Approval of new drugs by the Food and Drug Administration (FDA) is an essential step of drug development in the United States. The goal of the FDA is to ensure that the new drug is safe for patients and efficient in treating their condition. However, in some instances, the FDA allows for a fast-track approval of new medicines. The present paper will seek to outline the cases where fast-track approval applies and outline the four phases of clinical trials required for regular FDA approval.
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Fast Track Approval
The fast track approval process can benefit patients by providing them with early access to effective drugs. According to Kesselheim, Wang, Franklin, and Darrow (2015), a fast track designation changes the nature of evidence required for approval, allowing the drugs to receive approval after a single phase 2 study. However, this opportunity is only available in specific instances. As stated by the FDA (2018), “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” (para. 1). A fast-track status is assigned to a new drug in the development phase and is based on two indicators: potential efficiency and the seriousness of the target condition.
Firstly, a drug that is accepted for a fast-track approval must address a serious condition. Kesselheim et al. (2015) state that fast track applies to life-threatening or severely debilitating diseases. Such conditions may include stroke, Alzheimer’s disease, diabetes, epilepsy, heart failure, and depression. Thus, in instances where the fast track status applies, the target condition poses a threat to the patient’s life. Secondly, a fast track status is assigned to medications that fill an unmet medical need. Jae (2014) explains that “An unmet medical need can exist both where there is no available therapy and where there is an available therapy, but the new drug would influence an unaddressed outcome or offer an improvement in areas like efficacy, toxicity, or safety” (p. 188). Thus, in instances where a fast track status is granted, the new drugs either have no existing alternatives or present significant advantages compared to existing alternatives.
FDA Approval Process
To achieve FDA approval, it is critical for the new drug to be proven successful in all four phases of clinical trials. The first phase of clinical trials tests the safety of the new drug on a group of 20 to 80 healthy volunteers (FDA, 2015). This stage aims to establish possible side effects and evaluate whether they are significant. During phase 2, the new drug is tested on 50 to 300 patients who are diagnosed with the target condition (FDA, 2015). The goal of this stage is to determine the effectiveness of the new drug, as well as the incidence of side effects. Phase 2 has the lowest success rate among the four stages of clinical trials, which is because most drugs fail to prove their effectiveness in controlled settings (Hay, Thomas, Craighead, Economides, & Rosenthal, 2014). Alternatively, drugs rejected during this phase might have a lot of side effects, thus adversely affecting patients’ health.
Drugs that successfully finish phase 2 trials enter phase 3. Here, clinical trials involve between 300 and 3000 patients and are designed to test different dosages, interactions with other drugs, and the frequency of specific side effects (FDA, 2015). Drugs that pass phase 3 trials successfully are approved by the FDA to enter the market. Phase 4 occurs when the new drug is already on the market. During this stage, the FDA monitors the use of the drug to identify unexpected adverse effects or safety issues that were not evident during the previous phases of clinical trials.
The FDA process for approving new drugs is extensive, which helps to ensure that the drugs available on the market are effective and safe for patients. However, in some instances, the potential benefits of a new drug outweigh the risks associated with it. Fast track approval is an effective way of expediting the delivery of new medicines to patients without compromising their safety.
Food and Drug Administration (FDA). (2018). Fast track. Web.
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Food and Drug Administration (FDA). (2015). FDA’s drug review process: Continued. Web.
Hay, M., Thomas, D. W., Craighead, J. L., Economides, C., & Rosenthal, J. (2014). Clinical development success rates for investigational drugs. Nature Biotechnology, 32(1), 40-51.
Jae, V. S. (2014). Simplifying FDASIA: The fast track to expedited drug approval efficiency. Administrative Law Review, 66(1), 173-198
Kesselheim, A. S., Wang, B., Franklin, J. M., & Darrow, J. J. (2015). Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: Cohort study. BMJ, 351(h4633), 1-7.