The likelihood of Congress handing FDA responsibility for regulating tobacco has ignited debate over whether the new purview would distract an already struggling agency from its mission.

California Democrat Henry Waxman's H.R 1256, the Family Smoking Prevention and Tobacco Control Act, will move next to the House floor for a vote, after its March 4 approval by the Energy and Commerce Committee.

With support from the president, previous passage in the House, and reportedly enough votes to pass in the Senate, observers are handicapping passage as likely.

The bill's advocates say it will be positive for the public health.

During the markup, Waxman, who has introduced variations of this bill for more than 10 years, said FDA has the right science-based expertise to regulate tobacco.

The Energy and Commerce chairman said the bill's funding design, based on generating user fees from tobacco companies, will prevent it from diverting resources from FDA's therapeutic mission.

Regulation of tobacco under a new center in the agency "will empower FDA to prevent tobacco companies from making false and misleading claims about their products," Waxman said. "And it will give FDA the ability to require changes to product content or design to protect the public health."

Waxman said it will prevent "the dangerous and all-too prevalent marketing and sales to kids." He claims the bill could save an estimated $75 billion in related health care costs.

Center For Tobacco Products

Under Waxman the committee considered several health-care related bills that passed the House in the last Congress and have been revived.

His bill was clearly the most controversial and dominated deliberations. It passed the committee on a 39-13 vote, with six "yeas" from Republicans.

The bill would create a Center for Tobacco Products within FDA, with authority over cigarettes and other tobacco products.

Among other major provisions, the bill would give FDA tight control over tobacco advertising and prior approval over any labeling statements, and strictly define adulteration of such products.

The legislation also would require manufacturers and importers to provide information on ingredients, including harmful constituents of smoke.

Firms would have to provide to FDA all documents created after the bill's enactment "that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products [and] their constituents."

"Wrong Agency At The Wrong Time?"

Former FDA chief counsel Peter Barton Hutt is "horrified" of what regulating tobacco will do to FDA.

Hutt, currently with Washington-based Covington & Burling, said he would like to see the authority over tobacco "handed to the Federal Trade Commission, the Centers for Disease Control...or any other agency other than FDA."

"FDA is unable to do the work that it is given responsibility for today," Hutt said in an interview. "Even with user fees, the agency will be further dragged down and unable to do its job with the responsibility for regulating tobacco."

Further, he said regulating tobacco goes against FDA's mission statement. "You are asking an agency that requires proof of safety and effectiveness" to regulate products that "are not safe or effective."

William Hubbard, a former FDA deputy commissioner, acknowledged one concern is that the agency "has gotten new responsibilities without funding in recent years."

But Waxman's bill "does come with a very substantial assured funding base," he noted, adding he is optimistic the new responsibility will not cripple the agency.

Hubbard is an advisor to the advocacy group Alliance for a Stronger FDA, which has not taken a position on Waxman's bill.

During the markup, Energy and Commerce Ranking Member Joe Barton, R-Texas, and other opponents highlighted recent salmonella outbreaks as examples FDA is struggling and cannot afford to take on additional responsibilities.

"The FDA is the wrong agency at the wrong time to give this type of responsibility," Barton said.

Rep. Nathan Deal, R-Ga., noted former FDA Commissioner Andrew von Eschenbach has said if FDA were given authority over tobacco, it would be forced to shift its resources.

Another Republican member, Rep. Mike Rogers, Mich., said he voted for Waxman's bill in 2008, but improving FDA's food safety takes precedence this year. The committee voted down Rogers' amendment to prevent FDA from spending on tobacco regulation until the agency increases its food safety inspections by 10 percent.

Waxman noted the committee will take on food safety issues at another date. The committee has scheduled a hearing on March 11.

User Fees To Fund "Entire Program"

Waxman maintains the tobacco program in his bill pays for itself but opponents at the markup were not sold.

The bill entitles FDA to collect user fees of $85 million in fiscal 2009, building up to $712 million in 2019. The user fees will pay for the entire program, including startup costs, according to a Waxman staffer.

Republicans expressed concern about a clause in the bill that says FDA will use existing funds during the first two quarters after enactment while it collects the initial fees authorized by the bill.

The bill allows FDA to use existing funds from other FDA accounts temporarily, during the first two quarters after enactment, while user fees are being collected, according to the bill.

After two quarters, all funds borrowed from other FDA accounts must be reimbursed from the tobacco program user fees. Then, going forward, all costs will be covered exclusively by user fees.

Advertising And Free Speech

Rep. Steve Buyer, R-Ind., also raised concerns that the advertising provisions of the bill would violate the First Amendment by significantly limiting advertising. The Association of National Advertisers, the American Association of Advertising Agencies and the American Advertising Foundation raised the same issue in a March 4 release.

Waxman maintained the legislation is consistent with the First Amendment. The agency can create regulations to impose restrictions on advertising and promotion of tobacco products if it "determines that such regulation would be appropriate for the public health," according to the bill.

That determination would in turn be based on a public health risk benefit equation, taking into account the likelihood the regulation would prevent or stop people from smoking, the bill says.

An Alternative Plan

In largely party-line votes, the committee rejected Republican members' amendments.

Buyer proposed a 200-page substitute amendment that would establish a Tobacco Harm Reduction Center as a separate Department of Health and Human Services agency, rather than putting the authority under FDA.

In a release, Buyer says his proposal, which he has also made in a separate bill, H.R. 1260, would promote the prevention of youth smoking, provide for public education about the harmful effects of tobacco use and support harm reduction strategies.

Buyer said his proposal would have less of an impact on advertising and would be easier to implement, while Waxman's would prompt "years of litigation" because of its advertising restrictions.

Waxman said he would be willing to discuss additional amendments before the bill moves to a floor vote.

Tobacco Bill "Next Up"

While the re-emergence of efforts to give FDA authority over tobacco was expected, the bill's prominence in the legislative queue is notable.

Last year, Waxman's legislation passed the House but stalled in the Senate. He reintroduced the bill March 2 (¹ 'The Tan Sheet' April 7, 2008, In Brief). As of March 6, the bill has 124 cosponsors.

Rep. John Dingell, D-Mich., the House's longest serving member and a former Energy and Commerce chairman, predicted during the markup the bill again will pass the House. "The Senate is the obstacle," Dingell said during the markup.

But the outlook in the Senate appears promising.

Sen. Ted Kennedy, D-Mass., chairman of the Committee on Health, Education, Labor and Pensions, introduced companion legislation in the previous Congress. He plans to reintroduce a bill "in the next few weeks" similar to what "nearly passed last Congress, which enjoyed 60 cosponsors including President Obama," a staffer said in an e-mail.

The staffer said "there was not a full Senate vote" in the previous Congress because "we ran out of floor time."

Hubbard said he considers it is "highly likely" the bill will be enacted.

The bill is "next up" for a vote by the House, Wendell Primus, senior policy advisor to Speaker Nancy Pelosi noted March 3 at Avalere Health's Diabetes Forum in Washington.

The House will vote on the tobacco regulation bill before it takes on bills addressing issues including stem cell research, the fiscal 2010 budget, energy and health care reform, he noted.

Primus pitched tobacco regulation as a focal part of health care reform, pointing out the importance of wellness and prevention as part of that initiative.

The Obama administration appears to be on board for increasing regulatory oversight of tobacco products, in part because Obama himself was a cosponsor.

Additionally, HHS deputy secretary nominee William Corr has been an outspoken advocate for tougher government controls on tobacco. He was the executive director of the Campaign for Tobacco-Free Kids, a non-profit national advocacy organization focused on reducing tobacco use among children and adults.

The emergence of Margaret Hamburg, a public health policy veteran, as the expected nominee for FDA commissioner also increases the likelihood for moving tobacco under the agency's purview (see story " ² Also see "Nominations To Lead FDA Coming Soon For Hamburg And Sharfstein" - Pink Sheet, 9 March, 2009. ").

- Katie Stevenson (k.stevenson@elsevier.com) and Michael McCaughan (m.mccaughan@elsevier.com)

Tobacco Oversight Looks More Likely, But Is It Bad For FDA’s Health?

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