Ellyn McMullin, Axendia
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Next Steps in FDA’s Global Transformation

By Ellyn McMullin
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Ellyn McMullin, Axendia

The agency continues to take measures to ensure the safety and quality of imported medical devices.

Five years ago FDA unveiled its new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain. According to the agency, in 2011 half of all medical devices used in the United States were imported, while 80% of the active pharmaceutical ingredients in medications sold here were manufactured elsewhere. It was optimistically estimated that imports of FDA-regulated products would triple between 2007 and 2015; of course, with the severe recession, the results did not quite reach that projection. However, the increase in imports was still significant.

A key component of the FDA’s new approach (as detailed in a special report “Pathway to Global Product Safety and Quality”) was to partner with its counterparts worldwide to insure and improve global product safety and quality. As reported in 2014 the FDA had at that time more than 60 agreements with their counterparts to share some information in inspection reports.

In a recent FDA Voice blog, Howard Sklamburg, FDA’s Deputy Commissioner for Global Regulatory Operations & Policy provided an update on the progress in developing new agreements. He reported that in 2015, FDA-regulated product shipments into the United States exceeded 34 million. Realistically, he noted, “…we cannot be the inspectors for the world.” The next step is to identify foreign regulators who can be relied on to verify that safety standards are being met and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. Towards this end, three programs have been initiated to meet this challenge.

Medical Device Single Audit Program (MDSAP)

MDSAP is an international approach to auditing and monitoring of the manufacture of medical devices to ensure their safety and efficacy. The two-year pilot that runs thru the end of 2016 includes five countries: Australia, Brazil, Canada, Japan and the United States.

Mutual Recognition Agreements

Two years ago FDA launched the Mutual Reliance Initiative, a strategic collaboration between the FDA and the EU member states. The goal of the program is to determine if the FDA and EU can agree to recognize each other’s drug Good Manufacturing Practice inspections, a potentially time-saving approach. To date the FDA has observed audits in eight countries and will continue to do so for another 18 months before a determination is made.

Food Safety Systems Recognition

The FDA’s Food Safety Systems Recognition program determines whether another country has similar regulatory programs and public health outcomes to what we have in place in the United States. To date, two agreements have been signed (with New Zealand and Canada).

According to Sklamburg, the FDA’s work “will focus on a continued careful reliance on trusted foreign partners; a move away from duplicative work; more risk-based inspections; better data; and the minimization of public health risks globally.” This global focus in the face of economic and technological changes is revolutionary.

We will continue to monitor FDA’s transformation and report as new developments emerge.

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Ellyn McMullin, Axendia

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