Skip to main content
SpringerLink
Log in

Risk Evaluation and Mitigation Strategies With Elements to Assure Safe Use: Alignment of the Goals With the Tools to Manage Risk

  • Product Safety
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require drug sponsors to submit a risk evaluation and mitigation strategies (REMS) program for those medicines with serious risks such that failure to effectively manage these risks would tip the benefit-risk balance. As of August 8, 2013, the 34 distinct individual and shared REMS programs that have specific elements to assure safe use (ETASU) were reviewed to ascertain the types of risks managed, the goals of the REMS, and the tools that were employed targeting prescribers, health care facilities, pharmacists, and particular conditions for safe use. Most REMS (65%) have a combination of risk mitigation and educational goals, but 4 REMS programs (12%) have exclusively educational goals. Preventing fetotoxicity (25%) is the most common risk managed by REMS with ETASU. Seventy-nine percent of ETASU REMS employ prescriber-based tools that include performing laboratory testing (eg, pregnancy, hepatic enzymes) or monitoring (eg, ophthalmologic examinations, documenting vaccination). The goals of REMS programs should focus on measurable behaviors that directly reduce risk. The tools that are employed should create the appropriate conditions for safe use. With the number of programs and the plethora of tools applied, serious consideration should be given to better integration of risk management into health care and pharmacy systems that are best equipped to manage such risks.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Food and Drug Administration Amendments Act of 2007. Pub L No. 110-85. September 27, 2007. United States Statutes at Large. 2007;121:823–978.

    Google Scholar 

  2. FDA. Guidance for industry: format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications-draft guidance. http://www.fda.gov/downloads/Drugs/Guidances/UCM184128.pdf. Published September 2009. Accessed November 26, 2013.

  3. FDA. A brief overview of risk evaluation & mitigation strategies (REMS). http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf. Accessed November 26, 2013.

  4. Choe LY. Risk evaluation and mitigation strategies (REMS). http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/UCM276838.pdf. Accessed November 26, 2013.

  5. Tabor E. Risk Evaluation and Mitigation Strategies for US Drug Development. Rockville, MD: Regulatory Affairs Professional Society; 2012.

    Google Scholar 

  6. 21 CFR. §314.500: Subpart H: accelerated approval of new drugs for serious or life-threatening illnesses. 2012.

  7. 21 CFR. §314.520: Approval with restrictions to assure safe use. 2012.

  8. FDA. Managing the risks from medical product use: creating a risk management framework. http://www.fda.gov/downloads/Safety/SafetyofSpecificProducts/UCM180520.pdf. Published May 1999. Accessed March 4, 2014.

  9. FDA. Guidance for industry: development and use of risk minimization action plans, guidance. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071616.pdf. Published March 2005. Accessed November 26, 2013.

  10. Toigo T. FDA public meeting standardizing and evaluating risk evaluation and mitigation strategies (REMS). http://www.fda.gov/downloads/Drugs/NewsEvents/UCM307704.pdf. Published July 25, 2013. Accessed March 4, 2014.

  11. FDA. Current number of approved and released REMS. http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm. Accessed August 23, 2013.

  12. Risk evaluation and mitigation strategies; notice of public meeting; reopening of comment period. Fed Regist. 2010;75:34453–34456. http://www.gpo.gov/fdsys/pkg/FR-2010-06-17/html/2010-14547.htm. Accessed November 26, 2013.

  13. Tufts Center for the Study of Drug Development. US healthcare stakeholders uncertain about benefits of risk evaluation program. http://csdd.tufts.edu/news/complete_story/pr_ir_jan-feb_2011. Published January 12, 2011. Accessed November 26, 2013.

  14. Frame JN, Jacobson JO, Vogel WH, et al. Assessment of risk evaluation and mitigation strategies in oncology: summary of the oncology risk evaluation and mitigation strategies workshop. J Oncol Pract. 2013;9(2):e24–e39.

    Article  Google Scholar 

  15. Office of the Inspector General. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety. https://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf. Published February 2013. Accessed November 26, 2013.

  16. FDA. PDUFA reauthorization performance goals and procedures fiscal years 2013 through 2017. http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf. Accessed November 26, 2013.

  17. FDA. Risk evaluation and mitigation strategy (REMS): the iPLEDGE Program. Single shared system for isotretinoin. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM234639.pdf. Initially approved October 2010. Most recently modified April 2012. Accessed March 4, 2014.

  18. FDA. Epogen/Procrit (Epoetin Alfa): risk evaluation and mitigation strategy (REMS). http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM200105.pdf. Initially approved February 2010. Most recently modified December 2013. Accessed March 4, 2014.

  19. FDA. Standardizing and evaluating risk evaluation and mitigation strategies (REMS): Thursday, July 25, 2013. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM364896.pdf. Accessed March 4, 2014.

  20. FDA. Standardizing and evaluating risk evaluation and mitigation strategies (REMS): Friday, July 26, 2013. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM364897.pdf. Accessed March 4, 2014.

  21. Regulations.gov. Standardizing and evaluating risk evaluation and mitigation strategies; notice of public meeting; request for comments. http://www.regulations.gov/#!docketDetail;=FDA-2013-N-0502. Accessed March 4, 2014.

Download references

Author information

Authors and Affiliations

  1. St. Johns University, New York, NY, USA

    Michael Cronin BA

  2. Amgen, 601 13th St, NW, Homer Bldg, 12th floor, Washington, DC, 20005, USA

    Susan Berger PhD & Paul J. Seligman MD, MPH

Authors
  1. Michael Cronin BA
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Susan Berger PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Paul J. Seligman MD, MPH
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Paul J. Seligman MD, MPH.

Additional information

Michael Cronin, formerly an intern at Amgen, is now pursuing a graduate degree at St. John’s University

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Cronin, M., Berger, S. & Seligman, P.J. Risk Evaluation and Mitigation Strategies With Elements to Assure Safe Use: Alignment of the Goals With the Tools to Manage Risk. Ther Innov Regul Sci 48, 724–733 (2014). https://doi.org/10.1177/2168479014527749

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/2168479014527749

Keywords

Search

Navigation