Process and Regulations of Fast Track
New pharmacological agents go a long way in clinical trials and approvals from the Food and Drug Administration before entering a wide market and becoming available to needy patients in the United States. At the same time, for promising drugs that can significantly improve the results of existing therapy or fill a missing niche, this process can be accelerated using the Fast Track protocol (Woo & Robinson, 2015). The latter provides for the filing of a special application by a pharmacological company at the FDA office, which the latter examine within 60 days. If the medicine acquires Fast Track status, manufacturers receive a number of concessions, such as the right to more frequent correspondence and meetings with representatives of this state regulatory body and the possibility of cooperation in conducting a clinical trial. If convincing positive results are obtained, it is possible to obtain FDA approval after a single phase 2 clinical trial (Papadimitriou & Butler, 2017). In addition, the verification process of such a pharmacological agent is significantly reduced from 10 to 6 months.
In order to be able to obtain faster approval via the Fast Track protocol, the drug agent must meet a number of requirements. Specific medical conditions are not indicated, but it is prescribed that the effect of the drug should be aimed at treating a life-threatening or dangerous disease, such as heart failure (Papadimitriou & Butler, 2017). A prerequisite is either to improve the outcome of existing treatment, such as a reduction in mortality or disability, or a significant reduction in the toxicity of therapy (Woo & Robinson, 2015). In addition, medical conditions that do not have developed a pharmacological treatment, such as some rare and orphan diseases, are also eligible for faster approval from the FDA via the Fast Track protocol. Therefore, due to this possibility, patients will more quickly gain access to the most modern therapy and increase the chances of a more favorable outcome of treatment.
Papadimitriou, L., & Butler, J. (2017). “Fast Track” Development and Approval Process for Heart Failure Therapeutics. Clinical Pharmacology & Therapeutics, 102(2), 184-186.
Woo, T. M., & Robinson, M. V. (2015). Pharmacotherapeutics for advanced practice nurse prescribers. FA Davis.
The FDA made it possible for critically needed medications to be introduced to the US market promptly using the “Fast Track” procedure. “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need (Vaggelas & Seimetz, 2019). With fast track, FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met (Vaggelas & Seimetz, 2019). To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use (Darrow, Avorn, & Kesselheim, 2018).
The medical conditions that warrant “Fast Track” drugs are serious or life-threatening conditions and those conditions that result in unmet medical needs (Darrow et al., 2018). Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. Stroke, epilepsy, brain disorders, depression, AIDS, Alzheimer’s, heart failure, diabetes, and cancer are examples of serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy (Darrow et al., 2018).
Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2018). The FDA breakthrough-drug designation-four years of experience. N Engl J Med, 378(15), 1444-1453.
Vaggelas, A., & Seimetz, D. (2019). Expediting drug development: FDA’s new regenerative medicine advanced therapy designation. Therapeutic Innovation & Regulatory Science, 53(3), 364-373. doi: 10.1177/2168479018779373