FDA Sets Up Cancer Office to Speed Up New Drugs

The U.S. Food and Drug Administration plans to speed up government approval of new cancer therapies by creating an office dedicated to medicines, the agency announced on Friday.

The new office will oversee a variety of different cancer drugs, including biotech drugs and related products like dyes used for imaging technologies. Such “changes will make the review process stronger and more efficient,” said Health and Human Services Secretary Tommy Thompson. The new office will centralize all cancer-related drug efforts, allowing for better coordination among FDA reviewers, reduced costs and less duplication, officials said. While the new structure aims to speed up the approval process, “the reality is that oncology approvals already go pretty quickly if the drug has been shown to be effective,” said John Jenkins, head of the FDA’s Office of New Drugs. The FDA also announced an agency-wide program to coordinate other cancer efforts between departments and among other agencies, including the National Cancer Institute (NCI). Those efforts could help spur the development of newer products, officials said. Thompson also said he hoped the coordination would help lower drug costs by saving money for scientists and drug companies. A FIRST STEP Advocates for cancer patients praised the agency’s new efforts as a crucial first step in improving care. “It will make an enormous difference to patients,” said Ellen Sigal, head of the Friends of Cancer Research, which lobbied for the consolidation. “Six months (or) a year in the life of a cancer patient is an eternity.” The new office is key as new, more complex treatments like combination therapies emerge, Sigal said.Advocates urged the agency to do more. Some said the new office should include more cancer products, including diagnostic tools and vaccines. Others said broader policy changes were needed. Frank Burroughs, head of the Abigail Alliance for Better Access to Development Drugs, said expanded clinical trials and wider use of experimental drugs, among other efforts “could get life saving drugs to many people years earlier.” Cancer is the second leading cause of death in the United States, and about 1.3 million people are expected to be diagnosed this year, according to NCI. (Source: U.S. Food and Drug Administration: Reuters Health News: Susan Heavey: July 2004)