FDA Delays Take Toll on Neuroscience Drug Development
Posted by Shirley S. Wang
November 10, 2008, 4:03 pm
The FDA has even the neuroscience crowd scratching their heads.
Some folks from the Neurotechnology Industry Organization, a trade group for neuroscience companies, and three of its members stopped by Health Blog HQ today. Our chat really heated up when it turned to the current regulatory environment.
While recognizing that the FDA is “criminally understaffed” and in a difficult position given budget constraints, the agency’s performance is at its “nadir,” said Ron Cohen, CEO of Acorda Therapeutics. Cohen’s company is working on a Fampridine-SR, a multiple sclerosis treatment, which is expected to be filed for approval with the FDA early next year.
The FDA’s delays in meeting deadlines for some approval decisions and as well as in scheduling other meetings with companies can stall drug development up to half a year, Cohen told the Health Blog. For a biotech company struggling with financing, the extra time could mean that it goes out of business. In Cohen’s view, “the current lack of funding and resources at the FDA is the one of the gravest threats to innovation.”
The agency is also too focused on safety — a trend that many in the industry believe has contributed to the slowdown in the drug approval process — when the emphasis should be on the benefit-risk ratio, Ulli Hacksell, CEO of Acadia Pharmaceuticals, told the Health Blog.
A potential solution? Rather than requiring additional Phase III clinical trials, the FDA could approve treatments pending the review of specific, planned post-marketing studies — a provisional approval, Hacksell told the Health Blog. The FDA could make these Phase IV studies tougher and make sure they are done, but this way the drugs could come to market more quickly so patients who need them could have access.
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