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Baxter Heparin Problems Linked to FDA Mix-up

Feb 19, 2008 | Parker Waichman LLP The Baxter Heparin scandal is putting the Food & Drug Administration (FDA) in a bad light.  Last week, it was learned that the FDA had never inspected the Chinese facility that supplies the active ingredient for Baxter Heparin.  Now the FDA has conceded that the Baxter Heparin supplier was never inspected because the agency confused it with another facility. The FDA said that a team of inspectors is now headed to China to review the correct plant to determine what may have caused serious problems with Heparin. Unfortunately, the FDA’s attempt to correct this mix up has come too late to the hundreds of US patients who have fallen ill as a result of Baxter’s tainted heparin.

Heparin is a blood thinner administered in surgery and other critical care areas to prevent clots, is crucial in dialysis and heart surgery, and is used for the bedridden.  Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S.  The FDA reported that, since the end of 2007, it received about 350 reports of health problems associated with Baxter's multiple-dose injectable heparin; 40 percent were deemed serious.  Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in four cases, death.  Baxter stopped selling multiple-dose Heparin vials earlier this month and the FDA has advised doctors to prescribe alternatives.

Joseph Famulare, deputy director for compliance at the FDA's center for drug evaluation and research, said that when the company that makes the active ingredient for heparin applied for FDA approval, the FDA believed the application came from another company with a similar name that had been inspected.  "To date, this is an isolated situation, but the wrong firm was put into the database," he said.  Famulare would not name the Chinese company approved in error.  FDA officials said that although federal law does not require inspections of foreign drug makers, the agency will generally inspect before a new foreign drug, or foreign active drug ingredient, is allowed in an FDA-approved prescription medication.  That inspection need not include an on-site visit if the foreign company passed previous inspections for other drugs.

The Government Accountability Office and some members of Congress have concluded that the FDA lacks the resources to inspect thousands of imported drugs and drug ingredients, particularly those from India and China.  Representative John D. Dingell (D-Michigan), chairman of the House Energy and Commerce Committee, said to the FDA in a letter that the Heparin situation illustrates the "disastrous state of your agency's foreign inspection program related to pharmaceuticals manufactured abroad."  Dingell noted the FDA seems unclear about the actual number of foreign drug makers:  One database states 7,000, another 3,000.  In response, FDA Commissioner Andrew C. von Eschenbach proposed basing FDA inspectors and technical advisers in China, India, the Middle East, and three other regions and requested the State Department approve a permanent FDA presence at the U.S. Embassy in Beijing and two American consulates in China.

Michael Rogers, director of field investigations for the FDA’s Office of Regulatory Affairs, said that the Heparin investigation is "one of the agency's top priorities" and that inspectors will remain in China until they determine whether health problems associated with Heparin originated there.  He said the FDA is unsure about the "root cause" of the adverse reactions.

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