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FDA At Level "Orange" Safety Warning?

The Food and Drug Administration continues to get a lot of attention and scrutiny. In an editorial over the weekend "The New York Times" wrote,"The F.D.A. desperately needs an infusion of money and talent." Then, "USA Today" today is running a front-page articleon somethingI recently blogged aboutand other reporters tackled a few weeks ago regarding the agency approving so few drugs last year.

In the wake of a Congressional hearing last week into the FDA's problems, the agency announced this afternoon that it wants $2.4 billion for the 2009 fiscal year--an increase of 5.7 percent. Part of that money will "cover cost of living increases for FDA employees that perform the agency's scientific and highly specialized public health mission." The agency has a lot of turnover. You can read all the detailed FDA line items here.

In a research note to clients this morning Needham & Co.'s biotech analyst, Dr. Mark Monane, writes about the low number of drugs approved by the FDA in 2007. "We think the dual phenomenon of the tough FDA and challenging (clinical) trial design are already factored into current investor expectations," he says. The "tough" FDA was in evidence once again last Friday with its issuance of a "Public Health Advisory" on Pfizer's stop-smoking pill Chantix.

Miller Tabak healthcare analyst Les Funtleyder says the agency is risking the public getting a case of what he calls "safety warning fatigue" and is suggesting the FDA adopt a color-coded warning system similar to the terrorism threat level. He writes, " In our judgment the FDA needs to be more specific on the actual risk. Perhaps a color code based upon the hazard ratio of relative risk of a given product may be more instructive although color coding's success in terrorism warning has been the subject of some debate."

Right now, the agency has a system that may be difficult for the public to interpret. It includes something nebulous called an "Early Communication". The next step up--a "Public Health Advisory"--is easy to understand. And then we've got the dreaded "Black Box" which gets its name from the black-lined square that surrounds a stiff safety warning on a drug label.

By the way, I don't know anyone who reads all that fine print that comes inside or stapled to the bag containing a prescription. So, perhaps Les is onto something. Maybe put the label information on colored paper to coordinate with its safety risk level. On the other hand, can you imagine how subjective the assessment of color-coded level could become? The drug companies, advisory committees, public safety advocates and the FDA would have a colorful debate, to say the least.

Questions? Comments? Pharma@cnbc.com

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