FDA's Pazdur in the middle of intense debate

Tue, 18 Mar 2008 07:59:59 -0400

The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Patient groups and developers complain that Pazdur's demanding style has raised the bar too high for many cancer drugs, leaving desperate, dying patients without drugs that could make a significant difference in their battle against the disease. Others, though, say the FDA should employ even tougher standards in order to protect people from harsh therapies that offer little or no hope of fighting cancer.

The Wall Street Journal reports that Pazdur has effectively reached out to one of the most important patient advocacy groups. And he's quick to pick up a dinner tab, anxious to avoid the appearance of a conflict with anyone who may be involved in a cancer program that could wind up under his review. Only a relatively small percentage of new cancer drugs make it all the way through to a positive opinion at the FDA, but regulators under Pazdur have demonstrated a willingness to weigh benefits--even disregarding its panel votes when the agency feels that patients should have access to a therapy.

- read the profile in the Wall Street Journal

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