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18,20 heathcare highlights 8/25/08 1:40 PM Page 2

HEALTHCARE
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TOBACCO
REGULATION
UP IN THE AIR
Long identified as a serious health risk,
cigarettes may soon be regulated by the
FDA thanks to a recent decision by the
House of Representatives. The House
voted overwhelmingly to give the
agency the power to regulate tobacco
products in a move endorsed—surpris-
ingly enough—by Phillip Morris.
The new bill would allow the FDA
to decrease the nicotine in cigarettes to
nonaddictive levels (while not com-
pletely eliminating it) and would ban
flavored cigarettes that appeal to young
people, with the exception of menthol,
which has a largely African-American
market. It would also require tobacco
companies to provide detailed disclo-
sure about the ingredients in their
products and replace current health
warnings with more graphic ones such
as pictures of lung disease and tumors.
The regulation would be overseen by
a new office under the FDA, and funded
largely by fees paid by tobacco compa-
nies. Many health organizations such as
the American Lung Association and the
American Heart Association support the
bill; however, other antismoking advo-
cates have said that it doesn’t go far
Addressing the
enough. In addition to not being able to
eliminate nicotine from cigarettes, the
Flood of Generics
FDA would still not have the power to THE WAIT IS LONGER THAN EVER THIS YEAR FOR COMPANIES SEEKING
ban tobacco products altogether. generic drug approval, with an average delay of more than a year and a
While Phillip Morris’s endorsement half, according to the FDA. Requests are pouring in as some of the
has helped lend weight to the bill, other brand-name giants are losing patent protection, opening the door for
tobacco companies have not been as cheaper alternatives to drugs such as Merck’s cholesterol-fighting drug
supportive. The bill must still clear the Zocor and Pfizer’s blood-pressure drug Norvasc.
Senate and the White House before it is Companies seeking drug approval waited an average of 19 months
enacted. —Nicole Lieurance last year, up from 17 months in 2006. And FDA officials say it’s only going
to get worse as more big drug names lose protection.
Gary Buehler, Director of the FDA’s Office of Generic Drugs, told
Reuters that the agency is also working to streamline their approval

 


process. “We still have not been able to catch up with the increase in




submissions,” he said. “We’re very aware that people are waiting for the



products.”
As the agency waits for more government funding, it has asked the
generic industry to start paying fees, as brand-name drug-makes already
do when seeking drug approval. —Nicole Lieurance

20 PM360 SEPTEMBER 2008

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