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When are GMPs going to be implemented? That's the question manufacturers are increasingly asking, and the short answer from acting FDA commissioner Andrew von Eschenbach, MD. "They are in process and in progress."
The shorter answer from Iowa Senator Tom Harkin: "Frustrating."
The GMP regulations have been seen as a key part of the landmark 1994 Dietary Supplement Health and Education Act (DSHEA), which liberated the US market for dietary supplements. A year ago, the FDA said they would be issued sometime in 2005. That was before Lester Crawford abruptly resigned as FDA commissioner.
"Dr Crawford last year assured us that the GMPs for dietary supplements would be published in the Federal Register within months," Sen Harkin said at the March 14 congressional hearing for FDA fiscal year 2007 appropriations. "I suppose if you meant a lot of months, yes."
Harkin asked the acting commissioner if he could give assurances that the FDA will work with the Office of Management and Budget (OMB) to get the GMPs published, and whether he could give a definitive date.
"I will continue to commit to you and assure you that FDA will do everything that is needed and required to work with OMB to bring that about as rapidly as possible," said von Eschenbach.
"I do not find the acting commissioner's testimony very encouraging," said industry veteran Loren Israelsen, who helped pen the original DSHEA legislation.
Israelsen cautioned that GMPs are only another step toward industry confidence.
"GMPs are the framework on which to build a robust programme, and that's going to be done company by company," he said. "Remember, there's a rolling three-year phase-in between small, medium and large companies. So we're going to end up with this odd situation of having no idea who's in and who's out of compliance."
"The industry's crying out for this. The public needs it," said Harkin. "It will set up good standards. It will tend to get some of the bad actors out of the way."
Israelsen was less than sanguine even at that assessment, noting that unless the FDA is given adequate funding for enforcement, it could still take years before the GMPs weed out unsavoury manufacturers.
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