FDA has its work cut out for it to establish a Center for Tobacco Products within 90 days, once President Obama adds his promised signature to the bill giving the agency regulatory authority over tobacco.

The Family Smoking Prevention and Tobacco Control Act gives FDA the responsibility to regulate the production, sale and marketing of tobacco products. The bipartisan legislation passed the House June 12 in the last vote of the week and was sent to the president. The Senate passed the bill overwhelmingly June 11.

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 (See "¹ Galson's Next Career Move: Tobacco Chief?" The IN VIVO Blog, March 13, 2009).

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.

Funding And Duties

User fees based on tobacco firms' market shares will fund the center. Proponents of the bill have promised FDA's funds for other activities will not be diluted as a result of the new responsibilities.

The bill entitles FDA to collect user fees of $85 million in fiscal 2009, building up to $712 million in 2019.

The law will provide FDA with authorities to limit tobacco companies to using black-and-white ads, require firms to remove or decrease harmful ingredients and reduce nicotine levels in their products, ban the use of "light" and "low-tar" in brands and marketing and take measures to reduce youth smoking.

New authorities over tobacco advertising come to an agency that already has shown an increased interest in advertising and promotion since the administration turnover.

Health, Education, Labor and Pensions Committee Chairman Ted Kennedy introduced the Senate bill. "It is precisely because tobacco products are so deadly that we must empower America's premier public health protector - FDA - to combat tobacco use," Kennedy said in a June 11 statement.

The Massachusetts Democrat, who has been absent from Capitol Hill during treatment for brain cancer, said the tobacco industry misleads consumers, makes false health claims, purposefully addicts young people and conceals harmful ingredients in products.

Sen. Chris Dodd, D-Conn., shepherded the bill in Kennedy's absence.

The Administration's Tobacco Veterans

The president applauded the bill's final passage.

"I look forward to signing this bill into law," and to working with Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg on its implementation, Obama said June 11, following the Senate's approval.

Obama co-sponsored an earlier version of the legislation when he was in the Senate during the 110th Congress.

As president, he has named a number of tobacco experts to positions in his administration.

FDA Principal Deputy Commissioner Josh Sharfstein has considerable background with tobacco. Both Hamburg and Sharfstein have expressed support for the agency's regulation of tobacco.

In a June 12 statement, Hamburg said FDA welcomes the authority.

While a staffer on California Democrat Henry Waxman's Oversight and Government Reform Committee in the 1990s, Sharfstein helped draft a version of the bill he will now help implement (² Also see "Sharfstein Takes “Acting” Title Literally, Starting FDA Overhaul" - Pink Sheet, 13 April, 2009., p. 3). He also worked with Zeller on tobacco issues as an intern at the agency in the 1990s.

Obama's pick for assistant secretary for health at HHS, Howard Koh, also has significant background in tobacco issues (³ Also see "HHS Public Health Pick Could Accelerate Tobacco, Sunscreen Oversight" - Pink Sheet, 30 March, 2009., p. 14).

Deputy HHS Secretary William Corr formerly was with the Campaign for Tobacco-Free Kids, but due to ethics guidelines recused himself from tobacco issues.

The legislation was supported by 1,000 groups, including the American Medical Association and the American Lung Association.

"The legislation is an essential step toward improving health and reducing health care costs in the United States," Campaign for Tobacco-Free Kids President Michael Myers said in a release.

Myers noted tobacco use costs the nation $96 billion annually. "Yet, until now, tobacco products have escaped the FDA's common-sense regulations that apply to every other product we consume, from food to drugs to cosmetics," he said.

Bill co-sponsors Sens. Jack Reed, D-R.I., and Frank Lautenberg, D-N.J., tied the effort to health care reform. Passage is a "wonderful way to begin the debate on health care reform, because this could be one of the most significant contributions to prevention of disease in the United States," Reed said at a media briefing following the vote.

Lautenberg noted Congress will need to give FDA appropriate funding. "We're going to have to provide the resources for them to get this job done," he said. "But it's too important. The amount of money that can be saved by improving health for non-smokers, for those who don't smoke, is fantastic. And we're just going to pursue it."

Will Tobacco Be A Drag On FDA?

The bill's opponents will likely be watching to see if their predictions come true.

While most agreed that tobacco use is a national problem, they said FDA is the wrong agency to regulate the tobacco industry.

Some warned that the new authority will cripple FDA. They argued FDA is in dire need of resources and is struggling with its existing responsibilities (⁴ Also see "FDA Tobacco Authority Likely, But Foes Still Press That Agency Will Suffer" - Pink Sheet, 25 May, 2009., p. 8).

Rep. Steve Buyer, R-Ind., also warned members that the bill will lead to legal battles concerning advertising and will likely land in the Supreme Court.

Republican Mike Enzi of Wyoming originally opposed the bill but supported regulation of tobacco elsewhere in HHS. However, prior to the vote on the Senate floor he said he "thought long and hard" and opted to support the bill.

Enzi, ranking member of the HELP committee, authored provisions added to the bill, including requiring graphic warnings on cigarette packages.

Enzi said the bill is the only legislation Congress "will consider seriously" to reduce the number of young people who start smoking.

- Katie Stevenson (k.stevenson@elsevier.com)

Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA

More from Archive

More from Pink Sheet