Limited Resources, Expanding Imports Challenge Regulators - Pharmaceutical Technology

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Limited Resources, Expanding Imports Challenge Regulators
The rise in overseas manufacturing undermines FDA oversight of drug quality.


Pharmaceutical Technology


One idea gaining support is for FDA to establish permanent overseas inspection offices in major drug-exporting countries such as India and China. In December 2007, FDA signed a memorandum of agreement with China that encourages the safety certification of exported drugs. The memo also calls for regulators to share information related to inspections and the quality of drugs, excipients, and medical devices. The agreement initially will require manufacturers to register and certify only certain designated drugs that have raised specific concerns about safety or counterfeiting. These drugs include human insulin, paclitaxel, sildenafil, human growth hormone, atorvastatin, oseltamivir, and blood-screening diagnostics. Chinese and US regulators will work to establish a system for cooperative plant inspections and an export-product tracking system, according to FDA Deputy Commissioner Murray Lumpkin.

It remains to be seen whether FDA will gain the resources it needs to support more foreign inspections and clamp down on hazardous drug imports. Despite safety concerns, some policymakers still press for more liberal drug reimportation as a way for consumers to access less costly medicines. Brand-name manufacturers are leery that flexible import policies could open US borders to more counterfeit drugs and unregulated products unless the necessary safeguards are put in place. The makers of generic drugs, however, have raised concerns that high import fees could block the importation of high-quality APIs, as well as generic drugs that meet standards. An appropriate regulatory approach may be difficult to establish.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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