New Government Office Seeks To Speed Cancer Drug Approvals
By Rachael Myers Lowe
(July 16, 2004) - The Department of Health and Human Services and Food and Drug Administration today announced creation of a new office to coordinate under one roof all the regulatory functions of getting new cancer drugs from the lab to patients.
“The new Office of Oncology Drug Products (OODP) at FDA […] will bring together all the disparate pieces of the monitoring and approval of cancer drugs,” HHS Secretary Tommy Thompson told a news conference Friday.
“It’s going to be a wonderful way to get new drugs and therapies dealing with cancer to the market as soon and as efficiently and as safely as possible,” Thompson said.
The new office brings together three existing government functions currently conducted by more than a dozen offices involved in evaluating drugs and devises used to diagnose, treat and prevent cancer.
In making the announcement, Secretary Thompson said cancer has been a top priority for him since he took office in 2001. His wife is a breast cancer survivor and he revealed today that he’s been “hit again” with the diagnosis of breast cancer in his youngest daughter.
“Every one of us has family members or loved ones who have suffered from this terrible disease,” he said
It can take years for an anti-cancer drug to make it from discovery through clinical trials and finally to market. The hope is that by streamlining the regulatory process drugs will make it to patients more quickly.
Steven Glason, M.D., acting director of the FDA's Center for Drug Evaluation and Research, who is overseeing the restructuring effort, says it’s too soon to even guess how much more quickly new cancer drugs will be approved under the new bureaucratic structure. But Secretary Thompson says he hopes the restructuring will save time, money and lives.
“What we want, what the advocates want, is to get good medicines and therapies to the bedside as possible. That saves lives, saves suffering, and saves money so while I can’t tell you quantitatively if the $800 million plus it takes to move a drug through will be reduced appreciably but I would think that it is going to save dollars for the scientific community, the pharmaceutical community and especially the patients,” he said.
The OODP will have three review divisions. It will be responsible for the review of drugs and therapeutic biologics used to diagnose, treat and prevent cancer, including some compounds used in medical imaging. The new office will not cover cancer vaccines, a promising new field of cancer research. Cancer vaccine review will stay in the Center for Biologics Evaluation and Research.
A search will be launched this summer for a director of the new office.
Tom Hall, legislative director for the National Coalition for Cancer Survivorship told cancerpage his group is encouraged by the move but not happy that there’s no guarantee that an oncologist will be appointed OODP director.
Margaret Foti, M.D., of the American Association for Cancer Research called the restructuring “very exciting,” telling cancerpage it’s a “significant first step in accelerating the development of new drugs, new treatment and preventative drugs… any efficiency is going to help.”
cancerpage.com |
