Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

doi:10.3390/diseases6010002

. 2017 Dec 22;6(1):2.

doi: 10.3390/diseases6010002.

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

Ryan D Rykhus¹, Zachary V Shepard², Alix Young³, Hadley Frisby⁴, Kailee A Calder⁵, Collin M Coon⁶, Justin A Falk⁷, Sydney R McAndrews⁸, Aspen Turner⁹, Christina Chang¹⁰, Johanna Michelsohn¹¹, Raegan Petch¹², Sarah M Dieker¹³, Benjamin H Markworth¹⁴, Kevin Alamo-Perez¹⁵, Aaron J Hosack¹⁶, Jacob M Berg¹⁷, Christian Schmidt¹⁸, Joachim Storsberg¹⁹, Mark A Brown^{20

21

22}

Affiliations

¹ School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA. ryanrykhus@gmail.com.
² Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. zshepard1216@gmail.com.
³ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. alixyoung17@gmail.com.
⁴ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. hfrisby@rams.colostate.edu.
⁵ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. kaileecalder@gmail.com.
⁶ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. Collin.m.coon@gmail.com.
⁷ Department of Mechanical Engineering, Colorado State University, Fort Collins, CO 80523, USA. Justin.falk98@gmail.com.
⁸ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. Sydney.r.mcandrews@gmail.com.
⁹ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. aeturner@rams.colostate.edu.
¹⁰ School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA. ctchang@rams.colostate.edu.
¹¹ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. jmiche@rams.colostate.edu.
¹² Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, CO 80523, USA. rpetch@rams.colostate.edu.
¹³ Walter Scott College of Engineering, Colorado State University, Fort Collins, CO 80523, USA. dieksar17@yahoo.com.
¹⁴ School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA. bmarkworth@comcast.net.
¹⁵ Department of Electrical and Computer Engineering, Colorado State University, Fort Collins, CO 80523, USA. kevalamop777@gmail.com.
¹⁶ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. ahosack2017@gmail.com.
¹⁷ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. jacob.berg@q.com.
¹⁸ Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany. Christian.schmidt@iap.fraunhofer.de.
¹⁹ Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany. joachim.storsberg@iap.fraunhofer.de.
²⁰ Department of Clinical Sciences, Colorado State University, Fort Collins, CO 80523, USA. Mark.Brown@colostate.edu.
²¹ Cell and Molecular Biology Program, Colorado State University, Fort Collins, CO 80523, USA. Mark.Brown@colostate.edu.
²² Epidemiology Section, Colorado School of Public Health, Fort Collins, CO 80523, USA. Mark.Brown@colostate.edu.

PMID: 29271878
PMCID: PMC5871948
DOI: 10.3390/diseases6010002

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

Ryan D Rykhus et al. Diseases. 2017.

. 2017 Dec 22;6(1):2.

doi: 10.3390/diseases6010002.

Authors

Affiliations

¹ School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA. ryanrykhus@gmail.com.
² Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. zshepard1216@gmail.com.
³ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. alixyoung17@gmail.com.
⁴ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. hfrisby@rams.colostate.edu.
⁵ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. kaileecalder@gmail.com.
⁶ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. Collin.m.coon@gmail.com.
⁷ Department of Mechanical Engineering, Colorado State University, Fort Collins, CO 80523, USA. Justin.falk98@gmail.com.
⁸ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. Sydney.r.mcandrews@gmail.com.
⁹ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. aeturner@rams.colostate.edu.
¹⁰ School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA. ctchang@rams.colostate.edu.
¹¹ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. jmiche@rams.colostate.edu.
¹² Department of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, CO 80523, USA. rpetch@rams.colostate.edu.
¹³ Walter Scott College of Engineering, Colorado State University, Fort Collins, CO 80523, USA. dieksar17@yahoo.com.
¹⁴ School of Biomedical Engineering, Colorado State University, Fort Collins, CO 80523, USA. bmarkworth@comcast.net.
¹⁵ Department of Electrical and Computer Engineering, Colorado State University, Fort Collins, CO 80523, USA. kevalamop777@gmail.com.
¹⁶ Department of Biology, Colorado State University, Fort Collins, CO 80523, USA. ahosack2017@gmail.com.
¹⁷ Department of Biomedical Sciences, Colorado State University, Fort Collins, CO 80523, USA. jacob.berg@q.com.
¹⁸ Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany. Christian.schmidt@iap.fraunhofer.de.
¹⁹ Department of Biomaterials and Healthcare, Fraunhofer-Institute for Applied Polymer Research (IAP), Division of Life Science and Bioprocesses, 14476 Potsdam-Golm, Germany. joachim.storsberg@iap.fraunhofer.de.
²⁰ Department of Clinical Sciences, Colorado State University, Fort Collins, CO 80523, USA. Mark.Brown@colostate.edu.
²¹ Cell and Molecular Biology Program, Colorado State University, Fort Collins, CO 80523, USA. Mark.Brown@colostate.edu.
²² Epidemiology Section, Colorado School of Public Health, Fort Collins, CO 80523, USA. Mark.Brown@colostate.edu.

PMID: 29271878
PMCID: PMC5871948
DOI: 10.3390/diseases6010002

Abstract

Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation's sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics.

Keywords: FDA; commercial drug approval; privatization; windfall tax.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

**Figure 1**
FDA center for drug evaluation and research median times (expressed in months) for approval since the year 1994.

See this image and copyright information in PMC

References

1. Brown M.A. The Evolution of Pediatric Disease—A Moving Target in Public Health. Diseases. 2017;5:18. doi: 10.3390/diseases5030018. - DOI - PMC - PubMed
1. Kriz B., Fabianova K., Maixnerova M., Benes C., Maly M. Pertussis: A reemerging infection? Epidemiol. Mikrobiol. Imunol. Cas. Spol. Epidemiol. Mikrobiol. Ceske Lek. Spol. JE Purkyne. 2007;56:51–65. - PubMed
1. Moss W.J. Measels. Lancet. 2017 doi: 10.1016/S0140-6736(17)31463-0. - DOI - PubMed
1. Naghavi M., Abajobir A.A., Abbafati C., Abbas K.M., Abd-Allah F., Abera S.F. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: A systematic analysis for the Global Burden of Disease Study. Lancet. 2017;390:1151–1210. doi: 10.1016/S0140-6736(17)32152-9. - DOI - PMC - PubMed
1. National Cancer Institute: Childhood Cancers. [(accessed on 4 November 2017)]; Available online: https://www.cancer.gov/types/childhood-cancers.

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[1] Brown M.A. The Evolution of Pediatric Disease—A Moving Target in Public Health. Diseases. 2017;5:18. doi: 10.3390/diseases5030018. - DOI - PMC - PubMed

[2] Brown M.A. The Evolution of Pediatric Disease—A Moving Target in Public Health. Diseases. 2017;5:18. doi: 10.3390/diseases5030018. - DOI - PMC - PubMed

[3] Kriz B., Fabianova K., Maixnerova M., Benes C., Maly M. Pertussis: A reemerging infection? Epidemiol. Mikrobiol. Imunol. Cas. Spol. Epidemiol. Mikrobiol. Ceske Lek. Spol. JE Purkyne. 2007;56:51–65. - PubMed

[4] Kriz B., Fabianova K., Maixnerova M., Benes C., Maly M. Pertussis: A reemerging infection? Epidemiol. Mikrobiol. Imunol. Cas. Spol. Epidemiol. Mikrobiol. Ceske Lek. Spol. JE Purkyne. 2007;56:51–65. - PubMed

[5] Moss W.J. Measels. Lancet. 2017 doi: 10.1016/S0140-6736(17)31463-0. - DOI - PubMed

[6] Moss W.J. Measels. Lancet. 2017 doi: 10.1016/S0140-6736(17)31463-0. - DOI - PubMed

[7] Naghavi M., Abajobir A.A., Abbafati C., Abbas K.M., Abd-Allah F., Abera S.F. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: A systematic analysis for the Global Burden of Disease Study. Lancet. 2017;390:1151–1210. doi: 10.1016/S0140-6736(17)32152-9. - DOI - PMC - PubMed

[8] Naghavi M., Abajobir A.A., Abbafati C., Abbas K.M., Abd-Allah F., Abera S.F. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: A systematic analysis for the Global Burden of Disease Study. Lancet. 2017;390:1151–1210. doi: 10.1016/S0140-6736(17)32152-9. - DOI - PMC - PubMed

[9] National Cancer Institute: Childhood Cancers. [(accessed on 4 November 2017)]; Available online: https://www.cancer.gov/types/childhood-cancers.

[10] National Cancer Institute: Childhood Cancers. [(accessed on 4 November 2017)]; Available online: https://www.cancer.gov/types/childhood-cancers.

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Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

Affiliations

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

Authors

Affiliations

Abstract

Conflict of interest statement

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