HE Food and Drug Administration is asking the
makers of prescription drugs to shun the obfuscation, so to speak,
by proposing revisions of its regulations on advertising directly to
consumers. The proposals encourage the ads to describe significant
risks the drugs may pose in language that is clearer and easier for
patients to understand.
The most notable aspect of the proposed changes, among several
announced yesterday after months of study by the F.D.A., is the
potential replacement of full-page advertisements for prescription
medications in newspapers and magazines that now detail, in small
type, information about effects and effectiveness.
Including such information is the quid pro quo drug makers must
accept if they want to run ads promoting products for specific
treatments in publications that are read by consumers rather than
health care professionals. It is the print equivalent of the
announcer in televised drug commercials who lists the risks in
soothing tones at odds with the nature of the words.
The F.D.A. commissioner, Dr. Mark B. McClellan, suggested that
drug makers produce ads that are more reader friendly by
concentrating on the most common or important side effects. For
instance, print ads might summarize the most important risks in
bigger type highlighted by bullet points.
"The general idea from all our research is that less may be
more," Dr. McClellan said in a phone interview before he described
the proposals at a news conference in Washington.
"The goal here is to make sure the F.D.A. is doing all we can to
make sure prescription drug promotion is as clear as possible," he
added. "If we're going to have advertising, people must come away
with a clear sense of what the risks and benefits are."
Critics of letting drug makers pitch prescription products to
consumers as well to doctors are worried, however, that the concept
of less being more could end up being, well, less.
"I would be in favor of it if the F.D.A. also required as it does
now the full labeling," said Dr. Sidney M. Wolfe, director of the
Health Research Group at Public Citizen in Washington, an advocacy
organization, referring to the patient information. "I'm worried
about taking out the full labeling."
The proposed changes would update guidelines issued by the F.D.A.
in 1999 to address prescription drug advertising directed at
consumers, which has grown into a $2.6-billion-a-year business.
Studies done by advertising agencies and media companies, as well
as by government agencies and drug companies, have found that
allowing such ads encourages consumers to ask their doctors about
conditions, to get treatment for problems and to take prescribed
medications as directed.
But research has also found that drug ads prompt some consumers
to ask for treatments they may not need, which may be prescribed by
doctors reluctant to deny patients what they ask for. Advocacy
organizations have complained that many direct-to-consumer ads play
up the potential benefits of expensive prescription drugs while
playing down their possible harmful effects.
The changes affecting the print ads "sound like a great idea, but
they could open the door to abuse," said Representative Henry A.
Waxman, a California Democrat who complained last week that the
F.D.A. was dragging its feet on enforcing regulations already in
effect.
"If consumer warnings about 'acute liver failure' are replaced by
language saying 'it can affect your liver function,' that's not
consumer friendly," Mr. Waxman said. "That's misleading the
consumer."
Executives at associations representing advertising agencies and
marketers were more sanguine about the proposals, which were issued
by the F.D.A. in draft form for public comment.
"The new guidances are exactly the kind of leadership we like to
see from a regulatory agency," said Adonis Hoffman, senior vice
president and counsel at the Washington office of the American
Association of Advertising Agencies.
