The 90-day deadline for FDA to establish a Center for Tobacco Products is running with President Obama signing legislation giving the agency authority to regulate tobacco products.
At a ceremony in the Rose Garden, Obama said the Family Smoking Prevention and Tobacco Control Act is “a step that will save lives and dollars.” Noting the bipartisan cooperation behind the bill’s passage, the president said the law is “a victory for health care reform, as it will reduce some of the billions we spend on tobacco-related health care costs in this country.”
Following the signing, FDA updated its Web site to include a page for tobacco, including a link to smoking cessation products, both Rx and OTC.
“FDA looks forward to taking on this challenge and in doing so will partner with public health leaders at our sister agencies, at the state level, and in localities all around the country. FDA will perform its duties by using the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products,” FDA Commissioner Peggy Hamburg says on the Web page. “FDA will seek input from the public as we begin working to implement the act.”
The act gives FDA the responsibility to regulate the production, sale and marketing of tobacco products. User fees based on tobacco firms' market shares will fund the center, with FDA entitled to collect $85 million in fiscal 2009, building up to $712 million in 2019. Proponents of the law promised FDA's funds for other activities will not be diluted as a result of the new responsibilities.
The legislation poses a number of organizational challenges for FDA to create a tobacco center from scratch by late September. The agency is expected to eventually staff up to approximately 1,000 positions in the new center.
Topping the agency's to-do list will be hiring a center director.
One name that has been floated for the position is Deputy Surgeon General Steven Galson, former director of the agency's Center for Drug Evaluation and Research. The IN VIVO blog reported here on this possibility for Galson.
Another logical candidate is Mitch Zeller, who served as associate commissioner at the agency and headed its Office of Tobacco Programs in the late 1990s before a Supreme Court decision shut that office down.
Zeller, currently VP of policy and strategic communication with Pinney Associates and a long-time supporter of tobacco regulation under FDA, would not comment whether he has been approached about the job.
However, he said the center will likely be on a scale comparable to existing centers. The user fee-based funding in the bill is "certainly of that magnitude," Zeller said.
Zeller noted while "they are not going to hire hundreds of people within 90 days," the agency "could open a door, figuratively, in 90 days. I assume there will be a small group of people to work on this that will have responsibilities to make sure that the deadlines are being met."
"Over time it will grow to a fairly sizable operation," he suggested. The budget "compares with the budget of any other center," he said. "I don't know if they will need to hire the same amount of people, but ultimately we're talking about hiring hundreds and hundreds of people."
The effort is bound to have a spillover effect on FDA's other centers in terms of top-level attention from leadership. The agency is already working to address clear directives from Congress to upgrade its food safety programs, leaving its medical products centers as potentially lower priority areas for commissioner-level attention and resources.
One possible outcome is that the need for a new tobacco center will prompt the agency to revisit its existing structure. Counting the National Center for Toxicological Research, tobacco brings the total of FDA centers to seven.
"The Tan Sheet" reported on the bill moving through Congress here and on the president appointing health care advisors recognized for their smoking prevention activities here. "The Rose Sheet" reported here on the arguments opponents made against the legislation.
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-- Katie Stevenson (k.stevenson@elsevier.com)
