ABSTRACT
The regulation of pharmaceuticals by the U.S. Food and Drug Administration (FDA) plays a crucial role in balancing the need for expedited drug approval, patient safety, and market accessibility. This paper examines the impact of FDA drug regulations on pharmaceutical innovation, assessing how regulatory frameworks influence the speed at which new drugs reach the market while ensuring public health protections. The study explores key regulatory pathways, including the Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations, which facilitate faster access to novel treatments. Findings indicate that while these expedited approval mechanisms have significantly reduced the time required for life-saving drugs to reach patients, concerns remain regarding the potential compromise of safety due to limited pre-market clinical data. Post-market surveillance and risk mitigation strategies are essential to address these concerns, highlighting the need for a balanced regulatory approach. Furthermore, the study evaluates how regulatory policies affect pharmaceutical investment, innovation incentives, and drug pricing, impacting both industry stakeholders and patient access. The analysis concludes that while the FDA’s regulatory framework has evolved to accommodate scientific advancements and urgent medical needs, continuous refinement is necessary to enhance drug safety without stifling innovation or limiting patient access. A dynamic regulatory model that integrates rigorous scientific evaluation with adaptive approval processes is essential to ensuring that public health priorities align with pharmaceutical advancements in a rapidly evolving healthcare landscape.
References
- [1] Corr, P. and Williams, D., 2009. The pathway from idea to regulatory approval: examples for drug development. Conflict of interest in medical research, education, and practice.
- [2] Darrow, J.J., Avorn, J. and Kesselheim, A.S., 2020. FDA approval and regulation of pharmaceuticals, 1983-2018. Jama, 323(2), pp.164-176.
- [3] Eifler, A.C. and Thaxton, C.S., 2011. Nanoparticle therapeutics: FDA approval, clinical trials, regulatory pathways, and case study. Biomedical Nanotechnology: Methods and Protocols, pp.325-338.
- [4] Franco, P., Jain, R., Rosenkrands-Lange, E., Hey, C. and Koban, M.U., 2023. Regulatory pathways supporting expedited drug development and approval in ICH member countries. Therapeutic Innovation & Regulatory Science, 57(3), pp.484-514. DOI: 10.2217/cer-2021-0184.
- [5] Harvey, B.E., 2022. NASH: regulatory considerations for clinical drug development and US FDA approval. Acta pharmacologica Sinica, 43(5), pp.1210-1214. DOI: 10.1038/s41401-021-00832-z.
- [6] Kaltenboeck, A., Mehlman, A. and Pearson, S.D., 2021. Potential policy reforms to strengthen the accelerated approval pathway. Journal of Comparative Effectiveness Research, 10(16), pp.1177-1186. DOI: 10.2217/cer-2021-0184.
- [7] Kepplinger, E.E., 2015. FDA’s expedited approval mechanisms for new drug products. Biotechnology law report, 34(1), pp.15-37.
- [8] Kesselheim, A.S. and Darrow, J.J., 2015. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes. Clinical Pharmacology & Therapeutics, 97(1), pp.29-36. DOI: 10.1002/cpt.1.
- [9] Kesselheim, A.S. and Darrow, J.J., 2015. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes. Clinical Pharmacology & Therapeutics, 97(1), pp.29-36.
- Khurana, G., Rohilla, A. and Deep, A., 2018. Drug development process and novel drugs approved by FDA for 2017-18. Applied Clinical Research, Clinical Trials and Regulatory Affairs, 5(2), pp.80-98. DOI: 10.2174/2213476X05666180604083001.
- Liberti, L., Bujar, M., Breckenridge, A., Hoekman, J., McAuslane, N., Stolk, P. and Leufkens, H., 2017. FDA facilitated regulatory pathways: visualizing their characteristics, development, and authorization timelines. Frontiers in pharmacology, 8, p.161.
- Lipsky, M.S. and Sharp, L.K., 2001. From idea to market: the drug approval process. The Journal of the American Board of Family Practice, 14(5), pp.362-367.
- Lynch, H.F. and Bateman-House, A., 2020. Facilitating both evidence and access: improving FDA’s accelerated approval and expanded access pathways. Journal of Law, Medicine & Ethics, 48(2), pp.365-372. DOI: 10.1177/1073110520935352.
- Michaeli, D.T., Michaeli, T., Albers, S., Boch, T. and Michaeli, J.C., 2024. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. The European Journal of Health Economics, 25(6), pp.979-997.
- Michaeli, D.T., Michaeli, T., Albers, S., Boch, T. and Michaeli, J.C., 2024. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. The European Journal of Health Economics, 25(6), pp.979-997.
- Moore, T.J. and Furberg, C.D., 2012. The safety risks of innovation: the FDA’s Expedited Drug Development Pathway. JAMA, 308(9), pp.869-870.
- Panico, E., 2022. Analyzing Factors Impacting Time to Full Approval of Innovative Drugs via an Accelerated Approval Pathway in the United States(Doctoral dissertation, Seton Hall University).
- Rubin, E.H. and Gilliland, D.G., 2012. Drug development and clinical trials—the path to an approved cancer drug. Nature reviews Clinical oncology, 9(4), pp.215-222. DOI: 1038/nrclinonc.2012.22.
- Woodcock, J. and Woosley, R., 2008. The FDA critical path initiative and its influence on new drug development. Rev. Med., 59(1), pp.1-12. DOI: 10.1146/annurev.med.59.090506.155819.
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