FDA Says It Approved The Wrong Drug Plant – Heparin Probe Sends Inspectors to China
(www.washingtonpost.com) By Marc Kaufman
“The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.
The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.
More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous lowering of blood pressure, breathing difficulties and vomiting. Four patients who took the drug died. One of its two manufacturers, Baxter International, stopped selling its multiple-dose vials of heparin earlier this month, and yesterday the FDA advised doctors to prescribe alternatives.”
Joseph Famulare, deputy director for compliance at the FDA’s center for drug evaluation and research, said yesterday in a conference call with reporters that when the company that makes the active ingredient for heparin applied for FDA approval, the FDA thought the application had come from a different company with a similar name that had already been inspected.
“To date this is an isolated situation, but the wrong firm was put into the database,” he said. Famulare declined to name the Chinese company approved by mistake.
FDA officials said that although federal law does not require inspections of foreign drugmakers, the agency will in most instances 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 has 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 coming from India and China.”
YOU THINK? We have been talking about medication problems for weeks…
This one is just getting worse!