Democrats blast FDA in heparin case

When federal regulators failed to inspect a Chinese factory at the center of a massive drug recall, they didn't break any laws.

That legal vacuum has members of Congress asking if laws are needed to make sure the Food and Drug Administration follows its own regulations for inspecting foreign facilities.

Reps. John Dingell and Bart Stupak blasted the agency in a letter Thursday for failing to inspect a Chinese facility that supplied the main ingredient for Baxter International's heparin.

Deerfield-based Baxter recalled thousands of vials of the blood thinner and halted production earlier this month after it was linked to four deaths and hundreds of allergic reactions. FDA officials said Monday the Chinese plant was not inspected because it was confused with a different company with a similar name. The agency has sent inspectors to China to determine if the factory is the source of the problems.

But the Michigan Democrats said under FDA's own guidelines, agency officials should have inspected the plant before any shipments entered the U.S. The regulation has been in place more than 20 years, though neither companies nor FDA are required by law to conduct pre-shipment inspections.

"Since it appears that FDA feels free to ignore this long-standing policy, we are now considering whether such a safeguard should be codified into law," said Dingell in a statement. He chairs the House Energy and Commerce Committee which oversees FDA.

Government watchdogs have reported that FDA annually inspects 7 percent of drug makers exporting to the U.S., according to the Government Accountability Office. That means more than 13 years can pass before a foreign manufacturer is visited even once.

The lawmakers sent a separate letter to Baxter Thursday, questioning whether the company knew FDA hadn't inspected the source of its drug's ingredient. The letter asks the company to turn over all correspondence with FDA about the plant.

"Was your firm misled by FDA into believing that the Chinese firm was an approved supplier?" the lawmakers ask in the letter. "If not, then we are concerned that your company was knowingly distributing an unapproved drug."

Baxter spokeswoman Erin Gardiner said Thursday the company has followed all legal and regulatory requirements needed to import the ingredient. Baxter officials inspected the facility last year, Gardiner said, and plans to visit the site again as part of its own probe.