Device, Drug Manufacturers Push FDA for Greater Consistency, Standards When it Comes to Good Importer Practices

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Michael Causey, Editor & Publisher,

Michael Causey, Editor & Publisher,

It sounds like most folks think the FDA should be doing more to strengthen the quality and consistency of medical devices and drugs that come into this country. And that includes the folks who make the stuff.

FDA recently unveiled a draft guidance for industry, “Good Importer Practices.”  It was issued in response to recommendations contained in the Action Plan for Import Safety: A Roadmap for Continual Improvement (Action Plan) back in November 2007, by the Interagency Working Group on Import Safety (Working Group) established by Executive Order 13439 (see

The Action Plan recommends that the Federal Government work with the importing community and other members of the public to develop Good Importer Practices and issue guidance. The Action Plan specifies that the focus of these practices should be to ensure that imported products meet U.S. standards, as well as to promote effective supply-chain management. The Action Plan recommended that these practices be risk-based and provide concrete guidance to the importing community for evaluating imported products.

That’s all well and good, but there’s a hint of frustration underlying some of the comments from industry.

Quick example, AdvaMed notes, “Device companies have reported that one of the challenges they face in complying with the requirements proposed in the guidance is FDA’s uneven documentation requirements at different ports of entry.” They call on FDA to standardize its documentation requests at such ports.

AdvaMed, and other commenters, also call the FDA out to be more specific in some of its terms. Reminiscent of the way 21 CFR Part 11 was at first interpreted way too broadly and served to stymie the technology it had meant to promote, commenters here want the FDA to be very clear when using terms like “appropriate steps,” without spelling out what those are.

Pfizer wants the FDA to be tougher. It also calls on the agency to establish a voluntary certification program for “highly compliant importers.” Those that agree to a higher bar would also get faster review status from the FDA because they were identified as “trusted importers.” That’s not a bad idea and reminds me a bit of how some folks who are pre-screened at airports get to move through the line faster.

PhRMA calls for clarity, too. They also want to see a concise executive summary and a glossary – just so we all know we’re talking about the same thing here.

They also raise an interesting point: “The draft guidance contains expectations about the risks and compliance history of firms which manufacture, distribute or transport products and also proposes that websites of all relevant regulatory authorities be checked for information on non-compliance…much of the information sought in this provision is simply not publicly available.”

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