For F.D.A., a Major Backlog Overseas

[flashl]

Source: NY Times

WASHINGTON — The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators.

Computer systems at the drug agency are so inadequate that it can only guess the number of the plants, and it cannot produce a list of those that have not been inspected. The situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where F.D.A. inspections are few.

These findings come from a series of reports by the Government Accountability Office — obtained by The New York Times — scheduled to be released Tuesday at a hearing of the House Energy and Commerce Committee.

The reports and a recent assessment by the agency’s Science Board conclude that the F.D.A. is so overwhelmed by a flood of imports that it is incapable of protecting the public from unsafe drugs, medical devices and food.

“This is a fundamentally broken agency, and it needs to be repaired”

NY Times

Read more: http://www.nytimes.com/2008/01/29/washington/29fda.html?hp

---

More bad news from the FDA.

[mwb970]

1. Somebody should make a list of everything that is said to be "broken".

There is a constant stream of reports, like this one, stating that one or another of the systems that sustain our nation and society is "broken". This is the exact word that is always used. Without even researching the question, I can recall reading recently that:

The FDA is broken.
Our health care system is broken.
Our military is broken.
Our election system is broken.
The Department of Justice is broken.
Our political system is broken.
Washington is broken.
The Republican Party is broken.
Our whole government is broken.

To top it off, bush speaks in broken English, he breaks all his promises, and he has left the country flat broke.

[flashl]

3. The magnitude of this dysfunctional goberment while spending trillions is overwhelming sometimes. nt

[SpiralHawk]

2. "Yay, we drowned America's government in the bathtub." - Republicon Homelanders

"We have triumphed. The FDA is useless. The EPA is staffed by corporate greedheads. FEMA is feckless. The courts are packed with troglodyte fascists. The pot holes are manifesting everywhere on the interstate highway system. The ports are undefended. The military & veterans are screwed, while our private, profit-making Mercenary Armies are thriving. Gas prices are through the roof. Etc. etc. etc. Yay for Commander AWOL & our belovedly corrupt & incompetent republicon homelander cronies.

"Please vote for us again, you pathetic American proles, you, so that we can steal your tax money, raise your debt, and generally screw you some more. Smirk, smirk, smirk."

- Republicon Homelanders

[flashl]

4. Hearings today, House Energy and Commerce investigations subcommittee

Overseas Medical-Device Makers Get Infrequent U.S. Inspections

Jan. 29 (Bloomberg) -- The Food and Drug Administration isn't meeting requirements to inspect U.S. medical-device makers every two years, and monitors overseas producers even less frequently, according to a government investigator.

Companies in the U.S. that make so-called high-risk devices, such as pacemakers for the heart, are inspected for safety once every three years, said Marcia Crosse, director of health care for the Government Accountability Office, the investigative arm of Congress, in testimony prepared for a House hearing today. The FDA checks companies overseas that make the same type of devices for sale in the U.S. every six years.

The House Energy and Commerce investigations subcommittee is holding a hearing today examining the FDA's oversight of food, drugs and medical devices. The committee plans to discuss a November report by a panel of outside advisers to the agency that said American lives are at risk because the FDA lacks the funding to keep up with scientific advances.

"Americans depend on the FDA to ensure the safety and effectiveness of medical products, including medical devices, manufactured throughout the world," Crosse said in prepared testimony. "However, our findings regarding inspections of medical device manufacturers indicate weaknesses that mirror those presented in our November 2007 testimony regarding inspections of foreign drug manufacturers."

Bloomberg

[NYC]

5. Hospital: Avoid Chinese Company's Products.

http://www.stripes.com/article.asp?section=104&article=52143

The U.S. Naval Hospital here issued a warning Friday night that all products made by the Chinese manufacturer are suspected of containing traces of the pesticide.

“The frozen gyoza which caused illness in the initial case was imported by JT Foods, but all the products were made at a single factory in China, Hebei Foodstuffs Import & Export Group, Tianyang Food Processing,” the hospital’s press release says.