Fast Track

Fast Track

Fast track involves a process that facilitates the development and expedites the review of drugs that will fill unmet medical needs or treat serious medical conditions. The process is designed to enable patients to access critical new medications for their conditions earlier (Martin & Shenfield, 2016). The drug has to either provide therapy in treating a condition that has no existing therapy or provide a therapy that is more effective than the available therapies.

In case available therapies are treating the condition at hand, the fast track drug has to show some superiority over the existing therapies. Dubey, Kotian, & Shriram (2019) contend that the new drug would have superior effectiveness in treating the conditions by showing more desirable outcomes and avoid serious side effects that may be associated with the available therapies. The new drug would also improve the diagnosis of a serious condition that earlier therapies failed, reduce significant clinical toxicity related to available therapies, or address anticipated public health needs.

For a drug to be fast-tracked, the company producing the drug must request a Fast Track from the U.S. Food and Drug Administration. The company would do this at any stage of drug development. In turn, the FDA will review the request and decide whether the drug meets the unmet medical need for serious conditions within sixty days (Ronaldson-Bouchard & Vunjak-Novakovic, 2018).

Medical Conditions warrant the use of “Fast Track” drugs

The conditions that warrant the use of “Fast Track” drugs include cancer, heart failure, Alzheimer’s, diabetes, epilepsy, depression, and AIDS. These diseases are considered to be serious health conditions. Some of these conditions do not have therapies in place, while others have existing therapies that are not very effective. In case any drug manufacturing company requests FDA to Fast Track their drugs for these conditions, the FDA is likely to approve their requests.

References

Dubey, A., Kotian, B., & Shriram, R. G. (2019). New Drugs and Clinical Trials Rules, 2019: Towards Fast-track Accessibility of New Drugs to the Indian Population. Indian Journal of Pharmaceutical Education and Research, 53(4), S451-S459.

Martin, J., & Shenfield, G. (2016). The hazards of rapid approval of new drugs. Australian prescriber, 39(1), 2.

Ronaldson-Bouchard, K., & Vunjak-Novakovic, G. (2018). Organs-on-a-chip: a fast track for engineered human tissues in drug development. Cell stem cell, 22(3), 310-324.