Review of the Food and Drug Administration's Processing of a New Drug Application for Therafectin

EXECUTIVE SUMMARY:

In September 1993 the Food and Drug Administration (FDA) informed Greenwich Pharmaceuticals, Inc. (Greenwich) that its new drug application (NDA) for a new drug (Therafectin) to treat rheumatoid arthritis could not be approved because there was not adequate data demonstrating the drug's effectiveness. Subsequently, Congressman John D. Dingle requested that the OIG review Greenwich's concerns that the FDA did not follow applicable administrative procedures in reviewing the drug application. We found that, in general, the FDA did properly process the Therafectin NDA. We noted certain administrative shortcomings, but found no evidence that they affected the approval status of the NDA. In the final analysis, Greenwich was not able to adequately demonstrate--either to the FDA or an Arthritis Advisory Committee--that Therafectin was effective for the treatment of rheumatoid arthritis. As a result of this matter the FDA is instituting administrative improvements to strengthen the NDA review process.

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