WASHINGTON – U.S. Reps. Joe Barton, R-Texas, ranking member on the House Energy and Commerce Committee, and Michael Burgess, R-Texas, ranking member of the Oversight and Investigations Subcommittee, today revealed new information related to the heparin contamination investigation and asked the Food and Drug Administration commissioner to answer questions on the agency’s handling of the investigation of heparin contamination. The FDA has linked the heparin contamination to deaths and allergic-type reactions.
Committee investigators have uncovered information that warrants further review of Chongqing Imperial for direct involvement in, or knowledge about, the contamination of heparin. A string of FDA internal documents show that Chongqing-produced heparin was involved in a number of different supply chains that had contaminated lots.
The case, which remains unsolved, has been troubled since the problems first surfaced in 2008. The lawmakers’ main concerns, as laid out in the letter to Commissioner Margaret Hamburg, are:
1. “FDA has not adequately followed up on specific and credible information linking Chinese heparin firms to counterfeit heparin or contaminated heparin in several different supply chains.
2. “FDA inspected several Chinese heparin firms in 2008 and 2009 for regulatory compliance issues, but did not conduct these inspections consistently and adequately for determining the source of the heparin contamination.
3. “FDA has not adequately followed up with the Chinese government about the heparin contamination-source investigation.”
Barton and Burgess have asked Hamburg to answer the following questions:
1. What is FDA’s strategy for solving the question of who caused the contamination of the heparin supply? Please detail the strategy and when it was developed, the names and positions of the FDA officials who developed the strategy, and the names and positions of the FDA officials responsible for implementing the strategy.
2. To what extent can FDA conduct a traceability investigation of various heparin supply chains in China on its own without the assistance of the Chinese government?
3. Assuming FDA could solve the case on its own, what would FDA do with this information?
4. What actions is FDA taking to follow up on the Chongqing Imperial issues raised in this letter?
5. Does the FDA agree there is a basis to make another request to the Chinese government about the heparin contamination investigation? If not, why not?
6. Is the FDA willing to cooperate and even share information with the Chinese government in an effort to solve the heparin contamination case? Would FDA be able to do this under current law and under the current agreement with the SFDA? If not, why not?
7. Does FDA agree that the contamination of the heparin supply is an international issue? If so, why hasn’t the FDA sought international support from the World Health Organization and/or other countries to get more transparency and cooperation from the Chinese government, or to provide assistance to the Chinese government, in the heparin contamination-source investigation?
A link to the letter can be found here.