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Fmr. FDA commissioner calls for overhaul of medical approval process
Thursday - 2/23/2012, 10:55am EST
"I think today the biggest concern that's on people's minds is the regulatory process itself needs to be modernized and, if you will, streamlined because the longer it takes to bring these products to patients, the fewer lives are saved," said Andrew Von Eschenbach, former FDA commissioner and now the leader of an effort to reform the FDA.
Project FDA, an initiative of the think tank Manhattan Institute, is advocating a more transparent and efficient way to bring products to consumers. The push for reform comes as Congress reauthorizing the fees companies pay for the medical reviews.
"It's a critical time to address, Do we have the regulatory processes and an agency in place that's able to address the amazing challenges we're facing today to stay at the forefront of medical research bring these products to patients?" Von Eschenbach said.
The complexity of new products has put "a great deal of burden" on the agency to "get it right," Von Eschenbach said. "There is the tendency for it to be more cautious and slower in order to be certain ... it's not adversely affecting safety."
In the past, FDA has recognized the need to speed up its approval processes. Twenty years ago, in the face of the AIDS and HIV epidemic, the agency created an "accelerated approval" process that allowed treatments to be considered based on indirect and substitute measurements that represented meaningful outcomes. For example, FDA could use the process to approve a drug that shrunk a tumor without having to wait to find out if the patient lives longer.
Another process, called Fast Track, is designed to speed up the approval of drugs that address an "unmet medical need," according to the FDA website.
"Those two processes have been very effective in those areas, but the problem is that's 20 and 15 years ago," Von Eschenbach said. "Rather than being the exception to the rule, they need to be the routine way we bring treatments for Parkinson's, Alzheimer's and modern therapies for diabetes and all the rest."
The reforms that Project FDA are advocating go behind more funding and training, and the changes will require congressional mandates, he said.
"We need to be as innovative with regard to regulation as we're being innovative with regard to development of these products," Von Eschenbach said.