ASCO 2012 Report – U.S. Cancer drug shortages plague treatment in certain areas
by Marybeth Burke – Some of the most essential mainstays in cancer treatment drugs for adults and children are in short supply, Michael Link, M.D., president of the American Society of Clinical Oncology (ASCO) announced at the society’s annual meeting in Chicago in June.
He said that 22 cancer therapies are affected and although certain crises have been averted, “We are not out of the woods yet.” The causes of the problem are not always clear, he said, adding that the most acute shortages tend to be in community center settings. The shortages occur mainly with generic drugs and the majority of shortages appear to be in the U.S. although some are global.
“This is about patients, people being able to get the treatments they need when they need them,” Sandra Kweder, MD, Deputy Director, Office of New Drugs, U.S. Food and Drug Administration (FDA) said. She said the shortage also affects pain medications and antibiotics in addition to cancer drugs. “This isn’t acceptable,” she said and added that, “The prevention of drug shortages at the FDA is our number one priority.”
She said that manufacturing problems, such as closure of a facility due to quality issues, are often at the root of the shortages. “Issues are mainly surrounding larger manufacturers of sterile injectibles,” she said.
Managing the Drug Shortage Problem
In 2012, 50 drug shortages have been prevented, Dr Kweder said. “The number of new drug shortages has declined slightly. With regard to oncology drugs, we remain concerned.”
She said the FDA is encouraging manufacturers to notify the FDA early of any potential shortages, so the agency can help the company avert the shortage. “One thing we know is that early notification by manufacturers makes a huge difference in our ability to prevent the public from bearing the burden,” she said.
Congress also is working on the problem, trying to develop legislation to address the issue.
ASCO has identified priorities for congressional action, said Richard L. Schilsky, MD, chair, ASCO government relations committee, University of Chicago. Those priorities include that Congress require FDA notification for market withdrawals or manufacturing interruption six months in advance; provide appropriate economic incentives; establish FDA user fees for manufacturers of generic drugs. “These are not the only steps necessary, but they are important ones,“ Dr Schilsky said.
“Congress is already working on some of these,” with the goal being to get the legislation to the U.S. President’s desk by the end of June or early July, he said.
A goal of the legislation is to help reduce the length of the FDA approval process of generic drugs from 30 months to ten. “Our goal is to not have 30 month queues for generic drugs,” Dr Kweder said.
Dr Schilsky said the issue is complex and multifaceted and called for a better understanding of the generic drug manufacturer business model.