As drug companies blanket patients and doctors with ads touting their newest
prescription drugs, the federal agency charged with keeping them honest and protecting
the public appears to be backing off from policing those promotions.
The Food and Drug Administration demanded that companies fix distortions in
ads only 18 times this year through September, down from 64 times for all of last
year, despite rapid growth in the number of ads and leaflets promoting drugs.
In addition, the FDA is actively considering whether it should loosen rules governing
Together, critics say, these actions could put the public's health at risk
and help push drug spending - now at $154 billion - even higher as patients buy
drugs they don't need.
''There's been a dramatic drop in enforcement actions,'' said US Representative
Henry A. Waxman, a California Democrat who has protested to the Bush administration
about the trend.
''The FDA seems to be siding with the industry to give them special treatment
at the expense of the public. The public is going to be misled,'' Waxman said.
''People may end up paying higher prices for drugs that will do them less good.''
The FDA's chief counsel, however, said the agency remains committed to stopping
false or misleading advertising. Daniel Troy said advertising oversight is focusing
on fewer, more complicated cases, although he could not offer a specific example.
Troy also said he is trying to ensure that every FDA action can stand up in court.
''We are not backing off the regulation of advertising any more than the courts
compel us to,'' he said. ''Counting numbers is not in my judgment a very good
way of assessing how credible and how strong an agency is in enforcing the law.''
Some critics suggest that Troy himself is behind the decline since his office
became the gatekeeper for enforcement letters only recently and since he had challenged
the FDA's authority over some aspects of drug promotion while he was a lawyer
in private practice. Troy is also overseeing the agency's public examination of
whether the FDA's regulation of drug promotions violates manufacturers' free speech
rights. But Troy calls those criticisms ''politically motivated.''
The approximately 63 percent fall-off in FDA enforcement letters is occurring
amid a public debate over the impact of drug advertising. Drug companies spent
more than $19 billion last year to promote their drugs to consumers as well as
doctors, nearly double the amount spent just four years earlier when the FDA eased
rules on ads targeting consumers, according to IMS Health, which tracks the drug
Ads directed at consumers represented an estimated $2.7 billion last year,
and this year, the FDA is expected to review the content of a record 300 consumer
ads and more than 35,000 pieces of promotional literature. Complaints to the agency
about the content of the ads - typically from doctors, consumer advocates, or
competitors - appear fairly stable, suggesting there has been no dramatic change
in the accuracy or fairness of those ads.
At the same time, there has been a 60 percent decline since last year in the
number of all FDA warning letters for various types of infractions, from clinical
trials to marketing. These letters represent the first step in FDA policing. The
decline coincides with an order from the administration last December requiring
that Troy's office review all enforcement letters before they are sent to ensure
they consistently apply FDA rules and are legally sound. Critics say the policy,
combined with Troy's background, has had a chilling effect on FDA staff members
who monitor drug company actions.
''The FDA is supposed to be a watchdog for patients, not a lapdog for special
interests,'' said Senator Edward M. Kennedy, the Massachusetts Democrat who chairs
the Senate's health committee. ''The precipitous drop in warning letters is an
early warning signal that the administration may be planning to weaken an agency
that is vital to the health of every American family.''
Troy said his oversight is not to blame for the decrease, because his office
has rejected just 6 percent of the letters reviewed from February through September,
including only two letters on advertising.
He said he couldn't fully explain the drop-off, but contended the agency is
focusing on quality instead of quantity. ''We want to make sure what we do is
credible and legally supportable and that everyone knows we can back it up by
court action,'' he said.
However, Troy said that companies have generally responded quickly to enforcement
letters on advertising by changing the content and that they have not challenged
the letters in court. And he acknowledged that some FDA staff may be ''self-censoring.''
Protecting consumers from dishonest advertising is one of the FDA's main responsibilities
under the federal Food, Drug, and Cosmetic Act. Rules require ads to contain balanced
information about the risks and the benefits, although television and radio ads
may greatly summarize the discussion of side effects.
FDA staff members review the material, focusing particularly on ads that are
the subject of complaints, and send ''letters of notification'' or ''warning letters''
if they find problems.
One ad the FDA recently challenged promoted Lipitor, a top-selling cholesterol-lowering
drug. The FDA said Pfizer Inc.'s ad in Time and Reader's Digest falsely implied
that Lipitor was safer than its competitors. A company spokeswoman said Pfizer
revised the ad immediately.
Waxman, however, said the FDA lets some misleading claims continue, such as
a television ad that promotes the popular sleeping pill Ambien as ''working like
a dream.'' Waxman said, ''The ad underplayed the risk of addiction. '' While the
announcer says ''patients who abuse prescription sleep aids may become dependent,''
specialists who reviewed the ad for Waxman said the drug's labeling says even
those who don't abuse it may become addicted.
FDA officials declined comment on the ad, and officials at the drug company,
Sanofi-Synthelabo, did not respond to phone calls.
Dr. Peter Lurie, associate director of Public Citizen's Health Research Group,
said the drop-off in warning letters ''acts as a signal to industry that the FDA
is largely turning a blind eye to this issue,'' and he suggested that the public
''can expect a rash of more misleading advertising.''
But drug industry officials, who have long chafed under FDA ad restrictions,
say they're not trying to mislead the public or take advantage of changes at the
''Any reduction in the number of letters hasn't decreased our focus on FDA
enforcement,'' said Arnold Friede, senior corporate counsel for Pfizer.
Jeffrey Trewhitt, a spokesman for Pharmaceutical Research and Manufacturers
of America, said that lobbying group had ''not seen any decline in the effectiveness
of FDA regulation.''
Recent research has found that ads directed at consumers spur visits to the
doctor and that most patients who ask their doctors for advertised products get
Trewhitt says ''direct-to-consumer ads empower patients by enabling them to
learn about different treatment options,'' but 59 percent of the patients surveyed
by the FDA in 1999 said the ads didn't talk enough about the risks.
Meanwhile, some are concerned the Bush administration will use free speech
arguments to limit further the FDA's oversight of advertising. After a Supreme
Court ruling shot down FDA rules barring pharmacies from publicizing custom combinations
of drugs, the agency asked for public comment on its other advertising rules.
Thousands of pages of comment include a Pfizer suggestion that the agency drop
rules requiring mention of side effects in favor of a statement that all drugs
have risks and that patients should consult their doctors.
On the other side of the spectrum, Health Law Advocates of Boston argued for
rules that risks be presented in clearer voice-overs and larger type, and the
American Medical Association said the FDA should maintain strict oversight to
protect public health.
Troy said any policy changes will rest with Mark McClellan, the new commissioner.
© Copyright 2002 Globe Newspaper Company