FDA, NATO Seek a ‘Full, Open Dialogue’
Zeller & Briant discuss the relationship between their two organizations
LAS VEGAS -- If there was one thing the FDA's newly appointed director of the Center for Tobacco Products (CTP) wanted to get across to the members of the crowd at "The FDA's Vantage Point and NATO's Viewpoint" general session, it was that he wants their feedback.
"We understand that we have an obligation to be as clear and transparent with you as possible," Mitch Zeller told the retailers, suppliers and industry representatives in attendance. "When we are told there are things we can be doing better, when we're told there are ways we can be even more clear and transparent, we have to do that. We take that feedback seriously."
"There will always be issues that we'll just have to agree to disagree on," he continued. "But that doesn't mean there can't be a full and open dialogue."
NATO president and executive director Thomas Briant--who joined Zeller on the panel, along with the director of the CTP's Office of Compliance and Enforcement,, Ann Simoneau, and Smoker Friendly's vice president of marketing, Mary Szarmach--echoed Zeller's emphasis on communication.
"If there's one thing I come away with from the FDA, it's that they want to hear from the industry because they're regulating the industry," said Briant. "(NATO) has established a very good working relationship with the FDA: If we want to talk with them, they respond to us; if we want to meet with them, they're there. We have a seat at the table, and that's very important."
That interaction can come in the form of in-person meetings, FDA-hosted webinars, and--perhaps most importantly--NATO's process of collecting retailers' comments on proposed FDA regulations and submitting those comments to the agency.
Zeller shared that such comments are integral to the agency's ability to do its job and that Congress set up the process so that interested parties could participate and share their views.
"Some would describe (the rule-making process) as being a participatory sport, not a spectator sport," he said. "If you have a point of view, it is extremely important for you to participate in this very public process. If you have a point of view and it's not submitted to the official docket that we create, legally, we're not obligated to consider it. If you submit it, legally, we are. We consider all of that when we transition from a proposed rule to considering what--if any--changes should be made to that proposed rule."
"The regulatory process is just that: It's an on-going process," Briant agreed. "We submit our comments, we give our input, and though we may not always agree with the FDA, we know they're listening."