China does not inspect drugs for export.

GOOD MORNING FLINT ! Early edition
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Date 2/19/08
By Terry Bankert
http://attorneybankert.com/
Posted full article first to Flint Talk THEN summarized, for discussion, at
http://flinttalk.com/viewtopic.php?p=25126#25126
Full article at Google blog Good Morning Flint!
http://goodmorningflint.blogspot.com/ with citations.
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My daily bloggs , as here, are often just my curiosity peaked by what I see in the news. Here my question is : How can we continue to allow China to import into the United States? I look for 4 sources and spend no more than 2 hours. I hope you find it interesting, I learned .[trb]
______________________

Mix-Up Blamed for FDA Failure on China Heparin Plant [B]

No Export Regulation, free market ,thinner, and death?[trb]

Agency error means facility linked to fatal lots of injected heparin was ignored, officials say[US]

I do not know about you but I expect my president and congress to protect me from pharmaceutical imports that can kill me or my loved ones. Congress let us down in the China import scandals. How many more American have to die before we stop Chinese Imports?[trb]

Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a "bolus dose," which is a high dose administered over a short period of time, according to the FDA.[US]

Our government has known about the China problem for years.[trb]

A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews. [NYT]

These problems were exposed " against the backdrop of incidents in which Chinese-made drugs caused illness and death around the world."[CT]

HEPARIN

U.S. regulators didn't inspect a Chinese plant that makes an ingredient tied to life-threatening side effects with the blood-thinner heparin because they mixed up records on that facility and another with a similar name. [B]

Last week, the FDA told physicians to stop using Baxter's heparin, citing 350 reports of side effects so far this year. [A]

THE FDA KNEW IN 2007

In 2007, the agency (FDA) received 100 reports of problems with the drug. Baxter said it would stop manufacturing multiple-dose vials while it and FDA attempts to locate the source of the problems.[A]

IS THERE ANY SAFETY IN CHINESE MFG FIRST TOYS NOW DRUGS!

The safety of Chinese factories has raised concerns about whether U.S. government agencies are doing enough to inspect Chinese-made products and protect American consumers. The Consumer Product Safety Commission was criticized last year for not aggressively taking lead-tainted toys off the market, and now the FDA is coming into the spotlight.[CT]

PEOPLE ARE DYING AND THE FDA IS NOT SURE WHY!

Michael Rogers, director of FDA's Division of Field Investigations in the Office of Regulatory Affairs, is spearheading the investigation. He told reporters that the agency is uncertain as to what is causing the adverse events linked to use of the injected heparin.[US]
Agency error means facility linked to fatal lots of injected heparin was ignored, officials say[US]

GOOD INSPECTION WRONG PLANT

Regulators mistakenly referred to inspection records for a plant from another company and cleared the heparin facility without necessary inspections and evaluations, said Joseph Famulare, deputy director at the Food and Drug Administration's Center for Drug Evaluation and Research.[B]

BAXTER PLANT NOT INSPECTED FAILS..BUT THEY WILL GET RIGHT ON IT.

The FDA will begin inspecting the plant this week, the agency said today in a conference call with reporters. On Feb. 11, the FDA said use of heparin in multi-dose vials made by Deerfield, Illinois-based Baxter International Inc., had been tied to dangerously low blood pressure, vomiting and difficulty breathing. Four patients taking the drug died, the agency said. [B]

QUALITY PROBLEMS IN CHINA, DO YOU THINK!

China's drug industry has quality problems. When the Chinese State Food and Drug Administration does process new-drug applications, it rejects nearly one in four, according to a report by investment bank Credit Suisse.[ct]

SHELF CHEMICAL PRODUCER TESTS AS GOOD AS PHARMACEUTICAL

A spokesman for China's State Food and Drug Administration told The New York Times on Friday that the FDA-inspected plant was not a drug manufacturer but "a producer of chemical ingredients" and not licensed to make pharmaceutical products.[US]

A VERITABLE REGULATORY VOID

The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close — in which chemical companies export pharmaceutical ingredients without a Chinese drug license. [NYT]


DID YOU KNOW CHINESE DRUGS HAVE KILLED OVER A 100 PEOPLE SINCE 2006, CONGRESS SHOULD HAVE.

The emphasis on China's market has been called into question by a recent run of tainted drugs outside China's borders. Since 2006, tainted Chinese drugs have been blamed for more than 100 deaths in Panama, central America and the Caribbean.[CT]

ONE BAD VENDOR SHOULD NOT HURT BAXTER?

``To date this is an isolated situation, but the wrong firm was put into database, therefore this one was not evaluated or scheduled for inspection,'' Famulare, who works with the FDA centers' compliance office, said on the call today. ``We're acting upon that by doing our immediate inspection. We're looking at this process, and we have not found any other firms in this category.'' [B]

DID YOU KNOW DRUG PRODUCTION FOR WORLDWIDE DISTRIBUTION IS BIG IN CHINA

China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction[NYT]

THIS HAS BEEN KNOWN FOR ONE YEAR ,REACTIONS IN DIALYSIS

Baxter makes roughly half of the United States supply of heparin, which is used widely for surgical and dialysis patients. Problems with Baxter’s heparin were first noticed late last year when four children undergoing dialysis in Missouri had severe allergic reactions minutes after being injected with the drug. [NYT]

BAXTER HAS ONE HALF THE MARKET! ISOLATED?

Authorities are urging doctors to use non-Baxter vials of heparin. Baxter, which had about half the U.S. market, agreed last week to temporarily halt making heparin in multiple-dose vials associated with the side effects. Used by millions of people, heparin generates about $30 million in annual sales for Baxter, which reported $11.3 billion in revenue for 2007. [B]

APP Product Unaffected ...

APP Pharmaceuticals Inc., based in Schaumburg, Illinois, has the other half of the U.S. market for heparin sold in vials. APP's supplier in China has passed inspections, and its vials haven't been linked to the same adverse reactions, FDA said. [B]

SINCE PEOPLE ARE DYING ITS NOW A HIGH PRIORITY.

``We don't know what is causing these adverse events,'' said Michael Rogers, director of the FDA's Division of Field Investigations, during the call. ``The agency considers this as one of its top priorities and is dedicating all appropriate resources to this investigation.'' [B]

ONE MISSED PLANT, 93% NOT EVEN TESTED!

The product-quality troubles have raised questions about the ability of Chinese regulators to protect consumers amid major growth of China's drug industry.[CT]

Bart Stupak, a Democratic representative from Michigan, last week criticized the FDA for failing to inspect the plant in China. The agency conducts annual inspections of about 7 percent of overseas drugmakers that ship to the U.S., a pattern suggesting the FDA would take 13 years to visit them all, according to the Government Accountability Office, the investigative arm of Congress. [B]

CONGRESS CRITICIZED

Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year.[NYT]

CHINA IS A TOP SUPPLIER, SHOULD THEY BE ALLOWED TO IMPORT INTO THE U.S.

Concerns over inspection standards in China's drug industry are particularly acute at a time when the country has emerged as the top supplier of active ingredients in pharmaceuticals. China also is making a big push into production of generic drugs, a market India has dominated.[CT]

ONE INSPECTION GOES A LONG WAY.

All suppliers of active drug ingredients shipping to the U.S. are required to be approved by the FDA by passing physical inspections and evaluations, Famulare said. If a foreign facility has recently passed an inspection, it's not always necessary to conduct another for a new application, he said.[B]

THE U.S. CONNECTION

Baxter gets the ingredient for heparin from Scientific Protein Laboratories Inc., a U.S. company that makes the product both in the U.S. and China, according to the FDA and Erin Gardiner, a spokeswoman for Baxter. [B]

A U.S. CORPORATION OUTSOURCED TO CHINA, POISON RETURNED.

Scientific Protein Laboratories of Waunakee has made the active ingredient in heparin at its plant in Waunakee for more than 30 years. Since 2004 it has also produced it at a plant in Changzhou, China. The ingredient is derived from pig intestines and sold as a powder.[WKBT]

A U.S. EQUITY FIRM SENDS OUR WORK TO Changzhou, China

The plant is located in Changzhou, China, about two hours drive west of Shanghai, Gardiner said in a telephone interview today. Waunakee, Wisconsin-based Scientific Protein was bought by New York-based private equity firm Arsenal Capital Partners LP from Wyeth in 2004. [B]

TWO U.S. PLANTS ARE BEING CHECKED

The FDA is also inspecting and investigating Baxter's Cherry Hill, New Jersey, facility, and Scientific Protein's plant in Waunakee, Rogers said. Baxter is also conducting its own inspections of its supplier's plants in China and the U.S., Baxter's Gardiner said today. [B]

Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.[US]

NOW THERE WILL BE A BLOOD THINNER SHORTAGE

It's not clear how long Baxter's production of injectable heparin will be stopped. The one thing that is clear is that the stoppage could lead to a shortage of heparin, which is used to prevent blood clots in such patients as those undergoing kidney dialysis and heart surgery, U.S. health officials said.[US]

``We continue to advise doctors and other health-care providers to seek alternative sources of heparin,'' said Karen Riley, an FDA spokeswoman, on today's call. ``If they cannot, they should be cautious when administering the Baxter product to their patients.'' [B]

WE HAVE BEEN NEGOTIATING.

In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.[NYT]

THE CHINESE DO NOT INSPECT EXPORTS

The Chinese equivalent of the Food and Drug Administration only inspects plants that produce drugs for its own citizens, creating a loophole that the U.S. government has just begun to address[CT].

Two Congressional committees have asked the Food and Drug Administration for more information about inspections of plants making the active ingredient of heparin.[NYT]

China's central government sent a message last year by executing the former head of the
nation's food-and-drug watchdog for accepting bribes to approve drugs.[CT]

By Terry Bankert
http://attorneybankert.com/

—where did this stuff come from---

[WKBT]
WKBT
http://wkbt.com/Global/story.asp?S=7881243

[A]
Associated Press
http://ap.google.com/article/ALeqM5jqm4C9oxV7LhuwKEsld3Wi6D-08QD8UT0JBO0

[CT]
chicagotribune.com
http://www.chicagotribune.com/features/lifestyle/health/chi-sat_bloodthinner_0216feb16,1,4910816.story

[B]
Bloomburg.com
http://www.bloomberg.com/apps/news?pid=20601080&sid=azFQiOAkFqsk&refer=asia

[US]
U.S. New and World Report
http://health.usnews.com/usnews/health/healthday/080218/mix-up-behind-fdas-failure-to-inspect-china-blood-thinner-plant.htm

[NYT]
The New York Times
http://www.nytimes.com/2008/02/16/us/16baxter.html?hp
[trb]
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