Supplement GMP Inspections Slowing As FDA Makes 'Potential' Data Useful
This article was originally published in The Rose Sheet
Executive Summary
FDA doesn't expect o continue increasing GMP inspections at the rate established from fiscal 2013 through 2017, says Cara Welch, assistant director of the office in the agency's Office of Dietary Supplement Programs."We're not going to keep growing at that rate because we have a lot of regulations we have to inspect and we're always resource strapped," she said at a recent industry conference.
FDA doesn't have resources to continue inspecting more dietary supplement facilities every year but it has ample data to increase the effectiveness of the inspections.
The Office of Dietary Supplement Programs doesn't anticipate continuing the rate of growth for good manufacturing practices inspections established in fiscal 2013 through 2017, says Cara Welch, senior advisor in the office in FDA's Center for Food Safety and Applied Nutrition.
"We're not going to keep growing at that rate because we have a lot of regulations we have to inspect and we're always resource-strapped. It's important to do what we can with the information and the resources we have," said Welch on May 16 at the Dietary Supplements Regulatory Summit hosted by industry trade groups in Washington.
The number increased steadily from 386 in FY 2013 to 576 in FY 2017, but as of April 30, the midpoint of the federal fiscal year, FDA's supplement GMPs for FY 2018 were 188 (see chart below).
ODSP's information has been gleaned from GMP inspections that FDA's Office of Regulatory Affairs began following the agency's publication of the supplement GMPs final rule in 2007. Since FY 2033, form 483s listing GMP deficiencies have been issued to at least 59% of the inspected facilities, and during FY 2016-2017, 15% to 20% of the 483s included "official action indicated" findings, FDA's most stringent statement on GMP problems.
The OAI rate, Welch said, is three to four times the rate that CFSAN finds in other industries under its oversight. "It really is pretty high and we're not seeing a decrease yet," she said.
There's also a high commonality in GMP problems found across separate facilities. "A lot of the same citations are being observed during inspections," Welch said.
GMP Inspections Upward Trend Slowing
FDA's supplement GMP inspections, above left, increased steadily from FY 2013 to FY 2017 but are slowing in fy18, while The number of "official action indicated" responses, above right, isn't slipping.(* FY18 figures are through April 30.)
FDA Office of Dietary
Supplement Programs, May 16, 2018
The most common regulations under Part 111 – the codification of the supplement GMPs in FDA's list of rules and regulations in CFR 21 – include failure to establish specifications for ingredients and other components used to manufacture products, 111.70, and verifying those specifications are verifying every finished batch of supplements meets product specifications, 111.75.
Welch said inspections "pretty consistently" are finding 111.103 violations, quality control personnel failing to approve or reject all processes, specifications, written procedures, controls, tests and examinations to assure the identity, purity, strength or composition of a product.
She added that problems with 111.153, which details a firm's responsibility for processing product complaints, also are a concern.
"That sort of feedback loop is really important to the [current] GMP system. Once you have a compliant product go out the door, tracking it when it comes back in is really important," Welch said.
A supplement manufacturer or marketer's response on product complaints "feeds pretty clearly into adverse event reporting," not part of the GMP rule but a separate requirement firms must meet, she said.
"If you're not properly reviewing and investigating your product complaints, it sort of gives an idea that you're probably not reviewing and investigation your adverse event very well."
The GMP final rule sets out requirements for establishing quality control procedures, designing and constructing manufacturing plants and testing ingredients and the finished product. Large companies were required to be compliant in 2008, medium-sized businesses in 2009 and small companies in 2010, which is when FDA began inspections and published a small entity compliance guidance.
Industry stakeholders held out hope for an ODSP funding boost in FDA's FY2018 budget, but the agency's $2.9bn appropriation, not including user fees, was up $135m from the previous budget and did not provide additional support for the office. (Also see "Appropriators' Interest Could Point To FDA Supplement Programs Funding Boost" - HBW Insight, 18 Dec, 2017.)
Data Moving From Potential To Use
Information from GMP inspections and from other pieces of FDA's regulatory oversight of the supplement industry, beginning when Congress passed the agency's regulatory framework in 1994, gives ODSP a rich field to mine for indications on more effectively deploying the office's resources. The results aren't in yet, though, Welch said.
"At this point the majority of the information that we have on hand is currently is just potential data. It's information we have and the task we have is to turn it into something we can use," she said.
ODSP and other FDA units that also conduct supplement industry oversight are working to get on top of the data. "What we need to do of course is to leverage this information and improve our program," Welch said.
One area of improvement driven by data analysis will be in ORA's approach to inspecting supplement manufacturers and other facilities subject to the agency's supplement manufacturing, labeling and marketing regulations.
ORA in 2017 implemented "program alignment" to assign staff to inspect facilities in industries under FDA oversight they are more knowledgeable. (Also see "Dietary Supplement Sector Warnings Jump With FDA 'Program Alignment'" - HBW Insight, 26 Dec, 2017.)
"We have food staff that can really dig into the food requirements and ideally give you a more-informed inspection and give us a better picture of the true compliance and what's happening in that facility," Welch said.
Working with improved data analysis, those inspections should bear better results. "We want to get as much information on the front end so we can really have an idea of what is this inspection that we're walking into? What are these operations that we're walking into? Do we have the right personnel to inspect this facility? I think that's really important," Welch said.
"When you're at an organization as large as the FDA, or the federal government for that matter, it ends up being a lot of data and a lot of numbers and that's certainly not how we in the program office see the industry, but it is an import aspect of what we track as we regulate the industry," she added.