking-deregulation-in-the-trump-era/ [https://perma.cc/6SMJR3Q5] (database listing the Trump Administration's deregulatory activity, including rules, guidance, and policy revocations).