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彭博社对中国药业的言论负面感觉深重...警惕啊
http://www.msn.com/en-us/news/money/why-the-fda-is-worried-about-chinese-drugs-in-your-medicine-cabinet/ar-BBmy4I1
原文摘录如下
Why the FDA is worried about Chinese drugs in your medicinecabinet
Bloomberg
Bloomberg News - 3 days ago When FDA inspectors showed up at a Chinese companythat supplies key ingredients to two of the U.S.’s biggest drug companies, acurious thing happened. Afterlunch, they walked into a quality control lab on the second floor, where theysaw a worker pull what looked like a memory stick from a computer and put it inthe pocket of his lab coat. The inspectors asked to see what he’d taken. Andthen the man turned and ran. TheU.S. Food and Drug Administration inspectors at Zhejiang Hisun PharmaceuticalCo. never found out what the worker took from the computer, but they foundplenty of other things, according to agency documents describing problems at thecompany, obtained through a Freedom of Information Act request by Bloomberg.There was evidence that quality control staff deleted records of tests thatmight show a drug was impure. Audit trails disappeared. A paper shredder waskept close by machines that recorded quality data. TheU.S. and the rest of the world are more dependent than ever on China formedicine. Along with India, the country is one of the top two producers of baseingredients for drugs in the world, according to the Institute of Medicine, andthe FDA has made inspections there a priority to keep patients safe. It’s foundplenty -- the agency has barred 38 plants in China from exporting some or allof their products to the U.S. for manufacturing violations. And 34 facilitiesare banned from exporting a blood thinning ingredient, after a past scandal,according to the FDA’s import alert list. Banned Imports Amongthose Chinese manufacturers, Hisun is one of the largest and makes keycomponents of everything from cholesterol to cancer medicines. Its U.S.customers include companies such as Hospira Inc., now owned by Pfizer Inc., andMerck & Co., which take raw ingredients and turn them into pills and vialsfor pharmacies and hospitals. At least 15 of Hisun’s products were banned fromU.S. import in September. Hisunsaid it’s working to fix problems at the plant, and confirmed the broadoutlines of the report while declining to discuss each specific violation. Thecompany said it retested the samples in question and said they met standards. “Hisunis maintaining further communication with the FDA, and activelypushing forward rectifications,” the company said in an e-mailed statement. Thecompany said the man fled over a misunderstanding caused by a language barrier,and that he took an electronic key used for one of the lab machines, not a datastorage device. Hisunisn’t alone in its violations of FDA rules. During an August inspection ofanother drug ingredient manufacturer, Zhejiang Hisoar Pharmaceutical Co., FDAofficials found that quality records had been deleted and test records beenaltered, with failing results sometimes going unreported, according to recordsobtained through another Freedom of Information Act request by Bloomberg. Pfizer, Novartis Like Hisun, Hisoar makes ingredients for some of theworld’s biggest brand-name drugmakers, including Pfizer and Novartis AG. A 2012stock exchange filing shows that Hisoar has a 20-year agreement to supplyantibiotic products to Pfizer Asia Manufacturing Pte Ltd., a subsidiary of theNew York-based drugmaker. Hisoar declined to comment. China’s drug regulatorybody, China FDA, said it didn’t have an immediate comment on the violations orits relationship with the U.S. agency. The FDA declined to comment beyond theinspection documents on Hisun or Hisoar. Pfizer and Novartis both said they’re aware of theinspection at Hisoar, and were taking action to make sure products were up toquality standards, though didn’t provide specifics. Pfizer said it makes sureproducts meet standards before reaching the market, and that Hisoar’s problemshadn’t affected the quality of Pfizer’s own products. Pfizer also said it wasaware of the inspection at Hisun, and there was no known impact on the qualityof its drugs. Merck can’t discuss supplier relationships, said PamEisele, a spokeswoman. The FDA declined to comment on Hisun’s customers orother details. Data Integrity A fundamental part of the FDA’s inspections in China ischecking what’s known as data integrity. It’s a manufacturing standard --companies make a batch of drug ingredients, test it, record the result, andthen preserve that record. Yet the agency’s handful of inspectors in China havefound numerous, repeated violations -- many of them deleted records of failedtests that could make it seem like manufacturers are better at makingingredients than they actually are. While the FDA publicly says that local regulators arecooperating and want to improve standards, China has also being more assertivein recent years, U.S. government reports show. After the Chinese governmentdelayed visas to let FDA staff into the country, the FDA shut down two of itsthree offices in China. While the visas are now approved, the U.S. agency hasjust one local staff member in Guangzhou, and none at a former office inShanghai, according to a U.S. Government Accountability Office report releasedin January. Even in Beijing, the FDA still has only two permanent druginspectors as of September. ‘Necessary Synergies’ The “FDA is always looking for ways to be moreefficient with its resources and create the necessary synergies among FDA staffat foreign posts, and decided to consolidate its offices in China within theU.S. Embassy in Beijing,” said Jeff Ventura, an FDA spokesman. There are serious risks to patients when drugs aren’tup to standard. In 2008, a blood thinner called heparin was made withcontaminated Chinese ingredients, and 246 deaths in the U.S. were linked to themedicine, according to the FDA. Regulators never found at what point theingredients in the drug, made by Baxter International Inc., were contaminated.At the time, Baxter said it was alarmed that the contamination appeared to havebeen deliberate, though said it didn’t have proof of how it happened. The FDA closed its initial criminal investigation intothe tainted heparin after it became difficult to obtain evidence in China,though it has since re-opened a related inquiry, according to the House Energyand Commerce Committee. The FDA declined to comment on an open investigation. From 2012 to 2014, Hisun received at least 11complaints from customers about their ingredients, including that weren’t up topurity standards, according to the inspection documents. Hisun hadn’t kept anyrecords of the tests that supposedly confirmed that the ingredients were okay,the FDA found during the March inspection. Repeat Violations There were a litany of related violations. “It appearsthat your laboratory practice is to delete failing and/or undesirable resultsand repeat analyses until passing and/or acceptable results are achieved,” theFDA said in the Hisun inspection report. In one example, the FDA found Hisun employees hadturned off software that creates an audit trail while conducting impurity testsin 2014. The initial results were deleted and the FDA said Hisun neverinvestigated why. Instead, the tests were repeated two days later and thoseresults were sent to the FDA. There’s also the issue that Hisun knew about problems-- senior quality management employees told the FDA that the company had beenaware of the “potential for data manipulation” since July 2014, according tothe agency. Hisoar also had data violations. According to the FDA,when they’d test a drug ingredient and find it wasn’t of high enough quality,they sometimes wouldn’t report it, according to inspection documents. In somecases, they’d test it again until it passed, turning failure into success. --With assistance from Jim Jia and Cynthia Koons inNew York and Jasmine Zhao in Washington.
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发表于 2015-11-4 06:29:04
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楼主
）。至于为什么会有这么多的大公司会进口这些被查出问题的中国企业的药呢？？pfizer,novartis,merck??难道他们在供应商审查的时候不能发现么？？这个还是公司和FDA立场的问题，一个是经济机构，all for patients就是一个天马行空的理想，FDA做出这些决策时是不是没有其他偏见或者政治商业原因呢？？
还在社会主义初级阶段