Speaking with us at SupplySide West, Dr Fabricant said: “What happens in DC is very important, to have someone good at HQ, but at the same time it’s important to have those interactions at district levels because they’re the ones who will be in the facilities.”
“GMPs are really still front and center for the FDA,” he added. “The Agency has made it clear that GMPs are their tool for regulating the industry. There’s definitely a will from the Agency to use injunctions and other tools at its disposal when they find GMP violations.
“One thing we’re really looking at is when the whole industry has been inspected and we can start drawing a baseline. When we have those data points then we’ll see what we can make of it.”
NDIs… reissuance of the draft guidance… when, when, when?
The second NDI draft guidance is scheduled to be completed in 2014, according to the CFSAN priorities, said Dr Fabricant, but we are getting into an election cycle then not much comes out in terms of regs and guidance.
“Given that this is a guidance then this may get tiered down further,” he said. “If the Agency put it in their plans, we’ll take them at their word and see what happens.”
GMO & ‘natural’ – definitions?
The states are really pushing on mandatory GM labeling, he said. “I don’t think anyone can work around 50 different label standards so I think that is going to put pressure on the federal government in that way.
“With respect to natural, federally, there is an interest, at least in one of the proposed GM bills, in having FDA define natural for foods and packaged foods.”
Dr Fabricant also discussed a proposal to have NPA come up with a natural seal for foods, following on from its seal for household products and personal care products. “We’re at the point where we’re trying to harvest industry knowledge and then we’ll start reaching out broader and getting other stakeholders involved.”
Without giving the whole interview away, Dr Fabricant also talked about DSHEA, the next industry champions in Congress, the next generation of champions from within the industry, and the potential implications of the recent FTC-Bayer issue.