My Dragon's Lair Sharing is the reason for my being...: FDA has not been inspecting foreign drug firms, watchdog finds

WASHINGTON - Two-thirds of the foreign drug manufacturers subject to inspection by the Food and Drug Administration may never have been visited by agency inspectors, a government watchdog reported to Congress on 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 drugs or drug ingredients to the United States, others likely have.

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.

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

Most 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 drugs, 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.

An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the U.S. are imported. Among finished drugs, an estimated 40 percent are made abroad. By ANDREW BRIDGES The Associated Press November 2, 2007 More articles