FDA Chief: Cuts Threaten Drug Approvals
FDA Chief: Cuts Threaten Drug Approvals [Boston Herald]
From Boston Herald (MA) (March 16, 2013)
March 16--Lorraine McCartin’s breast cancer has been in remission for more than a year, thanks to a drug called Kadcyla that the Food and Drug Administration only recently approved solely for patients with late-stage breast cancer.
In 2010, McCartin, 56, of Hanson was able to get access to the drug only by flying to Virginia every three weeks as part of a clinical trial, an expense a friend who also had breast cancer couldn’t afford. The friend died three months ago.
"I’m out here for all those other women who were turned away," McCartin said yesterday as she and her husband joined a half-dozen other demonstrators outside the MassBio annual meeting in Cambridge to protest what they see as a sluggish drug approval process.
Inside the meeting, the head of the FDA told about 400 biotechnology leaders that the federal agency is working to expedite the approval of safe new drugs, but across-the-board federal budget cuts threaten to hamper its efforts.
Commissioner Margaret Hamburg said she is hoping Congress will enable the FDA to access user fees the industry pays for the agency’s operating expenses.
"We need to work together to fix this problem in the short and long term," Hamburg said. "We simply cannot put on hold the progress that’s been made."
Several of the 47 drugs and other treatments approved last year were developed in Massachusetts, she said.
One treatment was approved in less than three months.
Hamburg said the FDA is trying to ensure regulatory flexibility and consider patients’ views.
"We’re trying to achieve a balance between benefits and risks," she said, to help speed the drug approval process while protecting public safety.
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Posted: March 2013