Analysts: New FDA rules inspire tougher drug reviews
The analysts at Concept Capital did the math on this year's decisions by FDA expert panels and reached the disturbing conclusion (for biotech execs, anyway) that the numbers clearly indicate that the panels are getting tougher.
On 23 tries related to new chemical entities and major new indications, developers won 12 votes in favor of recommendation--a 52 percent rate of approval. "The percentage of 'yes' recommendations is down significantly compared to 2009 and 2008, when 75 percent and 80 percent of drugs received positive recommendations," Ramsey Baghdadi, an analyst with Concept Capital, tells Adam Feuerstein at TheStreet, which has the full story.
What's behind the new level of intensified criticism? New rules require a review now for most new therapies, which is triggering more votes. And the analysts insist that tougher conflict-of-interest rules are forcing the agency to pick less experienced people for the panel. That could be bitter news for anyone up for a review. A negative vote can torpedo a new drug's chances at the agency.
- here's the story from TheStreet
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