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Saturday, 03/11/2006 11:41:42 AM

Saturday, March 11, 2006 11:41:42 AM

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Thank you to all for the research that you have provided.

I was reading the Wall St Journal and thought this was interesting concerning PPHM/FDA.

Bush Is Set to Nominate
Acting Chief as Head of FDA

By ANNA WILDE MATHEWS and JENNIFER CORBETT DOOREN
March 10, 2006; Page A15

WASHINGTON -- The White House is expected to nominate the acting commissioner of the Food and Drug Administration to formally head the agency.

Andrew von Eschenbach, 64 years old, is likely to be named in the next several weeks, people with knowledge of the matter say. But that could still stall over questions about whether Dr. von Eschenbach would have to give up his other job, as director of the National Cancer Institute, upon being nominated. He would likely face a tough confirmation process, tangled with controversial issues such as the Plan B emergency contraceptive and stem-cell research.

The last FDA commissioner, Lester Crawford, won confirmation only to resign last September after two months, a move likely tied to questions about his finances. Mark McClellan, the previous FDA leader, stepped down in March 2004 after about 16 months to run the Medicare program.


Dr. von Eschenbach, a urologic surgeon and cancer survivor who previously was executive vice president of the M.D. Anderson Cancer Center at the University of Texas in Houston, is identified with an aggressive goal of ending suffering and death because of cancer by 2015. Seen as an advocate of speeding approval of promising drugs, he will win support from industry but likely face opposition from lawmakers focused on drug safety, such as Iowa Republican Sen. Charles Grassley.

"He'd be a great FDA commissioner," said James Greenwood, chief executive of the Biotechnology Industry Organization. But "we've learned that it's easier to confirm a Supreme Court justice than it is an FDA commissioner."

Any FDA nominee will come under sharp pressure from both ends of the political spectrum. Democrats have attacked the agency's handling of a bid to sell the emergency contraceptive known as Plan B without a prescription, which stalled under Dr. Crawford. Republicans may want to grill Dr. von Eschenbach about the FDA's plans for condom labeling and the abortion pill mifepristone, which has been potentially tied to a handful of deaths. The agency has scheduled a scientific meeting that would address that and other infection-related issues.

A spokesman for Senator Michael Enzi, chairman of the committee that oversees the FDA, said the Wyoming Republican "continues to believe it is critical that the FDA have a Senate-confirmed leader at the agency's helm," though he said Mr. Enzi has told the White House he "believes it's essential that the Plan B issue be resolved before the Senate votes on an FDA nominee." A spokeswoman for Sen. Edward Kennedy of Massachusetts, the ranking Democrat on the committee and a fulcrum vote on any FDA nominee, said he believes the "next commissioner must have the capacity to see that FDA once again sets the standard for quality, sound science and integrity."

Aside from the highly charged reproductive-rights matters, Dr. von Eschenbach likely will face difficult questions over a range of FDA-related issues, including the possibility of copies of biotech medicines. He may also be asked about his unusual dual job at the FDA and the cancer institute, which he has headed since 2002.

Sorry Jazz/CJ, I couldn't provide the link from the Wall St Journal.


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