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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