July 21, 2005

Drug makers develop voluntary ad principles

By Lisa Richwine

WASHINGTON (Reuters) - A drug industry lobbying group
responded to a growing backlash against consumer-directed
advertisements on Thursday by setting voluntary guidelines they
said would make the ads more educational and balanced.

The "guiding principles" state that ads aimed at consumers
"should be accurate and not misleading, make claims only when
supported by substantial evidence, reflect balance between
risks and benefits and be consistent with (Food and Drug
Administration)-approved labeling."

The guidelines also encourage companies to discuss new
medicines with physicians before starting ads for consumers, to
promote "health and disease awareness" in their ads and to
target them to appropriate audiences and age groups.

The announcement follows criticism from some patients,
doctors and lawmakers that companies inundate consumers with
glitzy television and magazine ads that glorify drug benefits
while minimizing potential side effects.

Some critics partly blame the ads for unnecessary
prescribing of medicines such as Merck & Co. Inc.'s Vioxx, an
arthritis drug the company withdrew last year after a study
showed it raised heart attack and stroke risk after 18 months
of use.

Pharmaceutical companies spent $3.3 billion on ads aimed at
consumers in 2003, according to medical data company IMS

The new ad guidelines received preliminary approval from
the board of the Pharmaceutical Research and Manufacturers of
America, the U.S. lobbying group known as PhRMA, President and
Chief Executive Billy Tauzin said in a statement.

Once the language is finalized, each company will decide
whether to follow the principles, PhRMA said.

"By approving these principles, the industry is
demonstrating its commitment to direct-to-consumer advertising
as a way to encourage doctor-patient discussions and provide
patients and consumers with accurate, accessible and timely
health information," Tauzin said.

A consumer activist said the guidelines basically reflect
current law that says drug ads must be accurate.

"PhRMA is not really touting anything that is going to make
a substantial difference in (direct-to-consumer) ads. What they
are trying to do is avoid real legislative reform," said Rob
Schneider, director of prescriptionforchange.org, a project of
Consumers Union.

Consumers Union supports legislation that would require
regulatory screening of some ads before the public sees them.

PhRMA's statement said its principles "go beyond current
FDA regulations." Spokesman Ken Johnson said he could not
provide details until early August after the final wording is

The group "is still working on a mechanism to receive
comments and complaints from the public and other health-care
professionals," Johnson said.