WASHINGTON - The FDA's "reinvention" of cancer drug regulation, announced one year ago in a White House ceremony with President Clinton and top administration officials, has yielded discernable, but modest results, according to senior management of biotech companies that are developing cancer therapies. Their assessment is supported by top FDA officials, including Robert DeLap, director of the division of oncology drugs products (DODP) of the Center for Drug Evaluation and Research.

Although IND submissions increased last year over 1995 (see chart, A2), there is little hard data that either the agency or companies can point to as evidence of the initiative's impact. In the last year, FDA has granted accelerated approval for two cancer drugs whose applications predated the initiative: taxotere (docetaxel), approved in May 1996 for treatment of locally advanced or metastatic breast cancer in patients who have progressed or relapsed following doxorubicin therapy; and camptosar (irinotecan), approved in June 1996 for treatment with metastatic colorectal cancer in patients whose disease has progressed following standard chemotherapy.

In addition, other than accelerated approval, most of the provisions of the cancer initiative, including provisions related to supplemental indications, increased patient access to unapproved products and greater involvement of patients on advisory panels, have had little impact on biotech companies.

FDA report card