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Texas Congressman to GAO: FDA Needs to Improve Its Drug Safety System

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From CNN: WASHINGTON -(Dow Jones)- Rep.

Joe Barton, R-Texas, on Thursday raised questions about the adequacy of the Food and Drug Administration’s handling of a scandal involving a contaminated blood thinner amid concerns the agency misreported deaths tied to the product and didn’t thoroughly investigate the problem.

At issue are what appear to be conflicting statements the FDA made to the public and Congress about the number of deaths tied to contaminated batches of heparin, a widely used blood thinner for cardiac surgery.

In May, the FDA said it completed a review and linked three deaths to contaminated heparin. Last month, the FDA told congressional staff that only two of the deaths were possibly linked to contaminated heparin, while one was " unassessable," according to a letter Rep. Barton sent Wednesday to the Government Accountability Office, the investigative arm of Congress. Rep. Barton is also ranking member of the powerful House Energy and Commerce Committee.

But a company involved in the heparin scandal, Baxter International Inc. (BAX), did its own investigation of the deaths and concluded the blood thinner likely wasn’t the cause in the three cases, according to the letter. Baxter’s investigation included obtaining medical records from the patients, interviewing pharmacists and nurses, and visiting a hospital where one of the patients had gone before dying.

The FDA didn’t follow up with clinical staff at the hospitals or talk with Baxter to find out further information about the deaths. The FDA also didn’t access other medical databases it acknowledges enhance its ability to evaluate drug safety problems.

Based on this information "there is a serious and potentially troubling question about whether FDA availed itself of all of its tools to conduct comprehensive surveillance of heparin deaths," Rep. Barton said in the letter.

The FDA began investigating heparin earlier this year after receiving hundreds of reports of allergic reactions and dozens of deaths in patients who had taken the blood thinner, which is essential during procedures like cardiac surgery. Contaminated heparin from China was eventually found in batches of the blood thinner owned by Baxter.