FDA Fast Track Development Program

Regulation of therapeutic goods in the United States

Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption
Government agencies Department of Health and Human Services -Food and Drug Administration- Department of Justice -Drug Enforcement Administration-
Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs
Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports

The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration (FDA) that accelerates the approval of investigational new drugs undergoing clinical trials with the goal review time of 60 days. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Determining whether a disease 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 disease, if left untreated, will progress from a less severe condition to a more serious one.

Any drug being developed as a treatment or preventative measure for a disease that does not have a current therapy is labelled as an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

Showing superior effectiveness
Avoiding serious side effects of an available treatment
Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
Decreasing a clinically significant toxicity of an accepted treatment

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
Eligibility for FDA Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious disease.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

Statistics

According to data on FDA website, Fast Track has generated the following workload from March 1998 to September 2011: Submitted 248 applications

Reviewed within 60 days:

Granted - 152
Denied - 87
Currently pending - 2

Reviewed for longer than 60 days:

Granted - 4
Denied - 1
Currently pending - 7

References

Reichert JM, Rochon SL, Zhang BD.A decade of the Fast Track programme. Nat Rev Drug Discov. 2008 Nov;7(11):885-6. Epub 2008 Oct 24 PMID 18948998
FDA website