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FDA Chief: Tobacco
Rules Could Backfire
By ANDREW BRIDGES
The Associated Press
Tuesday, March 6, 2007; 10:08 PM
WASHINGTON -- Government regulation of
tobacco could backfire by leading smokers to light up more often and
inhale more deeply, the Food and Drug Administration chief said
Tuesday.
In an interview with The Associated
Press, Dr. Andrew von Eschenbach said that if the FDA reduced nicotine
levels in cigarettes, people would change their smoking habits to
maintain current levels of the addictive drug. Bipartisan legislation
introduced last month would give the FDA broad regulatory authority
over tobacco and its ingredients, including nicotine.
"We could find ourselves in the
conundrum of having made a decision about nicotine only to have made
the public health radically worse. And that is not the position FDA is
in; we approve products that enhance health, not destroy it,"
said von Eschenbach, a urologic surgeon and oncologist who was
confirmed as FDA commissioner in December.
A nicotine expert said von Eschenbach's
fears may be unfounded. Dr. Neal Benowitz of the University of
California, San Francisco, said a small study sponsored by the
National Cancer Institute _ which von Eschenbach once led _ suggested
gradually reducing nicotine levels doesn't force smokers to compensate
by smoking more or inhaling more deeply. In fact, Benowitz said, a
gradual reduction can wean smokers from the habit.
And a backer of the legislation said
von Eschenbach misunderstood its thrust: "The bill gives the FDA
the authority to adjust nicotine levels _ if doing so is demonstrated
to save lives," said Matthew Myers, president of the Campaign for
Tobacco-Free Kids. "The status quo is the tobacco industry
decides how much nicotine and other toxic substances are in tobacco
products."
In 1996, the FDA moved to regulate
tobacco. The Supreme Court ruled in 2000 that Congress had not
authorized the agency to do so. Von Eschenbach said repeatedly that
the issue of regulating tobacco is a complex one.
"What I don't want to see happen
is that we are in a position where we are determining that a cigarette
is safe," he said, while acknowledging smoking kills more than
400,000 Americans a year. He later suggested regulation wasn't the
solution.
"We have the opportunity to take a
very important comprehensive, public health approach to this problem.
And it's not a matter of giving FDA regulation or authority. It's a
matter of addressing the public health problem that's before us,"
von Eschenbach said.
The newly introduced bill would let the
FDA act to discourage children from starting smoking and to encourage
adults to quit, in part by reining in advertising, bolstering existing
sales restrictions and strengthening warning labels. It also would let
the FDA order the elimination or reduction of harmful and addictive
ingredients in tobacco. The agency couldn't ban nicotine outright, but
the bill would give the FDA the power to reduce nicotine levels.
"The Bush administration has
consistently undercut public health efforts to effectively regulate
tobacco products and reduce youth smoking. In that context, this
latest statement by an administration official is no surprise,"
said Sen. Edward Kennedy, D-Mass., a co-author of the Family Smoking
Prevention and Tobacco Control Act.
In an hourlong interview with AP
reporters and editors, von Eschenbach repeatedly said the FDA doesn't
need more regulatory authority. When asked if the FDA needed more
money, he suggested the agency needs to look at "enhancing our
efficiencies, maximizing our outputs for the dollar invested on part
of the American people."
Von Eschenbach used a racing metaphor
to describe his vision of the FDA's role as a regulatory agency: Its
guidelines, regulations and policy are like guardrails that rigidly
hem in a speedway that the agency has worked to clear of speedbumps,
he said.
_On food safety, von Eschenbach said
the FDA was working to improve systems that can prevent outbreaks,
enhance its ability to detect problems, trace them to their source and
pre-empt the further distribution of contaminated products. A recent
AP analysis found FDA food inspections fell off by nearly half between
2003 and 2006.
"I don't think you can inspect the
problem away. I believe inspections are an important component of
verification that processes that you put in place to prevent and
eliminate the problem are working," von Eschenbach told AP.
_On food from cloned animals, the FDA
chief said it's the agency's duty to tell consumers whether it's safe,
but not necessarily to allay fears. The dairy industry worries cloning
fears will turn people away from milk.
"Once we have defined that, how
that gets implemented into our societal context, in terms of products
and trade and those sorts of things, those are issues I think that go
beyond FDA," he said.
_On drug safety, von Eschenbach
rejected a wholesale refocusing of the agency's attention to the
safety of drugs once they are on the market. Instead, he said, the FDA
should emphasize safety throughout what he called the life cycle of a
drug, from pre-approval throughout its time on the market.
"I don't think it is something we
should view as simply FDA's shifting its priorities from one place to
another place. I see it as a seamless continuum on a broad
front," he said.
___
On the Net:
Food and Drug Administration: http://www.fda.gov
This original
article
can be found online at:
http://www.washingtonpost.com/wp-dyn/content/article/2007/03/06/AR2007030600583_pf.html
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