WASHINGTON – U.S. Rep. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, today pressed the Government Accountability Office for a thorough review of the Food and Drug Administration’s handling of the heparin issue.
One concern is related to FDA’s classification of the deaths of three patients. According to a Chicago Tribune article, the FDA “conclusively linked” the deaths of the patients to a foreign substance found in specific lots of the pharmaceutical company Baxter’s blood-thinning drug. However, in an Oct. 23, 2008, response to Barton, the FDA said that “with regard to the three death reports, FDA classified the cause of death from heparin as only ‘possible’ in two of those cases, and ‘unassessable’ in the third case.”
FDA’s Adverse Event Reporting System casts doubt on heparin as a “possible” cause of death in one case.
Barton’s letter to GAO also questions whether FDA used all of the tools available to conduct comprehensive surveillance of the heparin deaths. “FDA confirmed to the committee’s Republican staff that the agency did not follow up to interview clinical staff or Baxter for further details about each of these cases,” the letter says. “In addition, FDA told staff the agency did not access other databases, even though FDA has testified that such databases enhance FDA’s ability to evaluate drug safety problems.”
“I am particularly concerned because of the high profile of heparin safety and the international attention to FDA’s analysis concerning heparin deaths,” Barton wrote. “The Chinese government has openly questioned FDA’s heparin investigation and whether the identified contaminant in heparin is actually a dispositive factor in causing death. Heparin safety is not only a public health concern in the U.S. but in the rest of the world.
“My hope is that the GAO’s review will determine the strengths and weaknesses in FDA’s response to the heparin drug safety problem, and will make recommendations on what the FDA could do better in dealing real-time with an emerging drug safety problem in the future,” Barton added.
A copy of the letter can be found here.
