Source: Reuter

FDA loosens rules for TV drug advertisements
By Vicki Allen
WASHINGTON (Reuter) Federal regulators said Friday they
would let pharmaceutical companies tout benefits of their
prescription drugs on television, as long as they also cited
major risks and told consumers how to get more information on
side effects.
In a move to eliminate vague ads that repeat the name of the
drug without saying what it does, the Food and Drug
Administration gave advertisers the goahead to be more specific
about their drug's benefits if they also cite its major risks.
Broadcast ads also must tell consumers how to get more
information through a tollfree telephone number, the Internet
or other means.
``By describing realistic standards for television
advertising of prescription drugs, we hope to end the
uncertainty which has plagued both consumers and industry about
the use of this medium,'' Michael Friedman, FDA lead deputy
commissioner, said in a statement.
Because of TV's time constraints, advertisers have been
hobbled by an FDA requirement for a ``brief summary'' of all
important information including side effects, interaction with
other drugs, and effectiveness.
To be exempt from the ``brief summary'' requirement, most
broadcast prescription drug ads just mention the drug's name
without making any claims for what it does or even what it is
intended to treat.
``The institutional ads where they were not talking about
the actual product had a lot of consumers scratching their heads
and wondering what it was about,'' said Don McLearn, an FDA
spokesman.
``This is an acknowledgement that with 800 numbers and the
Internet, consumers can get information other ways. As long as
the ad is balanced,'' McLearn said.
The FDA guideline takes effect immediately, with a 60day
comment period. The policy will be evaluated in two years,
McLearn said. ``There are ad campaigns ready to go right now,''
he said.

``Television advertisements will be more direct and user
friendly. We will be able to name both the product and the
conditions it's intended to treat,'' said Jeff Trewhitt,
spokesman for the Pharmaceutical Researchers and Manufacturers
of America.
``Sure it's going to benefit companies, but we think it's
going to be more of a benefit to consumers. This is going to
make consumers more knowledgable about these products so they
can have better conversations with their doctors,'' Trewhitt
said.
Under the FDA plan, means for offering more information on a
drug include providing a tollfree number, referring to print
ads or widely distributed brochures, providing an Internet Web
page, or stating that pharmacists or physicians can provide
additional information.