http://www.***.com/
Foreign drugmakers escape FDA scrutiny
Two-thirds of companies never visited by government inspectors

Sunday, Nov. 18, 2007

WASHINGTON - Two-thirds of the foreign drug manufacturers subject to
inspection by the cooking.net">food and Drug Administration may never have been visited
by agency inspectors, a government watchdog reported to Congress Thursday.

The FDA this year listed 3,249 foreign pharmaceutical manufacturers
subject to its inspection yet the agency cannot determine whether it has
ever inspected 2,133 of them, according to a Government Accountability
Office report released during a House subcommittee hearing.

While some of the more than 3,000 firms may never have exported
prescription {*filter*} or drug ingredients to the United States, others likely
have.
Story continues below ?adverti{*filter*}t

Who are those firms and what are they shipping? asked Rep. Bart Stupak,
D-Mich., during Thursday's hearing of the House Energy and Commerce
subcommittee on oversight and investigations.

"We don't know and we are not certain the FDA knows," Marcia Crosse,
director of health care at the GAO, replied.

The few foreign inspections the FDA does conduct in any given year hit
just 7 percent of the foreign drug makers exporting to the U.S., the GAO
estimates. That means more than 13 years can pass before a foreign
manufacturer is visited even once, Crosse said.

In the case of China, which with 714 drug firms boasts the largest number
subject to FDA scrutiny of any country, the record is far worse. The FDA
is slated to inspect just 13 Chinese establishments this year, meaning
just 1.8 percent will see an FDA inspector, according to the GAO report.

In India, the No. 2 country, the record is far better. There, 65 of its
410 firms, or 15.8 percent, are slated for inspection this year, according
to the GAO. That's in line with the 16.8 percent of Swiss drug firms the
FDA likely will inspect in 2007.

The GAO and Congress have long warned of the FDA's shortcomings in its
foreign drug inspection program. The GAO findings released Thursday
largely reprise many of the same warnings outlined in a 1998 report.

'Deja vu all over again'
"It's deja vu all over again," said Rep. John Dingell, D-Mich.

Nearly all U.S. drug makers are inspected at least once every two years,
as mandated by a law drawn up long before imports seized a sizable chunk
of the drug market. There is no such requirement that the FDA conduct
foreign inspections with any regularity, even as imports of all kinds grow
in volume. Concerns about the safety of imported {*filter*}, food, toys and
other consumer products have been at the fore for months.

"We're finding ourselves again on the brink of one more problem dealing
with imports into our country," said Rep. Michael Burgess, R-Texas, adding
that current FDA laws and regulations were never intended to handle the
increasing volume of imports.

An estimated 80 percent of the active pharmaceutical ingredients used to
make {*filter*} sold in the U.S. are imported. Among finished {*filter*}, an
estimated 40 percent are made abroad.

The FDA plans to inspect just 300 foreign drug firms this year, announcing
in advance its intent to do so each time. That can hinder the FDA's
ability to view normal, day-to-day operations, the GAO found. Further, FDA
inspectors aren't provided with translators, leaving them to rely on
English-speaking firm employees.

Of those foreign inspections, 88 percent are of firms that make {*filter*}
awaiting FDA approval, according to the GAO. The balance are of the type
of periodic assessment meant to ensure a company's products remain safe in
the years following FDA approval. Within the U.S., the proportion is
flipped, with 78 percent of FDA drug inspections of the routine,
surveillance variety.

The head of the FDA, meanwhile, said the issue is larger than just one of
inspection numbers.

"The solution to ensuring the quality of imports does not rely solely on
increasing the number of inspections we conduct abroad or even at the
border," Dr. Andrew von Eschenbach said, adding that the FDA seeks to
revamp its whole import strategy to focus on ensuring quality is built
into agency-regulated products from the start. He also proposed posting
FDA employees abroad, where they could help build up the agency's foreign
counterparts.

When FDA does visit foreign plants, its inspectors can make sometimes
harrowing findings. A warning letter released Thursday by the FDA cited a
Chinese manufacturer of pharmaceutical ingredients for a litany of
problems, including rust, flaking paint and holes in the ceiling of the
production area for an unnamed product.

Much of the uncertainty in the FDA's handling of foreign drug makers stems
from its outdated computer systems, which rely on multiple databases that
contain sometimes conflicting information that can be compared only
manually, the GAO found. Those databases, for instance, contain tallies of
foreign drug firms subject to FDA inspection that range from roughly 3,000
to about 6,800, the GAO found.

Crisis of confidence
"How can we have any confidence FDA is truly managing the risk that may
come from foreign-made drug products if the FDA doesn't know the exact
number or location of foreign drug manufacturers," Stupak said.

Some clarity should be forthcoming: The FDA is soliciting bids to have its
worldwide registration database verified, said Margaret Glavin, the FDA's
associate commissioner for regulatory affairs.

Von Eschenbach acknowledged his agency's computer infrastructure remains a
problem. Still, he said the U.S. drug supply is among the world's safest.

"We shouldn't leave people with the impression the drug supply is unsafe,"
said William Hubbard, a former FDA associate commissioner.

"It's vulnerable," interjected Rep. Greg Walden, R-Ore., finishing his
sentence.