Analysis: Pharma warms to FDA pick

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http://www.upi.com/HealthBusiness/view.php?StoryID=20060316-042146-6334r Analysis: Pharma warms to FDA pick By STEVE MITCHELLUPI Senior Medical Correspondent WASHINGTON, March 16 (UPI) -- The Bush administration's nomination of von Eschenbach to head the Food and Drug Administration will be a win for industry if he's confirmed by the Senate, analysts told United Press International. "I think it will be a positive for biotech and pharma investors," said Schmidt, an analyst with S.G. Cowen. "He seems to understand the industry's need for straightforward communication on the drug review process and the fact that time is money," Schmidt said. "Also, he realizes that there is a risk and a benefit to approving any new product and that decisions should be based upon this balance," he added.

"I think the general thought is this seems to be positive," said Henry, an analyst with Oppenheimer and Co. Henry added that given von Eschenbach's background in oncology, "it's good for biotech." Von Eschenbach, who is a cancer survivor, has headed the National Cancer Institute since 2002 and also served as executive vice president and chief academic officer of the University of Texas MD Cancer Center in Houston. The Pharmaceutical Research and Manufacturers of America applauded President Bush's choice, saying von Eschenbach would benefit the FDA. "Dr. von Eschenbach has both tremendous research and management credentials," PhRMA President and CEO Tauzin said in a statement. "His leadership, and the expertise of the dedicated FDA staff, will help ensure that Americans continue to see the health benefits of the most safe and effective drug approval system in the world," Tauzin added. But Henry noted that since von Eschenbach has been acting FDA commissioner since September, it probably won't significantly affect the agency or industry if he's officially confirmed as permanent commissioner. "The more interesting part of the story is whether he'll get through or not because of Plan B," Henry said. Sens. Clinton, D-N.Y., and Patty Murray, D-Wash., placed a hold on von Eschenbach's nomination in the Senate Wednesday that they said would last until the FDA issued a decision on the controversial proposal to make Duramed's emergency contraceptive pill Plan B available over-the-counter. The FDA has delayed the decision for three years. Von Eschenbach also will face a fight from consumer advocacy groups. Public Citizen opposed his nomination, saying in a sharply worded statement that if he was confirmed, he would be "yet another Bush appointee whose main reason for being selected is that he is a family friend, someone

who has been warmly embraced by the regulated industries -- especially the pharmaceutical industry -- and someone who has been and will continue to be loyal to the White House agenda." Sidney Wolfe, director of Public Citizen's Health Research Group, told UPI von Eschenbach is "well-liked by the pharmaceutical industry because he's tilted toward making it easier to get drugs approved." Wolfe also expressed concern about the emphasis being placed on the Plan B decision. "I'm concerned everybody is willing to go up or down on him on this Plan B thing," he said. "To have him get through is sort of opening up a can of worms because it's hardly going to be the only issue he's been on the wrong side of." Woolley, president of Research!America, a group comprised of pharmaceutical and biotech companies, medical research institutions and patient groups, did not share Public Citizen's concern. Von Eschenbach "really understands the

value of working with the patient community" and is adept at applying science to regulatory decisions, Woolley told UPI. "We can count on him to assure that evidence is the basis for decision-making because he understands science," she added. The FDA did not respond to UPI's request to interview von Eschenbach.

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