Box 47 Nontraditional Clinical Testing Pathwaysfasttrack Clinical Testing And Fda Review

Subpart E establishes procedures to expedite the development, evaluation, and marketing of new therapies intended to treat people with life-threatening and severely-debilitating illnesses (e.g., cancer and AIDS), especially where no satisfactory alternatives exist. (Section 312, Federal Register, 21 October 1988)

Accelerated Development and Review Process is a highly specialized mechanism for speeding the development of drugs that promise significant benefit for serious or life-threatening illnesses for which no therapy exists. This process incorporates several novel elements aimed at making sure that rapid development and review is balanced by safeguards to protect both patients and the integrity of the regulatory process.

Accelerated development/review can be used under two special circumstances: when approval is based on evidence of the product's effect on a "surrogate endpoint," and when the FDA determines that safe use of a product depends on restricting its distribution or use. A surrogate endpoint is a laboratory finding or physical sign that may not be a direct measure of how a patient feels, functions, or survives, but is still considered likely to predict therapeutic benefit for the patient.

The fundamental element of this process is that the manufacturers must continue testing after approval to demonstrate that the drug indeed provides therapeutic benefit to the patient. If not, the FDA can withdraw the product from the market more easily than usual. (Federal Register, 15 April 1992)

Treatment Investigational New Drugs are used to make promising new drugs available to desperately ill patients as early in the drug development process as possible. During Phase II studies, investigational new drugs are made available to patients before general marketing begins. The treatment IND track also allow the FDA to collect additional data on the drug's safety and effectiveness. To date, more than 39 Treatment INDs have been approved, mainly for AIDS and cancer indications. (Federal Register, 22 May 1987)

Parallel Track is another mechanism that permits dispensing investigational drugs, particularly to AIDS patients that do not qualify to participate in controlled clinical trials of promising drug candidates. The parallel track policy was developed by the US Public Health Service in response to the AIDS epidemic. (Federal Register of 21 May 1990)

drug rests with the agency. On occasion the FDA chooses not to follow a panel's recommendations.

The decision of whether a given IND is reviewed by CBER or CDER is not clear-cut. The designation BLA or NDA really depends on which branch of the FDA's drug division is assigned review responsibilities. CDER reviews all NDAs, while CBER reviews all BLAs. In general, most small peptides and proteins such as insulin, peptide antibiotics, some antibodies, and antibody fragments, fall under the purview of CDER. CBER reviews new recombinant proteins of higher molecular weights such as interleukins, colony-stimulating factors, and some antibodies, as well as vaccines.

The philosophy of the FDA in reviewing BLAs and NDAs continues to evolve (see Box 4.8 for summary).The current position is reflected in the agency's statement, "No

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