FDA Planning Pilot for Document Review Processing, Express Carriers to be First Participants

The Food and Drug Administration (FDA) is planning to begin a new pilot early next year aimed at improving document review, said Michael Mullen, executive director of the Express Association of America (EAA). The pilot, which would allow for more timely FDA review of documents at the border, is expected to begin during the first quarter of 2013, said Mullen in an interview. Mullen, who met with FDA officials Nov. 2, is leading an industry push for an update to FDA customs processes. Mullen said the pilot isn't expected to require formal announcement through the Federal Register.

(An industry group led by the EAA and Mullen submitted to the FDA a long list of recommendations that they believe would facilitate FDA processing of goods across the border. The agency previously said it was reviewing the recommendations. See ITT's Online Archives 12091423 for summary of FDA's previous discussion of the recommendations. Email ITTNews@warren-news.com for copies of the recommendations.)

Under the FDA pilot, the agency will centralize its document review resources to more quickly process document submissions, he said. The program will start with the four express companies, UPS, DHL, FedEx and TNT, which will also provide suggestions for which ports to start in, said Mullen. "Once they get it set up and running and we see how it goes, they are going to want to expand it beyond just the four express companies," he said. That's when the FDA would need to seek comment. The industry group previously found that some two-thirds of the FDA holds were due to requests for documents. The The FDA didn't respond to a request for comment.

The new program will involve making more FDA personnel available for the "prime times for processing express shipments, which is night time," Mullen said. The large volume of shipments carried by the express carriers will also provide some "lessons learned fairly quickly about how effective the process is and where it might be useful to apply it more broadly," said Mullen. Some details aren't decided, but the pilot will likely mean longer hours during which the carriers can respond to FDA document requests, such as a request for a manufacturer's FDA registration, and therefore allow for quicker processing, said Mullen. Typically, the FDA has operated on a "9 to 5" basis, which has meant carriers have no way to submit the requested documents and get their cargo release outside of those hours, said Mullen. This will "give them a pool of people who are working that problem in more real time." Things like inspections and requests for samples won't see a change under the pilot, he said.

Better Trade Facilitation Statistics

The FDA will also begin work to develop more detailed statistics on the number of products detained and denied entry by the agency under the PREDICT system, the FDA's risk-based screening system for imports. The FDA is still working out how exactly to do it, but it will likely be a "monthly type of assessment," Mullen said. "In terms of measuring your efficiency," the overall percentage of shipments held for any reason should go down while the percentage of non-compliant products found goes up, he said. The statistical review will provide more information on the agency's efficiency, said Mullen.

The FDA will also be looking at the time of release on a district by district basis. "We're hopeful that will help them identify district operations that represent best practices," said Mullen. Mullen said the FDA has also agreed to bring a neutral outside party to perform an evaluation on PREDICT, which will also start early 2013. The statistics effort also won't require a formal announcement, he said.

The agency also agreed to meet quarterly with the industry group that submitted the recommendations, something group is "delighted" about, Mullen said. The Nov. 2 meeting was the second on the industry recommendations and was focused on items the FDA believes it can act on in the near term, said Mullen.

ITACS Improvements

Mullen said there is also discussion about how to improve the Import Trade Auxiliary Communication System (ITACS), which has largely been a positive step for communication between the trade community and the FDA. There was talk of "allowing importers submit information back to ITACS" when something is held, though there's some concern with the confidentiality of information, he said.

The FDA did say some of the group's recommendations weren't considered "under their purview," Mullen said. For instance, a request to resolve accuracy problems with the manufacturer identification (MID) code, used by CBP to identify parties shipping goods into the U.S., isn't something the FDA could take on by itself and would need to coordinate with a number of other agencies, he said.