Johnson & Johnson Is Latest FDA Casualty


Does the Food and Drug Administration approve drugs anymore? Or are we seeing the lame-duck leadership at the agency punt any action over to the next administration?

Late yesterday, the FDA gave Pfizer full, formal approval of its new HIV/AIDS drug. But that was only to be followed by news out of Dow component Johnson & Johnson this morning that the agency can't approve JNJ's new drug for hospital-acquired infections just yet. In early trading, JNJ is the biggest dollar and percentage loser in the sector.

It's just the latest in a series of delays or rejections out of the FDA. The agency recently said an anesthesia-related drug from Schering-Plough , already approved in Europe, can't be approved here. (The company says it will soon meet with the FDA to talk about turning things around.) At the company's R&D update meeting earlier this week, Schering-Plough Chairman and CEO Fred Hassan said he's looking forward to a changing of the guard at the FDA. The agency has twice delayed making a decision on whether to approve the bloodthinner Effient from Eli Lilly after putting the pill under what's called "priority review."

That's designed to put potential new products on a fast track. So much for that. And, of course, the example—albeit an older one by now—certain biotech investors like to hold up whenever possible is Dendreon . Despite an overwhelming recommendation from an FDA advisory committee to approve DNDN's prostate cancer drug Provenge, the agency refused to put the treatment on the market pending the outcome of another big clinical trial. And that's just to name a few.

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In the agency's defense, it has been understaffed, underfunded and at times overwhelmed. Right now, for example, it's dealing with a new infant formula safety scare. The failings and fate of the FDA happen to be the subject of a nitty-gritty piece in today's "Washington Post."

While President-elect Obama is making economic-related cabinet and administration appointments his top priority, biopharma companies, investors and reporters like me are anxiously waiting to hear who he's gonna pick to run the FDA. While it won't happen in time for Thanksgiving, someone who the industry and investors think would speed up the drug approval process while still watchdogging patient safety is something for which they would give thanks.

Have a good holiday. Beat the Irish! Although with the Trojans being a whopping 30-point favorite (has Notre Dame ever been that much of an underdog?), I don't think it's a question of whether USC will beat ND, but by how much.

My prediction: SC-56, ND-10, Charlie Weis-$15 million. I'll be sitting in the Notre Dame section (a Fighting Irish PR friend sold them to me for face value) at Saturday night's game, but given the economy and the Irish's record I'm thinkin' there will be more than a smattering of Trojans sitting near me...I hope.

Questions? Comments?