The WSJ reports this afternoon that the FDA said six drug makers, who received accelerated approval for their cancer treatments, did not complete follow-up studies that were promised in exchange for that approval. Among the six are Amgen, GSK and Eli Lilly.
Richard Pazdur, head of the FDA's cancer division, said, "These confirmatory trials are as important -- if not more important -- than the initial trials leading to the accelerated approval." Some of the companies have been delinquent for more than six years.
The FDA has the power to fine companies millions of dollars or to even withdraw approval. My question, "Have they ever done so?" If not, I wonder what the Company's incentive for doing the follow up studies might be? I know their disincentive.
For example, Roche's Avastin and AZ's Iressa are two drugs that failed to show benefit in follow up studies for certain approved applications. The result was the drugs lost their approval - a powerful disincentive to report I'd say. To date, five drugs failed to confirm benefit in follow up studies.
Would the number have been higher if all the drugs receiving accelerated approval had met their post-market reporting requirments? We may never know.
Posted by Bruce Lehr Feb 8th 2011.
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