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FDA REPORT GAO - Report criticizes quality of Science and...

flounder

Well-known member
Jan. 29, 2008, 10:58PM
Budget boost suggested to help fix FDA troubles
Report criticizes low morale and quality of science


By KARL STARK
McClatchy-Tribune


WASHINGTON — If Congress offered the head of the Food and Drug Administration billions more to upgrade his embattled agency, he should be ecstatic, right?

But that wasn't quite the way FDA Commissioner Andrew C. von Eschenbach sounded Tuesday at an unusual hearing before the House Subcommittee on Oversight and Investigations.

The occasion was the reprising of a report, first released in December, in which several high-powered drug industry and academic experts dissected the FDA, saying that a persistent lack of resources over many decades had depleted the agency's ability to protect the citizenry.

"American lives are at risk," Gail Cassell, an executive at Eli Lilly and Co., who helped write the report, said at the hearing.

Among the report's findings:

• The agency's computer systems are antiquated.

• Its quality of science is backward.

• Its morale is poor.

• It is failing to protect consumers from the onrush of pharmaceutical ingredients and foodstuffs streaming in from overseas.

One expert, Peter Barton Hutt, who served as the FDA's general counsel in the 1970s, suggested Tuesday a doubling of the agency's $2 billion annual budget and a 50 percent increase in its staff over two years.

He noted that more than 100 statutes have increased the FDA's duties since 1988 without additional funding — even as more food and drugs are being imported.

Eschenbach was more measured than effusive during his testimony. He complimented the report, which he had requested from the agency's advisory Science Board, and said its findings were not a surprise. He also described himself as hard at work implementing its suggestions.

Eschenbach, however, would not say how much more money he had requested from President Bush in the fiscal 2009 budget. He said he would reveal that only after the president unveils his budget next week.

Eschenbach, a former official of University of Texas M.D. Anderson Cancer Center in Houston, did say the problems at the FDA were entrenched and would take sustained efforts to overcome. "This is not going to get fixed with one intervention," he said.

Several congressmen said they would like to see the agency receive more money. "In Texas, we would say 'Your ox is in a ditch and you need help getting it out,' " said Rep. Gene Green, D-Houston.


http://www.chron.com/disp/story.mpl/headline/nation/5496732.html

YEP, and industry oversight is part of the problem. you cannot let the wolf guard the henhouse. ...tss


January 29, 2008


The Government Accountability Office (GAO) today released the following reports, testimony, and correspondence:

TESTIMONY

Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical. GAO-08-435T, January 29

http://www.gao.gov/cgi-bin/getrpt?GAO-08-435T

Highlights - http://www.gao.gov/highlights/d08435thigh.pdf


Thu Dec 6, 2007 11:38

FDA IN CRISIS MODE, AMERICAN LIVES AT RISK


http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html


FDA SCIENCE AND MISSION AT RISK

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf


2001

DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen)

USA: Loch in der Mauer

Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas
verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden
sind lax.

Link auf diesen Artikel im Archiv:
http://service.spiegel.de/digas/find?DID=18578755


"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...


http://service.spiegel.de/digas/servlet/find/DID=18578755


APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


2001

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [[email protected]] Monday, January 08,200l 3:03 PM freas ...



http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Friday, January 25, 2008

January 2008 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://madcowspontaneousnot.blogspot.com/2008/01/january-2008-update-on-feed-enforcement.html


CJD BODY SNATCHERS

http://creutzfeldt-jakob-disease.blogspot.com/2008/01/cjd-hgh-body-snatchers.html



Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
 

Tex

Well-known member
What "sound science"? They are using that phrase as an excuse for the discretion they need to sell out the public interest.
 
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