Fast Track Process Designation by the FDA

Fast Track is a privileged designation of an investigational drug where the FDA quickly reviews the drug development and request for authorization, deciding within sixty days. Typically, drug review and approval during the development process take many months to even years (FDA, 2020). Moreover, the mother company developing the drug has to complete its development process and research before it can file for FDA approval. Under the Fast Track status, the drug is prioritized such that its approval takes a shorter time, and the company can submit each bit of research or development every time it is completed (Darrow, Avorn, & Kesselheim, 2020). The status also entails enhanced communication between the FDA and the company, to deliberate aby concerns promptly. The status can be applied at any stage in the drug development process. Fast Track helps to make new drugs that are urgently needed available in the markets as rapidly as possible.

Medical conditions warrant the use of “Fast Track” drugs.

Fast Track process is only available for drugs whose need in the healthcare industry is urgent. It is designated for those drugs that show optimism towards treating serious or life-threatening diseases (FDA, 2020). It is also available to drugs that promise to address an unmet medical need. Serious medical conditions-addressing drugs are judged according to how the drug impacts issues such as human survival, normal day-fay functioning, and the potential of the disease to progress to severity if left untreated (FDA, 2020). A good example is Hydroxychloroquine, which has been under review for the treatment of the current global Corona Virus pandemic. It is upon the center for Drug Evaluation and Research to receive the application and grant or deny the request. Notably, not every drug that is given the Fast Track priority gets approved for routine use, as patient safety comes first.

References

Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2020). FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA, 323(2), 164-176.

Food and Drug Administration (2020). About FDA. Fast Track Approvals: NDA and BLA Approvals. https://www.fda.gov/drugs/nda-and-bla-approvals/fast-track-approvals