Forget appealing to the U.S.'s Nincompoop-In-Chief and his FDA and
other consumer safety watchdogs.
Anything involving BIG BUSINESS and BIG COUNTRIES is hands-off insofar
as criticism or sanctions are concerned.   (How's that stimulus
package coming?)

But ask your selves if you are confident that those generic
prescription drugs or vitamins from CHINA contain what you hope or
expect them to contain. Or not contain.

Thank goodness that some members of your deservedly-maligned U.S.
Congress are attempting to ask the right questions about imported
drugs and other products of doubtful purity or genuineness that are
shipped by the millions to U.S. markets and consumers every day.

-------------
"Safety of Drug Imports Questioned"

"Some in Congress Want FDA to Expand Overseas Inspections"

By Marc Kaufman
Washington Post Staff Writer
Thursday, February 7, 2008; A19

With an ever-larger percentage of prescription drugs and drug
ingredients coming to the U.S. market from developing nations such as
China and India, Congress is voicing concern that the number of
inspections of those plants by the Food and Drug Administration has
grown far more slowly.

In a Feb. 1 letter to the FDA, Sen. Charles E. Grassley (R-Iowa) said
that the small number of inspections in these newer markets is putting
consumers at risk.

In particular, he wrote, he was concerned that the number of
inspections in China -- a major supplier of active drug ingredients --
is small and actually dropped from 18 in 2004 to 11 in 2007. China is
believed to have hundreds, if not thousands, of plants that make
ingredients for drugs headed to the United States.

"I found these numbers very troubling," Grassley wrote. "Since the
beginning of FY 2002, the FDA conducted approximately 1,379
inspections of foreign pharmaceutical facilities, often focused in
countries with few reported quality concerns."

Other lawmakers and outside experts are worried that drugs from low-
cost producers in India, China and elsewhere are not receiving the FDA
scrutiny they require. Grassley's staff asked the FDA last year if it
is planning to open an office in India.

In December, the agency said it was considering a new office only in
China. Last month, however, FDA Commissioner Andrew C. von Eschenbach
told reporters that he was working on a plan to station inspectors in
six regions abroad so they can inspect plants on an "ongoing and
continuous basis rather than episodic and periodic."

According to the statistics provided to Grassley, even that kind of
inspection does not happen very often. And an overwhelming number of
inspections are conducted in nations such as Germany, Switzerland,
Italy and Canada rather than in countries with much weaker drug
inspection programs of their own.

This is largely because the FDA can allocate "user fees" provided by
brand-name drug companies to pay for inspections of their plants, many
of which are in Europe. The agency does not have nearly as much money
to pay for inspections for low-cost generic drugs because those
manufacturers do not pay such fees.

Grassley said in his letter that "this seems to be a misplacement of
limited FDA resources."

The FDA says that consumers still can be confident in the quality of
the drugs they take. The agency says it has required improvements in
the entire drug manufacturing process and does not rely entirely on
inspections.

Responding to an October letter from Grassley's staff, Stephen R.
Mason, the FDA's acting commissioner for legislation, said it cost the
agency $6.2 million in fiscal 2007 to pay for about 300 foreign drug
inspections.

The Bush administration has proposed a budget increase of 5.7 percent
for the FDA, with additional money for foreign inspections, especially
of food.

But critics said those funds will barely keep up with scheduled pay
raises. A panel of outside experts told Congress last fall that the
agency needs to double its budget if it hopes to keep drugs and food
for Americans safe.

The Government Accountability Office reported last year that the FDA
does not know how many foreign plants are manufacturing products for
the American drug market, and is unaware whether they are being
inspected effectively.

In response, Sens. Byron L. Dorgan (D-N.D.) and Olympia J. Snowe (R-
Maine) sent letters to the heads of 10 major drug companies asking
them for information on how many of their products are manufactured
abroad, and where. Dorgan spokesman Barry Piatt said that nine of the
10 companies have sent in responses.

http://www.washingtonpost.com/wp-dyn/content/article/2008/02/06/AR2008020604445.html