According to press reports that first appeared in Bloomberg’s news feed, Gottlieb sent a memo to FDA staff outlining the plan to reorganize how the agency’s 4,000 inspectors go about their work. The reorganization has been several years in the making and was reportedly first conceived to help the agency deal with new responsibilities under the Food Safety Modernization Act. Agency inspectors are expected to be able to handle a variety of assignments, and up to now inspections were apportioned by geographical areas. Inspectors working out of the Dallas district office, for example, would handle whatever inspections came up in their district, be they drug facilities, medical device companies or food firms. The new plan will have inspectors organized through the following six product specific areas:
- pharmaceutical quality
- medical devices
- biologic drugs, which are made from living organisms and include vaccines
- research, including protecting research subjects and assuring data quality
According to Bloomberg, in his staff memo Gottlieb said the reorganization “will make our field programs more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work. We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have.” Bloomberg went on to say that Melinda Plaisier, associate commissioner for regulatory affairs, said in an e-mail that the reorganization will not mean any staff reductions.
Improvement in category-specific knowledge
Some sources in the dietary supplement industry have complained in the past that occasionally inspectors will show up at their plants without seeming to have a firm grasp on the industry. Or they will appear to be applying a set of standards taken from a another product category such as pharmaceuticals to judge dietary supplement GMP compliance. Having inspectors more specialized than in the past could presumably head some of these problems off at the pass.
Having a team comprised of generalists is all well and good, as long as everyone is comfortable working that way. Dan Fabricant, PhD, executive director and CEO of the Natural Products Association, said from his experience as head of the FDA’s Division (now Office) of Dietary Supplement Programs, that’s not always the case.
“It makes a presumption that all of the people who worked at FDA were interested in every commodity regulated by FDA. In my time at FDA I trained 600 different inspectors, and let’s just say that some of them were just not very interested in dietary supplements,”Fabricant told NutraIngredients-USA.
Fabricant said the new organizational model makes sense and could work with inspectors’ own career goals.
“There will still be some cross training, but inspectors will be able to kind of choose a career path. I think it’s better to have an inspector who is intellectually curious about the product category they’re working with. Then you won’t have the situation where they come in and say, this doesn’t look like the drug facilities I’ve been in,”he said.
“The most effective way to oversee the supplement industry is to enforce the current law and aggressively pursue criminals that break it,”Fabricant concluded.