The U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue. A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present. In its announcement, the Committee stated:
“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”
The committee cited a GAO report that was issued in October 2010 on the heparin response as faulting “some” of the FDA’s actions, notably “including the decision to continue allowing drugs to be imported from Chinese facilities that refused to allow inspections.”
That is truly ironic given the fact that last week, the U.S. House of Representatives voted to cut FDA spending by over $220 million – thereby undermining FDA’s ability to carry out such inspections.
In fact, the opening statement in the summary of findings of that GAO report gave FDA support:
In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.
In addition, there is significant question as to whether the Food Safety Modernization Act will be funded sufficiently to allow for the many types of inspections contained in its charge to the FDA.
It is certainly important in any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body.
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