The FDA's accelerated approval program has done little to speed new cancer therapies through the research phase, according to a study funded by the National Cancer Institute. Comparing the R&D records of 19 cancer drugs put on an accelerated approval track and 32 oncology drugs that advanced along a regular development path, all the drugs took an average of seven years to get from the lab to an approval.
"This is a disappointment," says Charles Bennett, a professor at Northwestern University Feinberg School of Medicine. The accelerated approval process was intended to speed new drugs to patients who had terminal illnesses. "We're not talking about people with skin conditions. These people are going to die."
Bennett and his co-authors say that the program began well enough, but was hampered by the FDA's insistence on large human trials for new drugs ahead of an approval. Those large trials can add five years to the clinical trial calendar and $600 million in costs--something small biotech companies simply can't afford.
- read the report from USA Today