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Date: Friday, March 29, 1996
FOR IMMEDIATE RELEASE
Contact: FDA Press Office(301)443-1130

CLINTON ADMINISTRATION ANNOUNCES PLAN TO SPEED DEVELOPMENT AND APPROVAL OF CANCER DRUGS

President Clinton today announced a major initiative to make promising new cancer therapies available sooner to American cancer patients. As part of Vice President Gore's National Performance Review, the Food and Drug Administration's "Reinventing the Regulation of Cancer Drugs" proposes to shorten development and review times for cancer products and to make it easier for many cancer drugs approved elsewhere to be made available to cancer patients in the U.S.

"Under the leadership of President Clinton, FDA is adopting a common sense approach to approving promising new cancer therapies," said Vice President Gore, who has been working on regulatory reform as part of the National Performance Review's effort to make the federal government work better and cost less. "The FDA is eliminating unnecessary and burdensome regulations while still maintaining critical public health protections. The result is safe, new cancer drug therapies that will be available to the American people in record time."

"Cancer is a terrible tragedy for many families in this country. With our actions today, we give them new hope," said HHS Secretary Donna E. Shalala, who joined the President at the White House event. "These measures will bring safe and effective therapies to cancer patients sooner."

"Our experience with accelerated approval, particularly for AIDS, leads us to believe that these initiatives may serve as a powerful stimulus to the development of new drugs to treat cancer," said FDA Commissioner David A. Kessler, M.D.

Joining the President, Vice President and Secretary Shalala at the announcement was Stacey Oller, a cancer survivor who wants to be an oral surgeon.

This cancer initiative represents another element of the Clinton Administration's efforts to streamline the regulatory process while maintaining high standards that protect patients. It was developed on the basis of suggestions and advice offered by cancer patients and their advocacy groups, representatives of the pharmaceutical industry, physicians and cancer researchers.

The initiative consists of four major proposals:

1. Accelerated Approval for Cancer Drugs. Although FDA now measures review times for cancer drugs in months, it can take years of testing before an application to market a cancer drug even reaches FDA. To speed the availability of cancer drugs, FDA may now rely on partial response (such as measurable but incomplete shrinkage of a tumor) to a therapy, in addition to the current criteria such as a patient's survival and improved quality of life. By basing accelerated approval on surrogate markers such as tumor shrinkage, and by allowing more definitive data on survival or other criteria to be developed after marketing approval, FDA believes that many cancer therapies will reach patients sooner.
2. Expanded Access for Drugs Approved Elsewhere. For patients with serious and life- threatening illnesses such as cancer, FDA has devised several programs that provide access to promising but unapproved therapies even as they are being studied. To make even more cancer drugs available before formal approval, FDA will encourage sponsors of experimental drugs that have been approved in certain other countries to apply for permission to distribute the drug to eligible cancer patients before final drug approval has been granted.
3. Increased Cancer Patient Representation at FDA Advisory Committee Meetings. FDA relies on advisory committees to provide outside expertise on agency policy and product decisions. Each advisory committee typically includes one consumer member. Because cancer is not one disease but many, FDA will now include a person who has experienced the specific cancer on each cancer-therapy advisory committee.
4. Fewer Applications for Additional Uses of Approved Cancer Drugs. Currently, many researchers ask FDA to review "supplemental" applications to study unapproved uses for the approved cancer drugs, even if they do not intend to market the drug for the new use. In many circumstances these additional applications are unnecessary. The FDA will make clear that it does not require such submissions, thereby eliminating any confusion about the necessity of the filing. Investigators can therefore devote more of their time to the challenges of cancer research.

In a related initiative, the FDA is publishing a series of five proposals designed to establish a uniformly high level of standards for mammography centers nationwide. These proposals, which cover such issues as quality assurance, equipment, facilities, and personnel, continue the successful implementation of the 1992 Mammography Quality Standards Act.

Mammography is currently the single best means of fighting breast cancer, which is expected to kill approximately 45,000 women in 1996. It is currently estimated that women in the U.S. have a one-in-nine lifetime risk of breast cancer.