DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20185163

An introspection of quality of novel drug approvals by United States Food and Drug Administration

Rekha Mehani, Ajay K. Shukla

Abstract


Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance patient care.

Methods: FDA novel drug approvals were analysed from calendar year (CY) 2012 to 2016 on the basis of three criteria i.e., impact, access and predictability. Impact measured on the basis of: percentage of novel drug approvals (a) first in class (b) for rare diseases. Access measured on the basis of: percentage of novel drug approvals (a) first cycle approval (b) approval in the U.S. before other countries and (c) percentage of priority reviews. Predictability measured by: the percentage of novel drug approvals that met the PDUFA goal dates for the application review.

Results: Total number of novel drugs approved from CY 2012 to 2016 was 176 (average 35 novel drugs/ year). Impact of novel drug approvals: 40% were first in class and 39% were for rare diseases. Access of novel drug approvals: 84% were first cycle approval, 60% were approval in US before other countries, 51% priority reviews among novel drug approvals. Predictability of novel drug approvals: 97% approvals able to meet PDUFA goal dates for application review.

Conclusions: Novel drug approvals during CY 2012-2016 had a high quality which is very much evident by their high impact, good access and high predictability.


Keywords


BLA, FDA, Novel drug approvals, NDA, NME

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References


What does FDA do?. 2018. Available at: https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm. Accessed 02 January 2018.

Speed Up Drug Approvals? FDA Already Did. ? 2017 Available at: https://www.nbcnews.com/health/health-news/speed-drug-approvals-fda-already-did-n715481. Accessed 02 January 2018.

Novel Drugs 2015 Summary. 2016. Available at: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm485053.pdf. Accessed 02 January 2018.

Innovation in the Biopharmaceutical Pipeline: A Multidimensional View. 2013. Available at: http://phrma-docs.phrma.org/sites/default/files/pdf/2013innovationinthebiopharmaceuticalpipeline-analysisgroupfinal.pdf. Accessed 02 January 2018.

Rare Diseases-A Report on orphan Drugs in the pipeline. 201. Available at: http://phrma-docs.phrma.org/sites/default/files/pdf/Rare_Diseases_2013.pdf. Accessed 02 January 2018.

Vahle JL, Hutto DL, Postema M. Drug Discovery and Preclinical Development. In: Golan DE, Armstrong EJ, Armstrong AW, eds. Principles of Pharmacology. 4th ed. Philadelphia: Wolters Kluwer Health; 2017:919-32.

Priority Review. 2018. Available at: https://www.fda.gov/forpatients/approvals/fast/ucm405405.htm. Accessed 08 January 2018.

New Drug Application (NDA). 2016. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Accessed 02 January 2018.

Drugs@FDA: FDA Approved Drug Products. 2018, Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed 02 January 2018

2016 Novel Drug Approvals. 2017. Available at: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM536693.pdf.

Search Orphan Drug Designations and Approvals. 2018. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm. Accessed 08 January 2018.

2013 Novel New Drugs Summary. 2014. Available at: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf. Accessed 08 January 2018.

Report: FDA Drug, Device Approval Times Improving. 2015. Available at: https://www.raps.org/news-articles/news-articles/2015/1/report-fda-drug,-device-approval-times-improving. Accessed 08 January 2018.

PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Accessed 08 January 2018.