US FDA prescription drug inspections questioned

[Guest guest]

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. 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 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, 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

[Guest guest]

Tainted pills hit U.S. mainland

By MICHAEL MELIA, Associated Press Writer 33 minutes ago

SAN JUAN, Puerto Rico - The first warning sign came when a sharp-eyed

worker sorting pills noticed that the odd blue flecks dotting the

finished drug capsules matched the paint on the factory doors...

Flu/message/8443

> why do they have to inspect the plants ?

> Inspect the produced drugs instead.

[Guest guest]

Yes, the drugs must be inspected. On the other hand, it is in the manufacturing plants where the contamination happens or where there is little or not quality control.sterten@... wrote: why do they have to inspect the plants ? Inspect the produced drugs instead. . Do one thing every day that scares you. Eleanor Roosevelt