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The people who work at the Food and Drug Administration might have the best job ever. They get paid fees by drugmakers through the prescription drug user fee act (PDUFA) to make decisions about whether drugs are safe and effective or not, but if they miss a deadline, there's not a whole lot pharmaceutical companies and investors can do.
And these days, they've been missing a lot of deadlines. Let's take a look at a few drugmakers with marketing applications stuck in limbo and their chances for eventual approval.
A bloody thin chance
Eli Lilly (NYSE: LLY ) is on its second delay for its blood thinner prasugrel. The drug was supposed to be reviewed by June, but it was delayed until the end of September. And a month later we've still got no word from the FDA about an approval, although a drug industry publication claimed that the drug would likely need to go up for review by a FDA advisory committee. Eli Lilly says it knows nothing of the sort.
The only ones smiling about this delay are Sanofi-Aventis (NYSE: SNY ) and Brisol-Myers Squibb, which sell the already-approved blockbuster blood thinner Plavix. Any further delay -- or an outright rejection -- is a win for Sanofi-Aventis.
The problem with prasugrel, which will go by the brand name Effient if the FDA approves it, is that it might be a little too efficient. The drug seems to cause excessive bleeding in some patients.
This Fool's prediction: The FDA punts to an advisory committee, which says prasugrel is effective and mostly safe, and the FDA approves it with a restrictive label.
Approve the bugger already
The PDUFA date for Theravance's antibiotic Telavancin has long since passed -- it was July 21st -- but an approval doesn't seem imminent. The FDA asked an advisory panel to review the drug in the middle of next month.
This Fool's prediction: Considering that the FDA has turned down bids from Johnson & Johnson (NYSE: JNJ ) and Wyeth (NYSE: WYE ) to expand the labels of their already-approved antibiotics, Theravance definitely has an uphill battle.
The last shall be first
Motley Fool Rule Breakers pick, CV Therapeutics (Nasdaq: CVTX ) , has been waiting on three different label changes for its chest pain medication, Ranexa, since the end of July.
Ranexa is currently only approved as a second-line drug when other drugs aren't working, but CV Therapeutics is hoping to get the label changed to indicate that it's approved in a front-line setting. The company is also hoping to get Ranexa's label changed to indicate that it lowers glucose levels in diabetics and has anti-arrhythmic properties.
This Fool's prediction: Ranexa gets its expanded label for the front-line indication. The other two changes are a crap shoot.
The schizophrenic FDA
Ligand Pharmaceuticals (Nasdaq: LGND ) and marketing partner GlaxoSmithKline (NYSE: GSK ) have been waiting since mid-September for a decision about Promacta, their short-term treatment for a blood-clotting disorder, idiopathic thrombocytopenic purpura (ITP). That's on top of the three-month delay they got back in June.
This Fool's prediction: I don't have one. When an FDA advisory panel recommends approval, but also doesn't make a decision about whether or not the FDA should wait for more data, it's nearly impossible to figure out on which side the FDA will land, let alone when.
The D in PDUFA doesn't stand for deadline
Investors need to remember that, while the PDUFA provides goals of 10 months for standard reviews and six months for priority reviews, those goals are not binding.
In the past, it was an almost certainty that the goal would be met -- in fiscal 2005, the FDA met 89% of priority reviews and 99% of standard reviews. Now it seems that almost everything is getting delayed. Drugs will eventually get a decision, but investors should plan for a delay of at least a few months. In this capital market that could be a serious problem for cash-strapped drug developers.