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August 2, 2007

Should the FDA relax approval standards for biotech therapies?

Posted by Angel Gonzalez at 4:49 PM

Have biotech advances in cancer therapies evolved beyond the regulators' ability to handle them quickly?

Patients and biotech companies are simmering in frustration at the U.S. Food Administration's rejection of drugs they consider promising. A Wall Street Journal story published Thursday says these groups would like the FDA to allow products that fail to achieve their stated target, but are later discovered to be effective in certain groups among the people tested. That flexibility could save lives of terminally ill patients, they say.

The FDA argues that it's better to be safe than sorry, and that selecting successful sub-groups after the fact is bad science.

Some patient groups are taking an openly confrontational approach. We wrote Tuesday that CareToLive, a group representing prostate-cancer patients, is suing the FDA for rebuffing Provenge, Seattle-based Dendreon's lead therapy. The patient advocates say the refusal is the result of political rivalries within the agency, and is foiling some patients' last hope.

The push by such advocates, however, coincides with a nationwide call for more strict FDA supervision in the wake of drug safety scandals.


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Tricia Duryee
Tricia Duryee
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Angel Gonzalez
Angel Gonzalez
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