May 18, 2010    Volume 17, No. 8

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You Don't Know Where Your Drugs Come From And Neither Does The FDA; U.S. Imports 90 Percent Of Its Antibiotics (And Vitamin A) From China


By Richard A. McCormack
richard@manufacturingnews.com

China has surpassed the United States as the world's largest manufacturer of bulk drugs, vitamins and nutritional supplements and is now exporting a large portion of its production to the United States. Tens of millions of American consumers have no idea that the majority of the over-the-counter drugs they are purchasing now originate in China, where there are "relatively few regulations related to pharmaceutical exports in comparison to industrialized economies," according to a report commissioned by the U.S.-China Economic and Security Review Commission. The increasing dependence on China for active pharmaceutical ingredients and nutritional supplements "presents a range of issues for concern."

In 2008, China produced $25.7 billion worth of bulk drugs (up 23 percent from 2007), and exported $17.6 billion of that output (an increase of 30 percent over 2007). "For many years, China has been exporting more than half of its bulk drug products to nearly 200 countries," according to the study by NSD Bio Group. "As a result, China-sourced raw ingredients have a growing impact on the global pharmaceutical market."

The country is now the world's largest producer of acetominophen used in Contac, Benadryl, Excedrin, Sudafed, Theraflu and Vicks, among others. It is the world's major producer of Vitamin C, exporting 90 percent of its annual production of more than 100,000 tons.

The United States needs two tons of heparin per month. Seventy percent of that is sourced from China, says the study. Tainted Chinese heparin (made from pig intestines and used as a blood thinner) supplied to Baxter International caused the death of 81 Americans in early 2008. After a fall-off of heparin exports in 2008, "the situation has changed in 2009," says the study. "Heparin exports for the first quarter of 2009 increased 155 percent compared to the first quarter of 2008. The price of heparin also doubled (to $4,354 per kilogram) in the first quarter of 2009."

China accounted for 61 percent of all ibuprofen sold into the U.S. market in 2008, with its product used in Advil, Aleve and Motrin, among others. More than 90 percent of the tetracycline supplied to the United States and used in most antibiotics is now supplied from China.

In the United States, virtually all companies manufacturing pharmaceuticals are inspected by the Food and Drug Administration. But not imports, which freely enter the country from factories that will never see an American inspector. From 2002 until 2006, "an average of just 15 of the 714 Chinese drug plants that export to the U.S. were actually inspected by FDA," says the study entitled, "Potential Health and Safety Impacts from Pharmaceuticals and Supplements Containing Chinese-Sourced Raw Ingredients." "At this rate, it would take more than 50 years to inspect all of the plants."

But the number of plants that produce drugs exported to the United States is thought too be far higher than 714, according to the study. "The exact number of foreign establishments that have never been inspected is unavailable. Most of the foreign inspections performed are conducted as part of a review associated with processing an application to market a new drug...rather than inspections for monitoring the quality of marketed drugs. Although the FDA has used a risk-based process to develop a prioritized list of foreign establishments for inspections to monitor the quality of marketed drugs, few are completed in a given year."

Any inspection of an overseas factory requires that an inspector arrive announced, unlike in the United States. If an inspector finds a problem, there is no way to enforce a solution, or to follow up to assure that problems have been addressed. "Finally, the linguistic barrier can make foreign inspections more difficult. FDA does not generally provide translators to its inspection teams. Instead, it has been the norm to rely on an English-speaking representative of the foreign establishment being inspected, rather than an independent translator."

The FDA has started an initiative to keep track of drugs entering the United States, but "the implementation of this proposal is not certain and would require coordination with multiple federal agencies," says the report. It will be difficult to keep track of all the various types of "agents" who import drugs into the United States. The FDA says it will rely on foreign government inspections, but most of their inspection reports are not translated into English.

The FDA inspected 1,479 foreign drug manufacturers between 2002 and 2007. "Because the FDA does not know the number of establishments subject to inspection, the percentage of those inspected cannot be calculated with certainty," according to the study. "Aside from internal distractions relating to perceived point of conflict arrangements, collaborations, poor morale, frequent scandals and other impeding factors, it is believed both in and outside the agency that the FDA has reached (or is extremely close to approaching) a breaking point. It has been argued with increasing momentum, that a complete segregation of the responsibilities of the FDA should be seriously evaluated."

Not long after the Chinese heparin scandal, the Pharmaceutical Market Access and Drug Safety Act was introduced in Congress. It wasn't long before the pharmaceutical industry lobbyists objected. "Backlash against proposed legislation has begun with the Pharmaceutical Research Manufacturers of America, among others, publicly opposing the legislation based upon the acknowledged worldwide threat of counterfeit products," says the study. "Notwithstanding this potential significant challenge to U.S. pharmaceutical research and biotechnology companies, many of these same drug manufacturers continue to increase the pace of outsourcing many R&D functions of the drug discovery and development process, as well as FDA required clinical trial obligations, to China in pursuit of reduced costs."

The report is located at the U.S.-China Commission's Web site, http://www.uscc.gov, under the "Research and Reports" link.


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