Your ever vigilant and forthright Food and Drug Administration, which
claims to be overworked and understaffed, is unable to safeguard your
White House war criminals' still duped supporters from bad and fake
drugs from our good and honest friends in China and India. That means
that even Bush's bashers aren't immune from hazardous imports.
But things are unlikely to get better soon. And what's the NEXT BIG
FEAR to descend upon the U.S.?
SARS? Salmonella? Dead dogs and cats?
How about polonium-210?
------------------------------------------
"FDA Scrutiny Scant In India, China as Drugs Pour Into U.S.
Broad Overseas Checks Called Too Costly"
By Marc Kaufman
Washington Post Staff Writer
Sunday, June 17, 2007; A01
India and China, countries where the Food and Drug Administration
rarely conducts quality-control inspections, have become major
suppliers of low-cost drugs and drug ingredients to American
consumers. Analysts say their products are becoming pervasive in the
generic and over-the-counter marketplace.
Over the past seven years, amid explosive growth in imports from India
and China, the FDA conducted only about 200 inspections of plants in
those countries, and a few were the kind that U.S. firms face
regularly to ensure that the drugs they make are of high quality.
The agency, which is responsible for ensuring the safety of drugs for
Americans wherever they are manufactured, made 1,222 of these quality-
assurance inspections in the United States last year. In India, which
has more plants making drugs and drug ingredients for American
consumers than any other foreign nation, it conducted a handful.
Companies based in India were bit players in the American drug market
10 years ago, selling just eight generic drugs here. Today, almost 350
varieties and strengths of antidepressants, heart medicines,
antibiotics and other drugs purchased by American consumers are made
by Indian manufacturers.
Five years ago, Chinese drugmakers exported about $300 million worth
of products to the United States. Eager to meet Americans' demand for
lower-cost medicines, they, too, have expanded rapidly. Last year,
they sold more than $675 million in pharmaceutical ingredients and
products in the U.S. market.
After the pet food scandal that triggered fears over the safety of
human and animal foods imported from China, experts say medicines from
that country and from India pose a similar risk of being contaminated,
counterfeit or simply understrength and ineffective.
"As the manufacturing goes to China and India, the risk to human
health is growing exponentially," said Brant Zell, past chairman of
the Bulk Pharmaceuticals Task Force. The group represents American
drug-ingredient makers that filed a citizen's petition with the FDA
last year asking the agency to oversee foreign firms more
aggressively.
"The low level there" of follow-up inspections, "combined with the
huge amount of importing, greatly increases the potential that
consumers will get products that have impurities or ineffective
ingredients," he said.
FDA officials say that they are not aware of any health problems
caused by drugs imported from India or China and that the American
companies that import them usually do their own quality and safety
testing. But the agency acknowledges that it is virtually impossible
for it to know whether poor-quality or contaminated drugs from lightly
regulated Asian plants have caused patients to get sicker or remain
ill, especially because patients and doctors are unlikely to suspect
poorly manufactured drugs as a problem.
What is clear is that the odds are growing rapidly that the contents
of an American medicine cabinet will hold products from the two
countries.
Analysts estimate that as much as 20 percent of finished generic and
over-the-counter drugs, and more than 40 percent of the active
ingredients for pills made here, come from India and China. Within 15
years, they predict, as much as 80 percent of the key ingredients will
come from those countries -- which are quickly becoming attractive to
brand-name drugmakers, too.
William Hubbard, a former FDA associate commissioner, called the
situation dire and deteriorating.
"You have this confluence of events, with so much more product coming
from abroad and fewer and fewer inspections," Hubbard said. "This is
very serious stuff, because a contaminated drug hitting the market
could cause lots of injuries or worse before it got tracked down."
He also said that the FDA inspection system is so weak that many
foreign manufacturers believe they "can play games without
consequences."
[Read all ...
http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR20070616011295
.html?hpid=moreheadlines
sandman - 18 Jun 2007 01:59 GMT
I understand that the Bush WH gets it's produce flown in from Europe which
has strict regs, and to these purchases follow them when traveling. That
means they're not eating the engineered stuff, either.
> Your ever vigilant and forthright Food and Drug Administration, which
> claims to be overworked and understaffed, is unable to safeguard your
[quoted text clipped - 99 lines]
>
> http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR20070616011295
.html?hpid=moreheadlines