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December 5, 2008

Sharfstein floated as FDA head

The Wall Street Journal reported today that Dr. Joshua Sharfstein, the Baltimore health commissioner, is the choice of some in Congress to head the Food and Drug Administration.

Sharfstein's name has emerged as criticism mounts over the possibility of Barack Obama naming a longtime FDA insider as interim head of the agency. The Journal reports that Rep. Bart Stupak of Michigan, an influential Democrat on a panel that oversees the FDA, is opposed to the appointment of any current FDA employee, saying the agency needs a top-to-bottom overhaul.

Sharfstein, who has ties to congressional Democrats from his time in Rep. Henry Waxman's office, is working on the Obama transition.

Read more to see the full Journal article.

DECEMBER 5, 2008
Lawmakers Divided Over Next FDA Head, Fixing Safety Issues Article
By ALICIA MUNDY

WASHINGTON -- A top House Democrat is asking President-elect Barack Obama to avoid naming any current officials of Food and Drug Administration to lead the agency, even temporarily, reflecting a divergence of views on Capitol Hill on how to fix the FDA's problems.

Congressional aides said Democratic officials have discussed naming Janet Woodcock, a longtime FDA official, as interim head after the expected departure of the current commissioner, Andrew von Eschenbach, a George W. Bush appointee. People close to the pharmaceutical industry also have been floating Dr. Woodcock's name as either interim or permanent FDA chief.

But Rep. Bart Stupak, a Michigan Democrat who holds a key post on the House committee that oversees the FDA, is seeking to forestall that choice. In a letter Wednesday to Mr. Obama, Rep. Stupak wrote, "I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA."

He added, "Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for." He called for a "complete change in the FDA's leadership." The letter doesn't name any officials.

The agency has come under fire from both parties in Congress in recent years for problems related to pharmaceutical safety, and Dr. Woodcock, director of the drug-safety division, has been involved in several controversies. They include contamination of the blood thinner heparin from Chinese ingredients; the 2004 withdrawal of the painkiller Vioxx, which was tied to heart attacks; and the FDA's delay in approving the Plan B contraceptive for over-the-counter sale amid political pressure.

Rep. Stupak, chairman of the Energy and Commerce Committee's investigations panel, called for Dr. Woodcock's resignation this year during the heparin scare. The ranking Republican on the committee, Rep. Joe Barton of Texas, has asked for a congressional agency investigation of the FDA on this issue. He also has cited Dr. Woodcock for failing to disclose some meetings with industry representatives as required by federal law. Her office called it an administrative error.

Dr. Woodcock's supporters include other Republicans in the Senate and House and some Democrats, as well as members of the medical community. Jeffrey Drazen, editor of the New England Journal of Medicine, said "it's clear that she's made some mistakes," noting the long delay in the removal of Vioxx from the market.

But he called her a "smart, capable leader" who is able to learn from her errors. He said, "Someone's going to have to run the agency while they decide on a commissioner."
Raising the pressure for a quick decision is the departure of Dr. von Eschenbach, who hasn't announced his plans but is expected to leave soon. An interim appointment would give the Obama team more time to choose a permanent commissioner and let interested parties argue longer for their candidates. Dr. Woodcock said she has met members of the Obama transition team, but she declined to detail the discussions.

Some agency critics say the FDA needs an outsider to give the agency a top-to-bottom overhaul. Names floated by these critics include Joshua Sharfstein, who is head of the Baltimore Health Department and successfully pushed the FDA to limit the use of over-the-counter cough medicines in young children.

Another name floated is Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who has raised questions about the safety of two blockbuster drugs, the anticholesterol medicine Vytorin and the diabetes pill Avandia.

Dr. Woodcock, a 20-year FDA employee, has defended both drugs publicly, and said in an interview, "People have convicted them without a trial."

Write to Alicia Mundy at alicia.mundy@wsj.com

Posted by David Nitkin at 3:56 PM | | Comments (1)
        

Comments

The FDA needs a bottom to top cleaning with a clean broom.
The past eight to ten years the agencies has been run by big business without regards to patient safety.
No persent personnel need to apply

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Annie Linskey covers state politics and government for The Baltimore Sun. Previously, as a City Hall reporter, she wrote about the corruption trial of Mayor Sheila Dixon and kept a close eye on city spending. Originally from Connecticut, Annie has also lived in Phnom Penh, Cambodia, where she reported on war crimes tribunals and landmines. She lives in Canton.

John Fritze has covered politics and government at the local, state and federal levels for more than a decade and is now The Baltimore Sun’s Washington correspondent. He previously wrote about Congress for USA TODAY, where he led coverage of the health care overhaul debate and the 2010 election. A native of Albany, N.Y., he currently lives in Montgomery County.

Julie Scharper covers City Hall and Baltimore politics. A native of Baltimore County, she graduated from The Johns Hopkins University in 2001 and spent two years teaching in Honduras before joining The Baltimore Sun. She has followed the Amish community of Nickel Mines, Pa., in the year after a schoolhouse massacre, reported on courts and crime in Anne Arundel County, and chronicled the unique personalities and places of Baltimore City and its surrounding counties.
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