This article is reprinted from "The Gray Sheet" – March 31, 2008
Results from manufacturing facility inspections conducted in one country will easily be shared with regulators in another in the near term, says Larry Kessler, FDA officer and chair of the Global Harmonization Task Force.
"We are now setting up electronic systems to share regulatory auditing information around the world," Kessler, also the director of FDA's Office of Science and Engineering Laboratories within CDRH, said March 27 at a meeting of device industry stakeholders at Harvard University.
The new systems are being developed as part of the GHTF National Competent Authority Report exchange program, he said at the annual Medical Device Regulatory, Reimbursement and Compliance Congress.
The exchange program, in which countries such as China have pledged to participate, is already up and running for sharing among national authorities adverse event reports and information on device returns, modifications and destruction (1"The Gray Sheet" Aug. 22, 2005, p. 19).
Now GHTF participants are moving to include audit reports in the exchange. "So the bad inspection happening in China from the Danish investigator - I'm going to find out about it. And if you think we are going to ho-hum that, you are wrong," Kessler said. "We don't see any advantage in having a product be problematic in one jurisdiction and waiting to see what happens in ours."
FDA Pushes Industry On Harmonization
FDA has increasingly pushed for industry's cooperation in harmonizing regulatory activities, particularly on the inspection front.
First with the accredited persons inspection program and more recently with the "pilot multipurpose audit program" (PMAP), FDA has put forward initiatives sanctioning third parties to audit facilities to fulfill both FDA and other international regulations simultaneously (2"The Gray Sheet" Oct. 23, 2006, p. 14). The programs have been billed primarily as time and resource savers for both industry and FDA.
But manufacturers worry that breaking these barriers will smooth over what they say are valid differences in countries' inspection approaches. Industry fears that observations made by a single auditor will have a global rather than national impact on a firm's ability to market a product.
"That's a legitimate fear," Kessler said. But that potential negative outcome to companies from harmonization is an appropriate balance to the clear positive impact: getting products on the global market sooner via harmonized international premarket review.
Some Asian nations are contemplating a system that says, "if it's legitimately on the U.S. market or the European market, it can go on our market without having to do a re-review," Kessler explained.
"But if you want to go on the market everywhere, you have to be able to accept the consequences that if something goes wrong somewhere, you're responsible everywhere," he said.
Particularly with the development of the electronic exchange of audit information, "you cannot avoid this," Kessler said. "If you don't attack it proactively and set it up to work to your advantage ... I think you are going to lose out in the long run."
There are signs that companies are beginning to respond to FDA's appeals.
Companies have been slow to volunteer for accredited persons or PMAP inspections. But CDRH Director Dan Schultz, who spoke March 27, in Washington, D.C., at the Food and Drug Law Institute's annual meeting, said there recently has been progress in PMAP, which allows a single inspection to satisfy U.S. and Canadian regulations.
The device center chief says that about 10 PMAP inspections have already been scheduled for 2008. At this time last year, only one company of hundreds that had received request letters had volunteered (3"The Gray Sheet" April 9, 2007, p. 18).
"We've been pushing this very hard, and thanks to a lot of perseverance, I can actually report to you that we are finally starting to see some success," Schultz said.
- Jessica Bylander and Chloe Taft
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