New FDA Tobacco Leadership May be Catalyst for Action

ROCKVILLE, Md. -- Sometimes change can be a good thing. Will that be the case with the incoming director at the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP)?

As CSNews Online reported on Friday, Dr. Lawrence Deyton is stepping down at CTP to become a clinical professor of medicine and health policy at the George Washington University School of Medicine and Health Sciences. The FDA has tapped Mitch Zeller, a former FDA official who currently serves as an executive with a Maryland-based pharmaceutical consulting firm, to replace Deyton effective March 4.

NACS, the Association for Convenience & Fuel Retailing, is one organization that is looking forward to working with Zeller to achieve their mutual goal of preventing minors from obtaining tobacco products, according to Jeff Lenard, NACS’ vice president, industry advocacy.

The association is not alone in welcoming Zeller to his new role. The change in leadership could be "a catalyst for action," according to Bonnie Herzog, managing director of tobacco, beverage and consumer research at Wells Fargo Securities.

After speaking to several tobacco policy contacts, Herzog noted that Zeller's appointment is not as negative as some people might fear. And though there may be a temporary slowdown on major issues as Zeller gets up to speed, she believes there will be even greater visibility and a sense of urgency on the CTP which could result in actions being taken.

"We feel this could be a silver lining of Zeller's appointment. We feel any action -- whether positive or not for the industry -- will be beneficial as the relative inaction on items such as substantial equivalence approvals and menthol, and this uncertainty has been an overhang," Herzog said.

Wells Fargo Securities highlighted several factors to consider with the change:

• The relationships the tobacco industry has forged with the FDA will remain intact and will continue to progress.
   
• The role of the CTP director is to set the tone with regards to influencing policy, developing new regulation and setting priorities, but creating tobacco policy is a group effort.
   
• Criticism from both industry observers and the public health community has escalated recently on the effectiveness of the CTP.

Zeller brings with him 19 years of experience on tobacco issues. In fact he led the first -- although unsuccessful -- effort to bring tobacco regulation under the purview of the FDA during the 1990s while the Master Settlement Agreement (MSA) negotiations were taking place. The American Legacy Foundation, which develops programs that address the health effects of tobacco use, resulted from the MSA, and Zeller acted as its executive vice president for several years.

"We believe Zeller knows the industry, and the industry knows him which is mutually beneficial," Herzog said. "Furthermore, it appears that Zeller is motivated and has the fire in his belly to get things done which ultimately should relieve some of the overhang on the industry."