By Kevin E. Noonan --
There may be some good news with regard to the safety of generic drugs obtained from China. Despite recent evidence that the U.S. Food and Drug Administration has been woefully deficient in inspecting generic drug manufacturers overseas (see "The Effect of Foreign Generics on the U.S. Drug Supply - Part I") and instances of contaminated excipients obtained from overseas manufacturers appearing in a variety of pharmaceutical products (see "The Effect of Foreign Generics on the U.S. Drug Supply - Part II"), it is possible that the situation is less dire when it comes to prescription drugs.
A story by Jean-Francois Tremblay in the June 18th issue of Chemical and Engineering News (published by the American Chemical Society), reports that the FDA inspects generic active pharmaceutical ingredient (API) makers more regularly than for other products, particularly over-the-counter (OTC) medications (see "Trusting Medicine from China").
The recent scandals include glycerin tainted (or substituted with) diethylene glycol, which has resulted in several deaths in Haiti and Panama and a massive recall of counterfeit toothpaste sold in cut-rate retail outlets in the U.S. Also, a former Chinese government official in charge of drug safety was recently convicted (and executed) for taking bribes resulting in approval and sales of unproven (and unsafe) pharmaceuticals. These events have prompted officials from China's Pharmaceutical Producers Association (CPPA) to decry the implication that drugs produced in China are unsafe. For example, the article quotes Yan Zhou, general secretary of the CPPA as acknowledging the
counterfeiting problem in China, but asserting that this does not represent the country's largest drug exporters. She is quoted as saying she knows of no instance where APIs produced in Chinese factories have not been inspected by the FDA.
Despite this good news, the Synthetic Organic Chemical Manufacturers Association (SOCMA) has continued to call for more FDA inspections. This group may have a point, in view of the fact that the FDA conducted a total of 200 plant inspections in Indian and Chinese drug companies selling or supplying drugs to the U.S. market over the past seven years. In contrast, the agency conducted 1,222 quality-assurance inspections in U.S. drug manufacturing plants in the past year alone. And these inspections may be questionable in some cases, since the kind of inspections conducted abroad are rarely as rigorous as those U.S. firms routinely undergo, and are always arranged in advance (unlike the "surprise" visits American drug companies are subject to; see "The Effect of Foreign Generics on the U.S. Drug Supply - Part I").
The Chinese officials are not accepting complete blame. According to Xiao Dong Li, deputy director of technical operations at Shanghai Pharmaceutical (one of China's largest drug producers), although he would welcome additional FDA inspections, foreign importers "bear big responsibilities" for the recent tainted drug incidents. His basis for the statement is that Chinese companies produce products for the foreign market according to their customer's specifications. If these specifications are unsafe or inappropriate, the responsibility lies outside China, according to Mr. Li. He also maintains that the labeling for prescription drug APIs are "extremely difficult to falsify" and in any event, they are tested again by the FDA "upon receipt." And he discounts the efforts for increased FDA inspections urged by SOCMA, since "[s]ometimes SOCMA or other organizations urge quality control as a trade barrier to protect the interests of their members."
In fact, it appears that the FDA concentrates their efforts on APIs used in prescription drugs, and exempts from inspection plants making components of OTC drugs. Instead, the FDA inspects only those factories that make "pills, syrups or ointments" prepared from ingredients sourced from uninspected suppliers. The FDA uses a variant of the honor system, depending on the manufacturers having "systems" in place for ensuring ingredient integrity, as well as relying on the manufacturers being able to identify substandard reagents (which evidently did not work with regard to glycerin; see "The Effect of Foreign Generics on the U.S. Drug Supply - Part II"). Since 2002, however, the FDA has increased its systematic determination as to which factories it inspects, using a "risk-based" method, and in 2004 instituted a higher degree of regulatory oversight and inspections for factories making prescription pharmaceuticals or APIs. While the agency justifies this approach as "best allocat[ing] its oversight resources," it is less than reassuring for consumers of OTC products that have escaped the more rigorous inspection procedures.
Despite these difficulties, the economic realities dictate that more and more APIs and OTC drugs for the U.S. market will be produced in countries like China and India. These realities make it critical that the FDA establish a more reliable format for protecting American consumers from the inevitable adulteration, intentional or accidental, that can be expected to occur in future.
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