FDA's Welch says it's time to find way to acknowledge industry's GMP successes
At a session Friday in Las Vegas at the American Herbal Product Association’s Botanical Congress, Welch, who directs FDA’s Division of Dietary Supplements, said GMP compliance in the industry is still not up to an acceptable level overall, but it is time to pull back if only a little bit on the “all stick, no carrot” approach that has prevailed up to now. Welch said that as the division plans its immediate future it is seeking a way to put out a more granular assessment of industry performance than what the raw numbers yielded by GMP inspections can provide.
Compliant product segments
“On GMP compliance we want to identify the good players. Are there some product types that are largely compliant? We want to start identifying those over the next five years,” Welch said. Among those good players are the largest companies, which she said have now achieved a level where all of the most recent inspections in this group yielded 0% Official Action Indicated (OAI, the most serious finding) determinations. For other groups of companies, Welch said recent figures show that the industry appears to be treading water. The numbers of OAIs, VAIs (Voluntary Action Indicated) and NAIs (No Action Indicated) continued to hover at somewhere around a third each plus or minus a few percentage points.
“The percentage of noncompliance as measured by OAIs is still about 25 to 30%. I say this year in and year out because it is not changing, or you could say it’s not changing fast enough,” she said.
Welch said combing through the GMP statistics shows that the same failures continue to show up year after year. Companies that are not testing incoming ingredients in a compliant manner, companies that have not set adequate product specifications, or those that cannot verify that they have control over what they are making via adequate master manufacturing records or batch production production records continue to provide the dark brushstrokes in the chiaroscuro of the compliance canvas.
Almost good enough is still not good enough
But Welch acknowledged that failures both big and small show up as one number in the data set, and being almost good enough in a certain realm is still not good enough and is still recorded as a failure overall.
“We are seeing some progress, but it is not documented yet in the violation citations,” Welch said. “For example, we are still seeing firms that don’t have a MMR for every formulation. Some of the citations could very well be a case in which they might have most of the MMRs but not all that are required. That is still a violation.”
Welch said as the agency starts to develop a strategic plan for division, one thing that industry should not hold out hope for is that additional resources will be devoted to the regulation of dietary supplements. The division has held steady at 26 full time employees and she doesn’t see that changing any time soon.
Another aspect of the immediate future that Welch touched upon concerns the New Dietary Ingredients guidance. This was first put out in draft form in 2010, and was greeted with consternation by the industry. After calls for its withdrawal and after a series of high level meetings between industry stakeholders and FDA, the agency agreed to take a second look at the guidance’s key provisions and there the matter has rested. Welch said she hopes a revised guidance can be released “soon” and said that when it is reissued, the comment period will be reopened.
But what is clear regarding new ingredients is that many are on the market today that have not gone through the NDI notification process which probably should have, Welch said. She said that to date the agency has received 871 notifications, which works out to something less than 50 annually, about 25% of which have received an “acknowledgement” from the agency, which is a determination by FDA that the agency has no quarrels with the company’s assertion that the new ingredient is “reasonably expected to be safe.”
"I don’t have statistics how many new ingredients are going to market each year, but my gut instinct is that it is more that 30 or 40. We want to see more notifications and we want to see more acknowledgements,” Welch said.