The FDA may want to get tough with drugmakers that outsource production (see this), but how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation.

You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 (back story), and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there (background). Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger.

“It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Joe Barton, the top Republican on the House Energy and Commerce Committee, tells The Wall Street Journal. He and Mike Burgess, another Texas Republican who is the ranking member on the Subcommittee on Oversight & Investigations, blast the FDA for not pressing the Chinese or acting on info obtained over the past two years (see this). The probe, by the way, comes as FDA commish Margaret Hamburg prepares for her first trip to China.

An FDA spokeswoman tells the Journal that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.” In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

Barton says the FDA told members of Congress that China hasn’t had any breakthroughs in its investigation, which they said left the “misleading impression” that “there was some kind of open investigation.” In fact, Chinese security authorities told a US official in Beijing in June 2008, that China wasn’t investigating the heparin episode as a criminal or administrative matter, he tells the paper.

Yan Jiangying, a spokeswoman for China’s State Food and Drug Administration, tells the paper the accusations “not true.” The Chinese FDA “did a very thorough investigation, including very detailed inspection and testing, and surveys of enterprises as well. We signed an agreement with the FDA on drug safety in the end of 2007, and strengthened the monitoring of heparin.”