Chinese-made Pharmaceuticals Pose Risks [View All]

[Celebration]

http://economyincrisis.org/content/chinese-made-pharmaceuticals-pose-risks

Each day, tens of millions of Americans take medication to treat ailments and keep them healthy, but with more and more active pharmaceutical ingredients coming from China, some medicines could be having the opposite effect.

“With little realistic oversight, and more importantly, little ethos of business integrity in China, a major tragedy in the U.S. from a Chinese export is likely in the near future,” Roger Bate of the American Enterprise Institute writes.

..............snip

The lack of oversight poses a major problem for Americans that are required to take medicine. U.S. officials do not have the proper number of inspectors or the time to inspect and test all drugs entering the U.S. market. Oftentimes, they must take the word of suppliers that the drugs have been properly tested.

.................................

“Experts in China tell me that maybe a quarter of ingredients going to western companies come from unknown sources. Unfortunately, western purchasing habits are enabling this type of corner cutting.”

Beware the Risks of Generic Drugs

http://online.wsj.com/article/SB10001424052702303339904576406163574698214.html

Several pharmaceutical industry experts in China privately indicate that up to 25% of ingredients purchased in China by Western companies come from unknown sources. This is very worrying, because if any of these chemicals were substandard, the products made with them could fail to help patients recover from their illnesses, or even could be lethal.

Lower-quality products also mean more recalls, which can lead to dangerous shortages. The number of times when a desired life-saving drug was unavailable in U.S. hospitals and clinics tripled between 2006 and 2010, to a record 211 cases, according to the University of Utah Drug Information Service. In the first quarter of 2011, 89 incidents were reported.

In China, poor oversight, weak regulation and occasional gross negligence are likely to persist in compromising drug quality. The Chinese drug regulator has an overwhelming task in overseeing a rapidly expanding and already vast industry. The Food and Drug Administration has established an office in China and is increasing investigations of the plants that export to the U.S., but it is woefully understaffed. At best, it can assess each site only once every 13 years.

Deal in Place for Inspecting Foreign Drugs

http://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=all

The agreement will not affect the making of over-the-counter medicines or vitamins , whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China.

Nor will the agreement change the F.D.A.’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.

Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the F.D.A. the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees.

The industry changed its stance for several reasons. First, the heparin scandal scared everyone. The fake ingredient was good enough to pass a sophisticated test, so the conspirators probably knew that deaths would result, reflecting a callous level of greed. And the Chinese government refused to allow the F.D.A. to investigate, suggesting that the perpetrators were not only smart but politically well connected.

.............

Generic drug fees will be included in a package of industry fees — including those for branded drugs and medical devices — in legislation the Obama administration is expected to send Congress in January. Such fees were first approved in 1992 and have become a vital source of F.D.A. financing, although some consumer groups say they have led the agency to become too cozy with those it regulates.