FWIW: FDA confused?

Wes Bucey

Prophet of Profit
So, For What It's Worth: The FDA seems unable to find its way in China and were too proud to ask directions. Talk about the left hand not knowing what the right hand is doing:bonk:
Washington Post said:
FDA Says It Approved The Wrong Drug Plant
Heparin Probe Sends Inspectors to China
By Marc Kaufman
Washington Post Staff Writer
Tuesday, February 19, 2008; A01

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.

Millions of people each year are given the drug during dialysis or to prevent complications from surgery, but the FDA has never checked the Chinese plant where the active ingredient is made. The agency and Baxter are investigating whether anomalies in the ingredients from China could have caused the dangerous reactions in some patients.

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.

In a letter to the FDA last week, for example, Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, said that the heparin situation illustrates the "disastrous state of your agency's foreign inspection program related to pharmaceuticals manufactured abroad."

Dingell noted that the agency seems uncertain even of the number of foreign drugmakers, with one database saying there are 7,000 while another counts 3,000.

Widespread criticism of the FDA's work -- and pressure to change -- followed last year's discovery of tainted pet food from China, as well as lead paint on some toys and barely regulated drugs.

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. He also requested that the State Department approve a permanent FDA presence at the U.S. Embassy in Beijing and two American consulates in China.

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

The American market for the generic drug heparin is shared by Baxter and APP Pharmaceuticals. Baxter gets its product from Scientific Protein Laboratories, a Wisconsin-based company that finishes the drug both in the United States and in China, according to Baxter spokeswoman Erin Gardiner. Baxter sells 35 million vials of heparin a year, she said.

The active ingredient used by Baxter and APP is derived from an enzyme found in pig intestines and is made solely in China. But the reported problems have involved only Baxter's version of the drug, which uses an active ingredient from a manufacturing plant started by the Wisconsin firm called Changzhou SPL, west of Shanghai. It was opened in 2004.

According to the FDA, that plant has not been inspected by Chinese drug regulators, who sometimes do not visit facilities manufacturing for foreign markets. Baxter has said that it had sent its own representatives there to ensure proper manufacturing procedures were being followed six months ago.

Gardiner said that the company has detected slight variations between different lots coming from China.

When the application from the Changzhou firm was activated, Famulare said, it was mistaken for another Chinese firm that made a different drug. The FDA accepts previous positive inspections as sufficient proof that a company is doing a good job, and it can approve new drugs or drug ingredients based on that record.
Kind of gives new meaning into the derogatory term "Chinese Fire Drill" doesn't it?
 
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Sidney Vianna

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https://www.qualitydigest.com/currentmag/news.shtml#5

NOTE added: The above link is a 'relative' url and will expire within a month.

We are greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme,” says Robert Parkinson, CEO of Deerfield, Illinois-based Baxter International Inc., during a congressional hearing on April 29. “The developments of the last several weeks have demonstrated that this is both a global and industrywide crisis, with a root cause--oversulfated chondroitin sulfate--that was so novel and so insidious as to avoid the quality systems of a multitude of companies and the oversight of the world’s most sophisticated drug regulatory agencies.”

At the same hearing, reported by the Chicago Tribune on April 30, David Strunce, chief executive of Wisconsin-based Scientific Protein Laboratories LLC (SPL), the supplier of the materials used to make Baxter’s heparin, admitted that the company has no way of tracking which of 12 different suppliers might have introduced contamination into the heparin supply chain.

SPL operated the now-closed plant in Changzhou, China, that obtains the raw material for heparin, which is derived from pig intestines, by purchasing bulk materials from village workshops and rural pig lots in China. Strunce claims that Chinese regulators have interfered with his company’s efforts to determine the source of the contaminating material. Oversulfated chondroitin sulfate is a more cheaply produced derivative of cartilage and is not a naturally occurring compound. The hypersulfated version is a very heparin-like molecule.

Compounding SPL’s alleged difficulties with tracking the source of the contamination was the fact that five months prior to the Food and Drug Administration (FDA) conducting a five-day inspection of the Changzhou SPL Co., and subsequently reporting myriad procedural and quality violations, a Baxter representative had given the plant a one-day “snapshot” inspection and passed it as a safe source of material for Baxter.
All of this tragic rigmarole begs the questions: How can U.S. medical manufacturers be sure that their imported ingredients meet quality and safety standards, who should be responsible for verifying that quality and safety, and how far down the supply chain should quality auditors be obligated to go when verifying the quality of basic ingredients?

Ideally, one would expect any company to run rigorous tests of all raw materials before using them and to apply the same rigor in testing its finished products before releasing them to an unsuspecting public.
As Richard L. Friedman, director, FDA Center for Drug Evaluation and Research wrote to the Changzhou SPL Co. in response to its March 17, 2008 response to the FDA’s February report on the company’s many safety and quality violations: “The mere fact that it is difficult to isolate and identify impurities is insufficient rationale for not establishing appropriate specifications for, and routinely monitoring, impurities during production.”
 
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