FDA has Been in Turmoil Under Bush....Cronyism/Crookery...

[KoKo]

Former Bush Press Secretary Scotty McClellan's brother Mark McClellan came in in 2002 after the agency had been without a head for 20 Months...then he resigns and this Lester crawford takes over and resigns after 18 months. Both McClellan and Crawford had Bush and Big Pharma Agendas....and that should make us worry about any new drugs or vaccines that were approved under both of them. The Safety and Legitimacy of new drugs is too important to be left up to Cronies and Ideologues...:-(

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Bush nominates Mark McClellan to head the FDA

BY LISA TREI

Mark McClellan, associate professor of economics and of medicine, has been nominated by President George Bush to lead the Food and Drug Administration (FDA).

McClellan, 39, has been on leave from Stanford since spring 2001 when he joined the Council of Economic Advisers as Bush's top adviser on health policy. His nomination now goes before the Senate for confirmation.

Kathryn McDonald, executive director of the Center for Primary Care and Outcomes Research (PCOR) in the School of Medicine, said McClellan would be a capable FDA commissioner. "He's an incredibly smart scientist and social scientist," she said. "He's very energetic and gets things done. From a Stanford perspective, he's top-notch."

Professor Alan Garber, who also holds joint appointments in economics and medicine, said McClellan is qualified to be "an agenda-setter" at the FDA. "He has tremendous analytical skills," Garber said. "He's an accomplished economist, an excellent physician and has deep policy experience." During the second Clinton administration, McClellan served in the Treasury Department as a deputy assistant secretary.

Garber brushed aside concerns that McClellan has no experience in significant areas of FDA concern, such as what to do with tainted food and how to decide whether a drug is safe enough to be sold. "The FDA mandate is so broad that it makes tremendous sense to pick someone who can learn quickly and not be an expert in just one thing," he said.
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All news for October 2006

Lester Crawford wins top FDA post
FDA outlines new risk-based strategy on GMP
FDA in the dock over drug scandals
cGMP revamp reaches conclusion in US
GMP high on agenda as FDA reaches ‘critical period’
US changes label requirements for OTCs

26/09/2005 - The US Food and Drug Administration (FDA) has found itself once again without a permanent Commissioner after the current incumbent - Lester Crawford - resigned after 18 months in the post.

Crawford was appointed acting FDA Commissioner March 2004, after having stepped into the job on an interim basis on two prior occasions. He has been acting Commissioner since Mark McClellan departure left to head up the Centres for Medicare & Medicaid Services, and after a long, contentious and drawn-out appraisal process was finally granted the permanent position in July.

However, his application for the permanent post and subsequent tenure has been dogged by persistent criticism on issues such as the FDA's recent record on monitoring drug safety – a debate brought to a head by the withdrawal of Merck & Co's painkiller Vioxx (rofecoxib) - the politically-sensitive issue of expanding access to emergency contraception and his opposition to the re-importation of prescription drugs.

The FDA's postponement last month of a decision on whether Barr Laboratories' emergency contraceptive Plan B should be made available over-the-counter - which prompted 13 US Senators to seek a non-partisan probe into the agency's actions and the resignation of assistant FDA Commissioner for Women's Health Susan Wood – has been a key source of criticism for the Commissioner.

At the time, Crawford said that unresolved regulatory issues made it impossible to approve expanded use of the emergency contraceptive, particularly whether the same drug could be sold both by prescription and over-the-counter for the same indication.

In his resignation letter, Crawford said that at the age of 67 it was time to step down, while the department of Health and Human Services, which oversees the FDA, said the decision was made for personal reasons. President George W Bush has asked the National Cancer Institute's director, Dr Andrew von Eschenbach, to be the FDA's new acting commissioner while a permanent replacement is found.

http://209.85.165.104/search?q=cache:GYvJa4cuDRUJ:www.in-pharmatechnologist.com/news/ng.asp%3Fid%3D62774-fda-lester-crawford-commissioner+Mark+McClellan+resigns+from+FDA&hl=en&ct=clnk&cd=4&gl=us&client=firefox-a

[KoKo]

1. Kick...trouble with keyboard made a mess out of OP of this...

sorry..

[barb162]

2. The drug companies basically are running that place now

It has to change

[KoKo]

3. And the Bush Policy of appointing brothers, sisters, children, cousins

ALL TEXAS CRONIES and FRIENDS of His and Poppy's has got to stop. No more of this "FAMILY GOVERNMENT." And that goes for BOTH Parties! Enough is enough. Senators and Congresscritters with wives and husbands, brothers and sisters and children employed as LOBBYISTS, too.

It's completely out of hand. And, look at the MEDIA...They all are embedded with each other with sons of reporters, daughters of newsmen, wives, husbands and even ties into lobbyists and the administrations they report on.

There's nothing left for folks without "CONNECTIONS!" No wonder they don't listen to US OUT HERE anymore....

[barb162]

4. I know, I know....

[antigop]

5. "that should make us worry about any new drugs or vaccines " -- does that include Gardasil? n/t

[TZ]

6. This is not a surprise to those of us in the sciences

He has done this to most of the regulatory agencies and even scientific establishments like NIH, NASA ect. But before some people use this sad fact to push an agenda please keep in mind there are still good people working in places like the FDA and they try their best to keep to the highest standards even with what has been done. And sometimes other groups can pick up the slack when certain agencies drop the ball. Case in point- here in md instead of the EPA doing some work/inspections WSSC has picked up in that area. I would tend not to trust political appointees in many of these places but the scientists and researchers are generally (again there are exceptions) fairly honest. All I ask is people bear that in mind.

[KoKo]

7. kick....not Dissing FDA Employees..but Leadership from the Top Down

who make the POLICY! and can overide the career folks to get the Drug Companies preference for whatever NEW DRUG to SAVE THE WORLD comes out and KILLS FOLKS...meantime their LOBBYISTS fight Trial Lawyers to STOP any Lawsuits to REPRESENT THOSE MAIMED AND KILLED BY thier BUSH POLICIES.

That's all I'm trying to say. Be cautious in what you take unless you are at "death's door and all options have expired" and please wait a bit before giving your children stuff "under Bush" that might have had minimal testing and been put out on the Marketplace before proper testing had taken place...just to get Big Pharma's Stock Up for the CEO/CFO/COO.

That's all I'm saying...CAUTION!

[KoKo]

8. FDA isclosing Labs when they don't even have a Commissioner?

http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=230502&mesg_id=230502

[bobthedrummer]

9. kick