Washington Editor

WASHINGTON - Almost simultaneous with receiving President Bush’s nomination to head the FDA on a full-time basis, Acting Commissioner Andrew von Eschenbach on Thursday outlined the next steps in the agency’s Critical Path Initiative.

"This really signals a major step forward in creating an FDA of the future," he said of Critical Path, a 2-year-old plan by which the agency is seeking to be more in line with new drug discovery techniques and ultimately shorten the time it takes for new drugs to get to patients. Doing so, von Eschenbach added, would require "an unprecedented sharing of information within the private sector."

To prod the industry, the FDA released a so-called opportunities list, which includes 76 potential undertakings to spur investigation into improving the entire drug development process. Among areas addressed in the initial list are projects to improve biomarker and animal models, streamline clinical trials, make better use of bioinformatics, enhance manufacturing and better deal with specific health needs such as those for pediatric patients.

The 64-year-old von Eschenbach, generally viewed as industry friendly, said increased attention in those areas from the public and private sectors would lead to a health care system that’s more personalized, predictive and pre-emptive. That, he added, would result in a focus on maintaining health rather than treating disease.

A cancer survivor and oncologist himself, with deep roots at M.D. Anderson Cancer Center in Houston, von Eschenbach called the initiative "a solution" to the troubles of drug failures.

He has held the position on an interim basis for six months, stepping into that role after Lester Crawford surprisingly bowed out after just three months atop the agency as its confirmed commissioner. Von Eschenbach had been serving as the director of the National Cancer Institute, although he eventually relinquished those day-to-day duties and said he would recuse himself from FDA work that could be a conflict of interest. However, he remains the official head of the NCI. (See BioWorld Today, Sept. 27, 2005, and Oct. 6, 2005.)

Before Crawford’s departure, he had served as acting commissioner for nearly two years, a period rife with controversies such as the drug safety scandal and the flu vaccine debacle, both of which hit late in 2004. Also in his tenure were political issues swirling around the agency’s decision to delay approving over-the-counter status for the morning-after contraceptive known as Plan B.

That latter matter is likely to haunt von Eschenbach’s Senate confirmation process, which already is being threatened by Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.). Both fought against Crawford’s nomination over the contraceptive issue, and issued a joint statement vowing to place a hold on von Eschenbach "until the FDA issues a decision on Plan B, yes or no."

Bush’s selection of von Eschenbach had been rumored for the past couple of weeks, although when he initially took the FDA helm, it was indicated that his status would be temporary. With that interim tab essentially removed, von Eschenbach eventually will appear before the Senate Health, Education, Labor and Pensions Committee, on which Clinton and Murray both sit.

A timeline for the Senate confirmation process has yet to be disclosed.

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