Interesting WSJ editorial re FDA's Iressa decision and its implications.
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A Rare Victory at the FDA
Maybe there is some common sense at the Food and Drug Administration after all -- or at least among the medical experts the agency chooses to advise it.
When an FDA advisory panel convened Tuesday to consider AstraZeneca's application for the cancer drug Iressa, it was expected to send the company back for more data. But spurred on by powerful testimony from patients who would almost surely be dead without the drug, and over the apparent objections of hyper-cautious FDA staffers including oncology chief Richard Pazdur, the panel voted 11-3 to recommend Iressa for accelerated approval.
"Ten percent [response] is pretty substantial," noted panel chairwoman Donna Przepiorka of the University of Tennessee. "I've never seen a lung cancer patient whose cancer went away by itself. Very clearly there are patients whose cancer went away with Iressa." If the agency now acts on the recommendation, Iressa will be the first of a new class of drugs called growth-factor inhibitors that promise new hope for patients who don't respond to chemotherapy.
The vote also offers hope to beleaguered pharmaceutical and biotech industries that have watched Dr. Pazdur question the very concept of accelerated approval; stocks, including ImClone's, were up sharply on the news. Clearly members of the general oncology community, who actually treat dying patients and from which the panel was drawn, are in no mood to quibble endlessly over data. If the Iressa precedent stands, it will create enormous incentives for investment in new drugs.
But reaping the full fruits of this victory will require more than the occasional panel revolt; the FDA is not obliged to follow a recommendation. It will take policy leadership from the top, which is why the nomination yesterday of Mark McClellan of the President's Council of Economic Advisers to fill the long-vacant post of FDA Commissioner is welcome news. A physician and economist, Dr. McClellan surely understands that regulation has its risks too. If he can bring some sense and certainty to the FDA's opaque approval procedures, he'll be doing the right thing by patients and the right thing for an economy badly in need of a new growth industry. |
