FDA Working Toward New National Filer Evaluation Procedure

The Food and Drug Administration is working to update and expand its filer evaluation program, said Domenic Veneziano, director of the FDA's Division of Import Operations, at an event hosted by the American Conference Institute on Jan. 22. The new national filer evaluation procedure, which is still in the works, will also be more collaborative and the FDA is working with importers and brokers to develop the process, he said. The agency does about 1,000 per year now, but under the new system, "everybody that files within" the U.S. will face a review about every four years, he said.

The FDA will also add to industry's involvement within the process by giving filers "a say" as to the FDA's findings and the ability to challenge the agency on any discrepancies, said Veneziano. The current program is somewhat unfair to industry, he said. The FDA plans to get rid of its 10 percent error rate standard, which can be skewed when a single error is used over and over, he said. This will add some flexibility so that a single error that gets carried over isn't counted heavily within the evaluation, he said.

It's more important for the FDA to figure out the importance of an error, he said. "If you provided the wrong product code for the wrong manufacturer, and it circumvented one of our import alerts," that's a far bigger concern than just having a product code wrong that's not subject to an import alert, he said.

The agency will also revise the categories it uses for the companies upon evaluation, he said. The evaluations will be classified by the FDA as either as No Action, Voluntary Action Indicated or Official Action Indicated, which would mean there's serious problems, he said. The FDA highlights some limits to the current program on its website (here), noting "FDA recognizes that the filer evaluation process currently does not distinguish between serious mistakes or omissions and typographical errors, and FDA is working to improve this process." The FDA is also working to update the website for the Department of Import Operations, he said. The update will add a wide range of information related to imports regulated by the FDA, including on processes and contact information.