The top official at FDA this week touted a new organizational structure within the Office of Regulatory Affairs (ORA) as part of a wider program alignment initiative, reflecting the fruits of efforts that commenced nearly four years ago to update FDA’s programs in the field.
The revamped alignment moves the agency away from its “historical geographically-focused structure to one that is program-based," and inspection and compliance personnel within ORA will concentrate in one of a number of areas, according to a note circulated to agency employees by Scott Gottlieb, M.D., who was sworn in last week as FDA’s 23rd commissioner.
“The FDA’s program alignment is a broad agency initiative that will modernize and strengthen the agency’s workforce through specialization and improve its public health response with more timely decision making," the agency explained in an emailed statement. “It will also increase the FDA’s ability to rapidly address scientific innovation, the global expansion of FDA-regulated products, and recent changes to the agency’s legal authorities."
Gottlieb said ORA will continue to maintain 20 district offices, but they will no longer be organized within larger regions.
“Instead, the entire reporting chain for ORA’s inspection and compliance staff—from the employees on the front lines to the assistant commissioners at headquarters—will specialize in one of a number of areas," he explained in his memo.
ORA has about 4,800 personnel, including approximately 1,600 investigators.
Under the new organizational structure, ORA has established program directors to oversee six specialized offices in biological products, bioresearch monitoring, human and animal food, medical device and radiological health, pharmaceutical quality and tobacco.
ORA also will organize its import operations into five virtual divisions, Gottlieb advised his colleagues, enabling the agency to better target threats with specialized expertise, while ORA’s 13 laboratories will focus more on specific challenges and be aligned into one of two areas: human and animal food labs; or medical products, tobacco and specialty labs.
“The changes ORA is making will result in the opportunity for an even higher level of technical expertise and more uniform application of ORA’s policies and processes," Gottlieb wrote to agency employees in the note, which was first reported by Bloomberg. “These efforts will also help achieve some of my goals for the FDA, namely to provide more consistency and regulatory certainty as we achieve our public health mission and to make sure we are getting the most consumer protection for the resources we deploy."
Some executives in the dietary supplement industry supported the realignment, saying it could result in more consistent inspections. Michael McGuffin, president of the American Herbal Products Association (AHPA), said his organization has been looking forward to the reorganization into specialized programs.
“AHPA believes that this restructuring will bring more consistency to dietary supplement cGMP (current Good Manufacturing Practice) inspections as compared to the situation over the last few years with some inspectors imposing pharmaceutical cGMP concepts on dietary supplement facilities," he said in a statement. “We hope the changes help improve consistency between inspectors and regions and increase understanding of the limits of the reach of the cGMP regulatory regime."
Commenting on the reorganization in an FDA video, Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition (CFSAN), said, “We really appreciate the move toward having field investigators and laboratory staff who will specialize in food safety."
Despite the realignment, Robert (Bob) Fish, a former FDA official for 33 years, cautioned the specialization concept is hardly a new one at the agency.
Early in his career, he became what was then known as a drug specialist. “We had specialist investigators for a long time in the agency, and as a drug specialist, I did virtually nothing except drug inspections," Fish explained in a phone interview.
Others specialized in areas such as medical devices and foods, noted Fish, an independent advisor of quality and compliance with EAS Consulting Group LLC in Alexandria, Virginia. When Fish joined FDA’s headquarters to serve as director of the Division of Field Investigations, the agency had a roster of national experts who were available to the entire country to help with an inspection.
“It isn’t entirely true that FDA investigators have always done anything and everything that came down the pike," he concluded.
FDA’s realignment, nonetheless, reflects a sea-change from the agency’s perspective.
"Prior to May 15, ORA was already specialized but many inspection and compliance staff were not exclusively specialized in one program area and had secondary specialties in other program areas," the agency explained in an email to INSIDER. "As of Monday, May 15, under the new organizational structure, for any given product type, the entire reporting chain for ORA’s inspection and compliance staff are now specialized in that particular product area."
Previously, inspection staff may have reported to supervisors who specialized in a different area than their subordinate, the agency explained, adding staff will now report to a supervisor with the same expertise.
"Increasingly complex inspections and new regulations and legislation require individuals conducting and reviewing inspections to have specialized knowledge in the program areas," FDA noted. "All specialized staff in a given program will be trained similarly so that industries across the globe experience uniform application of our regulatory standards. We anticipate that deepening our knowledge by specialty area will strengthen ORA’s ability to regulate an increasingly complex and global economy."
In the government’s fiscal year 2016, Larisa Pavlick of the Salt Lake City, Utah-based United Natural Products Alliance (UNPA) was still an investigator for FDA in the Denver District. That’s when she and her colleagues were “sorted," or assigned, to certain commodity groups like food. Pavlick said most of the investigators remained in the areas in which they were working, but not everyone.
At the time of the announcement, FDA employees were anxious because they didn’t know where they were going to be placed, she said in a phone interview.
“The supervisors and above sorted the investigators and placed them where they felt it was appropriate," she said, adding later, “Background and experience was not a consideration when they sorted you into buckets because they will just train you and then you will be qualified."
Pavlick said one person quit because she got sorted in a group she didn’t want to be in, while another investigator who remains in the Denver District was placed where she hadn’t been working.
Asked about the process for determining who works in each specialized office and whether investigators have a say, FDA explained in an emailed statement, "ORA conducted a workforce survey in October 2014, as a means to learn more about the degree of program specialization of ORA investigators, compliance officers and operational managers, and their individual preferences for working in a commodity program."
FDA said it analyzed the data from the survey and compared it against ORA's operational needs.
"In October 2015, staff received their tentative program assignments for the new organizational management structure," the agency divulged. "ORA worked to align our investigators, compliance officers and operational managers into programs for which they were trained, had experience, and to the extent possible, matched their preference."
ORA then reassessed and finalized assignments, conveying them to staff in April 2017, the agency noted.
Pavlick, UNPA’s vice president of Global Regulatory & Compliance, reckoned FDA’s realignment will eventually be positive for the dietary supplement industry.
“You won’t have device people going out and doing supplement work as side work," she explained, “and you’re not going to get people pulled out of … clinical trials to go do a supplement inspection."
She cautioned FDA still faces the challenge of high turnover among investigators and explained it takes an investigator 18 months to go through training and get into the field.
“It really doesn’t matter if you have somebody [who] is supposed to be specializing in a food commodity if you can only keep them for one or two years," she noted.
Still, Pavlick expressed optimism that FDA can fill gaps in knowledge in many districts across the nation if the agency can reduce high turnover and improve training of investigators.
“I think eventually it would be fantastic because then you’d have … the same investigators doing similar work," she said. “They would learn the industry. They would learn the risks. They would learn the products."
Currently, perceived disparities from one inspection—or investigator—to another may be attributable to an investigator’s inexperience or obligations to inspect multiple commodities.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), whose members include large dietary supplement manufacturers, said there have been many discrepancies in inspections from district to district and from one investigator to another.
“You have people coming through your facilities [who] yesterday were in a cosmetic’s plant and tomorrow they are going to be in a drug facility," noted Mister. He indicated some investigators may not be very familiar with 21 CFR 111, the GMPs governing dietary supplements. The investigators perhaps become confused from day to day given their responsibilities to inspect various commodities subject to different FDA requirements, he reasoned.
“The idea of having specialists within FDA who are routinely in supplement plants and are … applying the 111-measuring stick day after day makes a lot more sense to us for continuity and consistency," Mister said in a phone interview.
Commenting in an email on the FDA realignment, Brian Kennedy, a spokesman with the Grocery Manufacturers Association (GMA), said GMA’s “members are supportive of this." GMA represents makers of the world’s food, beverage and consumer products, and its members include such heavyweights as General Mills Inc. and PepsiCo Inc.
Whether FDA’s devotion to specialty offices will bear fruit remains to be seen. Shelly Maifarth, a former FDA compliance officer in the Denver District who began her career with the agency as an investigator and microbiologist, said there is a need for both specialists and generalists.
“Think about doctors," said Maifarth, a principal with the FDA Compliance Group LLC, a regulatory consulting firm in Broomfield, Colorado. “If you’ve got something wrong with your leg, and all the doctors [who] are around are just heart people, that’s not going to help you very much."
How FDA will balance the need for both specialists and generalists is unclear.
“There’s always been generalists who did a little bit of everything," Fish of EAS Consulting Group said, citing, for example, investigators who are located in FDA resident posts, “but I don’t know if this [realignment] means they’re going to have more specialists … than they’ve had in the past."
Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA) who formerly oversaw FDA’s Division of Dietary Supplement Programs, cautioned it’s better to have agency employees who have general knowledge in various subjects and can specialize in an area as well. Absent that, he indicated it was preferable to have investigators who take an intellectual interest in a commodity.
Fabricant indicated the FDA reorganization could provide more room for investigators focused on a specific commodity like food to conduct timely re-inspections of firms severely out of compliance with FDA regulations.
“If we’re specializing, then there’s no excuse not to do re-inspections every six months" of facilities that have been classified official action indicated (OIA), said Fabricant, who referenced an FDA designation associated with recommended regulatory action to address noncompliance with agency regulations.
As INSIDER previously reported, of the 63 dietary supplement companies re-inspected in FY15 for compliance with cGMPs, 32 previously had been the subject of an OAI.
“If you’re the inspector [who] is responsible for dietary supplement facilities in your area, I think you have more skin in the game," Mister observed. “So you want to get back there and clean up the problems more. I think you’re more knowledgeable, so you’re a little bit more confident when you say, ‘OK, … these are the violations. These are the things that absolutely have to change, or we’re going to shut you down.’ I think that gives the inspectors a little bit more confidence and expertise because that’s their specialty."
Such specialized expertise and efficiency, Mister predicted, will translate to better—and safer—products reaching American consumers. That’s certainly FDA’s objective.
“The program alignment initiative," Gottlieb wrote to his colleagues, “is an example of how we can modernize and strengthen our workforce while improving our ability to protect American consumers and strengthen public health."