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To: redfish who wrote (35674)	8/23/2005 12:23:14 AM
From: Chispas	Read Replies (2) \| Respond to of 116555

MRK's still in the news .... . 08/22/05: The Outlook For Drug Development From FDA Commissioner Lester Crawford JEFF YASTINE: Merck & co (MRK) losing $0.17, more selling following Friday`s Vioxx jury award. The stock got as low as 27 before rebounding a bit. CS First Boston upgraded the stock based on valuation, but warned that its dividend could be cut if the company does another restructuring. SUSIE GHARIB: Well, as Jeff just mentioned, Merck stock remains under pressure after that huge jury award. But the heat is affecting other drug companies, as analysts and industry insiders predict the verdict will make it tougher and more expensive to develop new drugs. To find out more about how the Vioxx controversy is affecting the drug industry, Washington bureau chief Darren Gersh talked with FDA Commissioner Lester Crawford today. Darren began by asking Crawford what he thought of the Vioxx verdict. DR. LESTER CRAWFORD, FDA COMMISSIONER: We don`t get into those kind of things, the legal ramifications of the drug approval process. But we are, obviously, very much interested and very involved. We -- we had some issues last year with that -- with the Cox 2 inhibitors as did other countries, so we convened an advisory panel and they gave us great advice. We then took the drug Bextra off the market after consultation with its sponsor, allowed Celebrex to remain on the market. That advisory committee had said that Vioxx was a drug we might should reconsider. As you know, it had been voluntarily taken off the market. So that advice still is out there. We haven`t done anything with it at this point. But we have one of those kinds of drugs left on the market and that is Celebrex. DARREN GERSH, NIGHTLY BUSINESS REPORT CORRESPONDENT: In light of the trial, there are a lot of analysts and industry insiders who are arguing that drug development will be slower, more costly, that it will involve larger patient trials. What is your view? CRAWFORD: Well, I don`t think it`s going to affect how we do business. We probably won`t change. However, safety evaluation is getting more sophisticated. We have a new series of initiatives that is called the critical path initiative. And what that does is to try to make a science out of what FDA does, the effectiveness side as well as the safety side. So we`re looking for what are called biomarkers, indicators of either effectiveness or toxicity. We will be better at what we do. And some people will look upon that as being an increased stringency on our part. We don`t see it that way. We see it as being more efficient. GERSH: Although one industry analyst consultant I spoke with said, he said there has been a silencing of the drug pipeline. That basically people are holding back and that they are waiting to see how all of this shakes out and that new drugs aren`t moving forward. Are you seeing that? CRAWFORD: We did an evaluation. As commissioner you are always concerned about that. So every six months or so, I ask that we compare that particular part of history to a year earlier and then five years beyond, and so forth. We just completed that. We actually found that in the first six months of this year, the time it takes to get a drug on the market after we say yea or nay, has gone down to 10 months from 12 months. So actually we are in -- improving the efficiency rather than not improving it. And that is with some considerably effective new tools to evaluate safety as well as effectiveness. So it is actually going in the other direction. GERSH: But that is the approval process. But are you concerned that drug companies now are worried that it is going to cost them more to make a new drug? They are concerned and they are telling us and analysts that it`s going to -- that the FDA is getting tougher on them. Are you concerned that the drug approval process -- I`m sorry, the drug discovery process is slowing down and will take longer and will be more costly? CRAWFORD: Well, I -- you know, we don`t have much way of knowing what is happening within the companies until they submit to us. I -- and I couldn`t really speculate. But I -- I don`t know that we have enough time yet, that verdict was only a few days ago, to note that there is a trend. GERSH: But the analysts who say FDA is getting tougher, the industry consultants who say FDA is getting tougher and even some of the executives who say the FDA is getting tougher and more cautious, you are telling them today that`s not the case? CRAWFORD: Actually, it`s going in the other directions. We are very careful. We are very cautious, always have been. But the time it takes to get a drug on the market, the first six months of this year as opposed to the first six months of last year is actually less. GERSH: Dr. Crawford, FDA commissioner, thank you for your time. CRAWFORD: Thank you very much.