WASHINGTON - When President Clinton and FDA Commissioner David Kessler announced the "reinvention of cancer regulation" in late March, biotech companies adopted a "wait-and-see" stance (see BioCentury April 1). Six months later, senior managers of biotech companies with cancer therapies in the pipeline report that significant progress has been made in streamlining the approvals process and that the agency has followed through on its commitments. But they note it is still too early to assess the overall impact of the initiatives.

The reforms include accelerated approval of drugs based on demonstrated tumor shrinkage, expedited availability of drugs approved in certain other nations, and removal of obstacles to certain non-commercial INDs.

The jury is still out on the overall scope of the reforms; and their most significant impacts on patients and manufacturers may not be felt for another year. Most important, it is still too early to judge how deeply the changes embodied in Kessler's pledges, made under the now-dissipated threat of congressional reform legislation, have permeated into the FDA bureaucracy.

Agency report card

To asssess the agency's performance to date, BioCentury spoke with two FDA officials with responsibility for implementing the policies, Michael Friedman, deputy commissioner for operations, and Robert DeLap, recently appointed director of the oncology drugs products division of the Center for Drug Evaluation and Review. They reiterated the agency's commitments to speed patient access to cancer therapies and to work with sponsors to get drugs approved as rapidly as possible.