Abstract
Medical countermeasures (MCMs) are products that may be used in the event of a potential public health emergency resulting from a terrorist attack or natural disaster involving a chemical, biological, radiological, or nuclear (CBRN) insult. MCMs can be used for the diagnosis, prevention, or treatment of conditions associated with these threats. There are three major classes of MCMs: (1) biologic products such as vaccines, blood products, and antibodies, (2) drug products such as antimicrobials or antivirals, and (3) medical devices including diagnostic tests and protective equipment. One or more of these products may be needed during a public health emergency.
Due to the nature of their potential use, MCMs come under the same regulatory purview as any other therapeutic agent or medical device. Successful navigation of the regulatory pathways used to authorize use is essential for making these products available to the public in a time of need. This chapter provides an understanding of the regulatory pathways involved and how they may be applied to MCMs. The chapter will focus on the regulatory system in the United States, with examples of similarities or differences with that of other countries provided when possible.
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References
Allio T. Product development under FDA’s Animal Rule: understanding FDA’s expectations and potential implications for traditional development programs. Ther Innov Regul Sci. 2016;50:660–70.
FDA. FDA medical countermeasures initiative (MCMi) program update fiscal year 2016. 2016. https://www.fda.gov/downloads/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/AboutMCMi/UCM546894.pdf. Accessed 04 Sept 2017.
Humeniuk R. Pediatric medical countermeasures: closing the gap. Paper presented at the 2015 Pediatric Acute Radiation Syndrome and Chemical Public Health Emergency Medical Countermeasures (MCM) Conference. National Institutes of Health, Rockville, Maryland, 10 June 2015.
FDA. Significant dates in U.S. Food and Drug Law History. 2014. https://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm. Accessed 04 Sept 2017.
FDA. Guidance for industry and other stakeholders “Emergency Use Authorization of Medical Products and Related Authorities”. 2017. https://www.fda.gov/downloads/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/UCM493627.pdf. Accessed 04 Sept 2017.
FDA Guidance Database. US FDA, Silver Spring. 2017. https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. Accessed 04 Sept 2017.
PAHPRA. US Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. Public Law No. 113-5; 2013.
FDA. Approval letter for radiogardase. 2003. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-626_Radiogardase_Approv.pdf. Accessed 04 Sept 2017.
EMEA. Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances. Pursuant to Article 14 (8) of Regulation (EC) NO 726/2004. 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004883.pdf. Accessed 04 Sept 2017.
Health Canada. Guidance document submission and information requirements for extraordinary use new drugs (EUNDs). 2014. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/eund-dnue-eng.pdf. Accessed 04 Sept 2017.
FDA. FDA guidance for industry and FDA staff qualification process for drug development tools. 2014. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf. Accessed 04 Sept 2017.
FDA. FDA guidance for industry product development under the Animal Rule. 2015. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf. Accessed 04 Sept 2017.
21st Century Cures Act of 2016. Public Law No. 114-255.
FDA. Animal Rule Information. 2017. https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391604.htm. Accessed 04 Sept 2017.
National Academies of Sciences, Engineering, and Medicine. Integrating clinical research into epidemic response: the Ebola experience. Washington, DC: The National Academies Press; 2017. https://doi.org/10.17226/24739.
FDA. FDA News Release – FDA approves first treatment for a form of Batten disease. 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm555613.htm. Accessed 04 Sept 2017.
Mishra P, Murray J, Birnkrant D. Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: scientific and regulatory approaches to clinical trial designs. Hepatology. 2015;62(4):1298–303.
Nace M. Breaking News: FDA approves Sarepta’s Exondys 51 (Eteplirsen) as first therapy for Duchenne MD. Muscular Dystrophy News Today. 2016. https://musculardystrophynews.com/2016/09/19/fda-approves-sarepta-exondys-51-eteplirsen-dmd-first-therapy. Accessed 04 Sept 2017.
FDA. About FDA webpage – what does it mean for FDA to “classify” a medical device? 2015. https://www.fda.gov/aboutfda/transparency/basics/ucm194438.htm. Accessed 04 Sept 2017.
FDA. 510(k) Submission methods. 2017. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm134034.htm. Accessed 04 Sept 2017.
Project BioShield Act of 2004. Public Law No. 108-276.
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Allio, T. (2019). Regulatory Pathways for Medical Products Used in Biodefense. In: Singh, S., Kuhn, J. (eds) Defense Against Biological Attacks. Springer, Cham. https://doi.org/10.1007/978-3-030-03053-7_14
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DOI: https://doi.org/10.1007/978-3-030-03053-7_14
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