WASHINGTON — Hoping to head off tighter federal
regulation, the pharmaceutical industry announced voluntary curbs
Tuesday on consumer advertising, particularly television ads that
critics say are skewing medical decisions, glossing over risks and
helping to drive up the cost of prescription drugs.
The 15-point plan, announced in Dallas by the main drug industry
lobbying group, calls for making sure doctors are fully informed about a
new drug's risks and benefits before a public advertising campaign is
launched. It would also eliminate one type of commercial — the brief,
so-called reminder ad that mentions a drug by name but makes no
reference to possible risks. And, responding to complaints that children
are inappropriately exposed to ads for erectile dysfunction drugs such
as Viagra, the plan effectively would keep such commercials off programs
most likely to be watched by children.
It was not clear, however, whether the industry's
relatively modest steps would be enough to hold off growing complaints
by some lawmakers, consumers and physicians. The Food and Drug
Administration said it was beginning a review of the effect of drug
advertising, but it set no timetable for completing it. And some members
of Congress have urged stronger measures.
The plan stopped short of setting a specific waiting period before a new
drug can be advertised to consumers, a step many consider to be a
crucial reform. Experts say that would allow more time to detect rare
but dangerous side effects that might not emerge in limited pre-approval
clinical trials. Some critics, including Senate Majority Leader Bill
Frist (R-Tenn.), have called for a voluntary two-year waiting period.
In a statement Tuesday, Frist said he hoped individual drug companies
would seriously consider adopting such a policy. And he refused to rule
out congressional intervention.
Defending the industry plan, Karen Katen, a Pfizer Inc. vice chairwoman
who was closely involved in drafting the advertising code for the
Pharmaceutical Research and Manufacturers of America, an industry group,
said, "The heart of the [matter] is that the public wants to see
some changes in our ads while preserving the educational benefit of
engaging the consumer."
One frequent industry critic, Dr. Sidney Wolfe, head of Public Citizen's
Health Research Group, a consumer advocacy organization, dismissed the
plan as an industry ploy, saying: "When I saw these guidelines,
what it brought to mind was a misleading direct-to-consumer ad. The
guidelines appear to be more effective than they really would be."
Though less dismissive than Wolfe, some academic specialists said they
were disappointed. "My own view is that it hasn't gone far
enough," said Dr. Brian Strom, chairman of the biostatistics and
epidemiology department at the University of Pennsylvania School of
Medicine.
"I say to my patients, 'You see those drugs on TV? Those are the
ones you don't want,' " Strom said. "If you needed them, I'd
be prescribing them to you. You don't want them if they're not
absolutely critical for you and they're demonstrably better than the
older drugs."
Drug ads on television are a relatively new phenomenon. Traditionally,
the pharmaceutical industry pitched its products primarily to the
medical profession. Ads meant for consumers were published mainly in
magazines, with a section in fine print covering possible risks. In
1997, the FDA eased rules that required detailed listing of side
effects, opening the way for broadcast commercials.
The industry's promotional budget took off, and it has risen almost
fivefold since the late 1990s, to more than $4 billion. The growth in
spending on advertising outpaced steady increases in the companies'
research budgets.
"I think this is a huge issue that gets right at the roots of our
society," said Dr. Raymond Woosley, president of
the C-Path Institute, an Arizona nonprofit organization that seeks to
improve the process for developing drugs. "We are a science-based
nation, and we should have more respect for the science of pharmacology
and medicine than to think we can peddle it over the airwaves. I've been
in medicine for 35 years, and I still find it very difficult to answer
questions about risks and benefits. Try putting it in a 30-second
spot."
Research has shown that doctors are more likely to prescribe medicines
if patients ask for them by name as a result of advertising.
Beyond purely medical considerations, that trend raises economic
concerns among federal officials responsible for huge health programs
such as Medicare, which is adding an outpatient prescription benefit
next year.
"Drug advertisements fuel America's skyrocketing prescription drug
costs," Frist, a heart surgeon by training, said in a speech last
month. "They influence consumer behavior. And they influence
physician behavior. They cause more people to take prescription drugs.
They create an artificial demand."
But they also represent a form of speech that may be protected under the
Constitution. Government-imposed advertising bans will probably be
struck down in court, said Marc Scheineson, a former senior FDA lawyer
who now represents industry clients.
In the past, voluntary efforts by the industry have succeeded in curbing
improper promotional payments to doctors, Scheineson said. The new
advertising policy "represents a platform on which you can build.
"You have to start somewhere with principles that can get industry
consensus and compliance."
Said W.J. "Billy" Tauzin, a former congressman who is now the
drug industry's top lobbyist: "We are in a free-speech area.
Voluntary codes tend to be the best way to handle these things. So what
we've done is set up a good, strong voluntary code."
More than 20 major manufacturers have endorsed the policy. Although it
is not scheduled to take effect formally until January, Tauzin said,
consumers should start to notice changes in advertising right away.
Generally speaking, he said, ads will be more balanced and informative.
PhRMA, as the industry trade group led by Tauzin is known, will enforce
the code by setting up a compliance office to act on complaints from
consumers and doctors. But the main responsibility will rest with
individual companies.
There will be no list of programs for which ads for sexual-enhancement
drugs would be inappropriate. Instead, companies will have to research
audience data and limit such ads to programs "reasonably
expected" to draw an audience of which 80% are adults, the trade
group said.
The policy also calls for companies to submit ads to the FDA with
sufficient lead time for the agency to review them, but it's not clear
how that would work, given that the agency is short-staffed.
The FDA received about 40,000 ads for review in 2002 but has only 40
people to scrutinize them, Frist said.
Tauzin said the key to the new approach was that companies would now
take enough time to fully inform doctors about the benefits and risks of
a drug before promoting it to the public. The length of time will vary
with the kind of drug that's involved; one manufacturer has committed to
an advertising moratorium for new drugs of at least one year.
Strom, the University of Pennsylvania doctor, said restrictions on
advertising should be lifted not when companies have educated doctors
about a new drug but only after they have conducted follow-up studies to
detect rare side effects.
He has proposed a system of conditional approval, under which
advertising restrictions would be eased based on patient safety data.
"Right now, we have major incentives for industry not to do
[post-approval] studies," Strom said.
"If you had conditional approval, and the conditions are not lifted
until the data is complete, suddenly the financial incentives would be
reversed."