Perspectives on FDA Globalization Act

In an earlier post I mentioned how Emerson’s Shenling Yang had taken an assignment in Shanghai, China. She’s bringing her expertise in operations management and the Syncade software gained while executing projects as a member of the Life Sciences industry team. Shenling had some thoughts on the FDA Globalization Act of 2009 and its impact on pharmaceutical and biotech manufacturers across the globe.

The Formulary web site sums up the act:

The Globalization Act expands FDA’s authority to inspect foreign plants, to block questionable imports, and to crack down on those who fail to comply. Regulatory “parity” is sought to ensure that lax oversight is not luring manufacturers from the United States to Asia. All registered manufacturers and importers–including generic drugmakers–will have to pay new user fees to support the broader oversight program, and manufacturers will ensure the integrity of product supply chains through electronic pedigrees. FDA also would gain the power to detain, recall, or destroy unsafe, adulterated, or misbranded goods. The act gives the agency added authority to subpoena records and to impose criminal penalties for drug counterfeiting.

The web site continues:

Ironically, legislation that increases FDA inspections of foreign drugmakers may reopen the door to drug importing. A group of leading senators is sponsoring a bill to allow nationwide reimportation of prescription drugs, claiming that the program would save $50 billion over 10 years. All of the imports would have to come from FDA-approved manufacturing plants in Canada, Europe, Australia, New Zealand, and Japan–a policy that assumes more frequent inspections and a viable pedigree system.

Shenling provided her views on the legislation’s impact on Asia:

It will impose higher costs on the Asia Pharma industry, because of its stringent quality compliance requirements, particularly the new requirements to secure entire supply chains. On the other hand, it might also help raise Asia Pharma industry’s competitiveness on the global stage.

The Act may encourage Asia exporters to follow a more structured approach towards securing supply chain and higher quality standards. Hence, it might reduce the cases of non-compliance. Considering the growing export markets, maintaining the quality standards required for these exports might help Asia Pharma companies grow revenues to offset the costs of this legislation.

Shenling described how the ISA95 information model with automation like the DeltaV system and Syncade operations management can help with compliance.

One of the important aspects of the operations management is quality and compliance. By using the latest technology and adhering to the ISA95 standard, Syncade smart operations management suite integrates smart real-time, plant-floor data with your business processes. Through data and workflow management, Syncade suite reduces non-value added activities and variability. By identifying and correcting problems during the manufacturing process instead of post-process, this streamlined workflow improves the product quality and regulatory compliance.

DeltaV Batch uses the ISA88 standard, which helps batch process manufacturers to define a single recipe in a single engineering environment. It reduces time and cost during the documentation, implementation, and validation phases of a project, and enables manufacturers to quickly produce a quality end product.

Thanks for your perspectives on this legislation and its impact on pharmaceutical and biotech manufacturers, Shenling.

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