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THE PHARMA REVIEW (MARCH 2009)

USFDA Accelerated Approval Mechanism - An Overview

Prashant B. Musmade, Manthan D.Janodia, D.Sreedhar, Virendra S. Ligade, N.Udupa

Abstract: In the process to extend the benefit to terminally ill patients, FDA has established the review process called as Accelerated Approval (AA) mechanism. This mechanism particularly aims to speed up the approval process for promising drugs that offer therapeutic advantage over the existing therapy particularly for serious and life threatening illnesses. The aim of FDA is to provide the patients with the advantages of the newer therapies; it does not always result to be a promising outcome. Many pharmaceutical companies have flouted FDA rules of continuing the post marketing surveillance studies after the grant of Accelerated Approval, and most of these companies have not submitted the post marketing surveillance report to FDA. This paper tries to identify the lacunae in this process of FDA of Accelerated Approval.

What is Accelerated Approval?
FDA has long been criticized for its delay in approval process. This has lead FDA to take steps to expedite the approval process so that drugs are available to the terminally ill patients well in time. Accelerated Approval is a highly specialized mechanism to speed up the approval of drugs or biologics that promise significant benefit over existing therapy for serious or life-threatening illnesses. Accelerated approval is the short-hand term for the process by which the FDA quickly conducts its evaluation of new treatment applications while also putting new safeguards in place.

How Accelerated Approval is granted?
Accelerated review, established by 1991 regulations, can be used in two very special circumstances: when approval is based on evidence of the product's effect on a "surrogate endpoint," and when FDA determines that safe use of a product depends on restricting its distribution or use. In 1992, subpart H was added to NDA regulation to allow accelerated approval for diseases that are serious or life threatening where the new drug appears to provide benefit over the available therapy. A "surrogate endpoint" is a laboratory finding or physical sign that may not, in itself, be a direct measurement of how a patient feels, functions or survives, but nevertheless is considered likely to predict therapeutic benefit. For example, high blood pressure and elevated serum cholesterol are risk factors for heart and blood vessel disease. Drugs that control blood pressure or cholesterol can reasonably be expected to help control or prevent direct signs of disease, such as angina, congestive heart failure after a heart attack, paralysis following a stroke, and sudden death.

 

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