Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition 8
FDAAA requires FDA to bring at least one REMS with elements to assure safe use
(ETASU) each year for public discussion at FDA’s Drug Safety and Risk Management
Advisory Committee (see Figure 1-3). These meetings are intended to solicit the com-
mittee’s view on the particular REMS’ success in assuring the drug’s safe use, ensuring
the REMS is not unduly burdensome for patients who need the drug, and minimizing
the burden on the healthcare delivery system. Although there have been criticisms that
these meetings have not occurred annually (see Chapter 16), those that have occurred
have involved extensive and critical evaluation of the REMS.
References
1. Claycamp HG. Perspective on quality risk management of pharmaceutical quality. Drug Information
Journal. 2007 41:353–367.
2. The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety. 2008. FDA website.
https://www.fda.gov/downloads/safety/fdassentinelinitiative/ucm124701.pdf. Accessed 12 August 2018.
3. Guidance for Industry: Development and Use of Risk Minimization Action Plans. FDA website. www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071616.pdf.
Accessed 12 August 2018.
4. Ibid.
5. Ibid.
6. Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products
and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans. Federal
Register website. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2010_register&docid=-
fr29se10-3.pdf. Accessed 12 August 2018.
7. Adverse events in hospitals: National incidence among Medicare beneficiaries. Washington, DC. Office
of the Inspector General, US Department of Health and Human Services (2010). https://oig.hhs.gov/
oei/reports/oei-06-09-00090.pdf. Accessed 12 August 2018.
8. Ibid.
9. Ibid.
10. Institute of Medicine. To err is human: Building a safer health care system. Washington, DC: National
Academy of Sciences November 1999.
11. Bleich S. Medical Errors: Five Years After the IOM Report. The Commonwealth Fund Publication #830.
The Commonwealth Fund website. https://pdfs.semanticscholar.org/b132/d78f82d6a8f8f724069f6f-
be4bdb85181b2e.pdf. Accessed 12 August 2018.
12. Op cit 10.
13. Ibid.
14. Gawande A. Complications: A Surgeon’s Notes on an Imperfect Science. New York, NY: Henry Holt 2002.
15. Gawande A. Better: A Surgeon’s Notes on Performance. New York, NY: Henry Holt 2007.
16. Gawande A. The Checklist Manifesto: How to Get Things Right. New York, NY: Henry Holt 2009.
17. Sunstein CR. Worst-Case Scenarios. Cambridge, MA Harvard University Press 2007.
18. Ibid.
19. FDA approval letter to the manufacturer of Sabril, 21 August 2009. FDA website. https://www.access-
data.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020427. Accessed 31 August
2018.
20. ICH Guideline E2F: Note for Guidance on Development [of] Safety Update Reports. ICH website. http://
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2F/Step4/E2F_Step_4.
pdf. Accessed 12 August 2018.
21. Ibid.
22. Op cit 1.
23. Ibid.
24. Bayley R. Don’t be terrorized: You’re more likely to die of a car accident, drowning, fire, or murder.
Reason Magazine website. http://reason.com/archives/2006/08/11/dont-be-terrorized. Accessed 12
August 2018.
25. Op cit 1.
26. Ibid.
27. 21 U.S.C. 355-1 Risk Evaluation and Mitigation Strategies. GPO website. https://www.gpo.gov/fdsys/
search/pagedetails.action?collectionCode=USCODE&browsePath=Title+21%2FChapter+9%2F-
Subchapter+V%2FPart+A%2FSec.+355-1&granuleId=USCODE-2010-title21-chap9-subchapV-pa-
FDAAA requires FDA to bring at least one REMS with elements to assure safe use
(ETASU) each year for public discussion at FDA’s Drug Safety and Risk Management
Advisory Committee (see Figure 1-3). These meetings are intended to solicit the com-
mittee’s view on the particular REMS’ success in assuring the drug’s safe use, ensuring
the REMS is not unduly burdensome for patients who need the drug, and minimizing
the burden on the healthcare delivery system. Although there have been criticisms that
these meetings have not occurred annually (see Chapter 16), those that have occurred
have involved extensive and critical evaluation of the REMS.
References
1. Claycamp HG. Perspective on quality risk management of pharmaceutical quality. Drug Information
Journal. 2007 41:353–367.
2. The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety. 2008. FDA website.
https://www.fda.gov/downloads/safety/fdassentinelinitiative/ucm124701.pdf. Accessed 12 August 2018.
3. Guidance for Industry: Development and Use of Risk Minimization Action Plans. FDA website. www.fda.
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071616.pdf.
Accessed 12 August 2018.
4. Ibid.
5. Ibid.
6. Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products
and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans. Federal
Register website. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2010_register&docid=-
fr29se10-3.pdf. Accessed 12 August 2018.
7. Adverse events in hospitals: National incidence among Medicare beneficiaries. Washington, DC. Office
of the Inspector General, US Department of Health and Human Services (2010). https://oig.hhs.gov/
oei/reports/oei-06-09-00090.pdf. Accessed 12 August 2018.
8. Ibid.
9. Ibid.
10. Institute of Medicine. To err is human: Building a safer health care system. Washington, DC: National
Academy of Sciences November 1999.
11. Bleich S. Medical Errors: Five Years After the IOM Report. The Commonwealth Fund Publication #830.
The Commonwealth Fund website. https://pdfs.semanticscholar.org/b132/d78f82d6a8f8f724069f6f-
be4bdb85181b2e.pdf. Accessed 12 August 2018.
12. Op cit 10.
13. Ibid.
14. Gawande A. Complications: A Surgeon’s Notes on an Imperfect Science. New York, NY: Henry Holt 2002.
15. Gawande A. Better: A Surgeon’s Notes on Performance. New York, NY: Henry Holt 2007.
16. Gawande A. The Checklist Manifesto: How to Get Things Right. New York, NY: Henry Holt 2009.
17. Sunstein CR. Worst-Case Scenarios. Cambridge, MA Harvard University Press 2007.
18. Ibid.
19. FDA approval letter to the manufacturer of Sabril, 21 August 2009. FDA website. https://www.access-
data.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020427. Accessed 31 August
2018.
20. ICH Guideline E2F: Note for Guidance on Development [of] Safety Update Reports. ICH website. http://
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2F/Step4/E2F_Step_4.
pdf. Accessed 12 August 2018.
21. Ibid.
22. Op cit 1.
23. Ibid.
24. Bayley R. Don’t be terrorized: You’re more likely to die of a car accident, drowning, fire, or murder.
Reason Magazine website. http://reason.com/archives/2006/08/11/dont-be-terrorized. Accessed 12
August 2018.
25. Op cit 1.
26. Ibid.
27. 21 U.S.C. 355-1 Risk Evaluation and Mitigation Strategies. GPO website. https://www.gpo.gov/fdsys/
search/pagedetails.action?collectionCode=USCODE&browsePath=Title+21%2FChapter+9%2F-
Subchapter+V%2FPart+A%2FSec.+355-1&granuleId=USCODE-2010-title21-chap9-subchapV-pa-