FDA SAYS NO NEW RESTRICTIONS FOR DRUG ADS SOON

WASHINGTON - The Food and Drug Administration said Friday it
would not place any major new restrictions on prescription drug
advertisements aimed at consumers while the agency conducts a two-year
probe of the ads' impact on public health.

A flurry of direct-to-consumer ads hit U.S. audiences in 1997 after
the FDA changed guidelines for advertising prescription drugs.

While drug companies spent $1.53 billion from March 1998 to 1999 on
direct-to-consumer ads, health and consumer groups questioned whether
manufacturers were providing a true picture of drugs' risks and benefits.

The FDA is launching a two-year evaluation of the ads' health impact,
including whether they have informed or misled consumers or put extra
pressure on doctors to prescribe the medications.

But FDA officials say so far they have not seen overwhelming evidence
of harm when companies bypass doctors and make their pitches directly
to potential patients.

Most consumers welcome the ads as a source of health information, said
Nancy Ostrove of the FDA's marketing, advertising and communications
division.

``Consumers seem to like it,'' Ostrove said. ``They think it helps
them become educated about their medications.'' Direct-to-consumer
advertising of prescription drugs became a phenomenon in 1997 after
the FDA said it would allow manufacturers to advertise on television
without having to provide lengthy descriptions of all possible side
effects.

Instead, ads could mention just the major side effects as long as they
gave consumers options on where to find more information, including
through a toll-free telephone number, a Web site and doctors.

Friday, the FDA said it was making only minor changes to the
guidelines, such as removing the requirement that companies fax copies
of drug labels to consumers who request them.

The guidelines apply only to radio and television ads, however. The
agency said it was still reviewing its guidelines for print ads.

Advertisers welcomed the news, saying the agency had clearly decided
that drug ads were a valuable source of health information for consumers.

``The FDA did the right thing,'' said John Kamp, a spokesman for the
American Association of Advertising Agencies. ``It recognized that
direct to consumer helps inform consumers, and that's good for the
public.''

An FDA critic, Dr. Sidney Wolfe of Public Citizen's Health Research
Group, said the agency needed to adopt strong regulations that would
make sure misleading ads did not get on the air. Now, companies can
air ads without prior FDA review.

``This system isn't working at all to stop, one after another, false
and misleading television ads,'' Wolfe said. ``By the time FDA catches
up with these (ads), 10 to 20 million people have seen them.''