* FDA seeks help checking pitches in doctors' offices
* Agency aims for largest area of drug promotion
(Adds AMA, consumer, drug industry quotes)
By Lisa Richwine
WASHINGTON, May 11 U.S. health officials are
encouraging physicians to report misleading promotions from
pharmaceutical salespeople who pitch medicines in doctors'
offices or over dinner.
The effort announced on Tuesday aims to increase
regulators' reach into the largest area of prescription drug
promotion -- the private contacts between drug company
salespeople and prescribers.
The law requires prescription drug marketing to be truthful
and balanced. Food and Drug Administration staff routinely
check ads on television or in magazines and medical journals,
but it is tough to track closed-door sales tactics such as a
chat inside a doctor's office or a sales presentation over a
Starting this month, FDA staff will set up booths at major
medical conferences to tell doctors how to spot questionable
pitches. The agency also is sending a letter to about 33,000
healthcare providers about the campaign, dubbed the Bad Ad
"We are asking doctors to increase their awareness and
report questionable activities to us," Thomas Abrams, head of
the FDA's division of drug marketing, advertising and
communications, told Reuters.
The idea came from two former drug company pitchmen who now
work in the FDA office that polices promotions.
After joining the agency as ad watchdogs, the pair realized
"we don't really have a presence out in the field where we used
to work," said Bob Dean, one of the FDA employees who helped
create the program.
Drug companies make major investments in promoting drugs
directly to doctors, a practice called detailing. The industry
spent nearly three times more -- $12 billion -- on detailing as
it did on ads aimed at consumers in 2008, the Congressional
Budget Office found.
The FDA under President Barack Obama has vowed to boost
enforcement against drugmakers and others. Warnings to
companies for problematic promotions nearly doubled in the year
after Obama took office.
Mike Sauers, who with Dean thought up the new FDA program,
said the goal is to teach doctors "how to be better consumers
of information they receive from the drug reps" -- a skill they
do not typically learn in medical school.
Some violations "are obvious," Dean said. "Complete
omission of risks would be an easy one to spot. Minimizing
risks also would be an easy one."
Physicians can report anything questionable via an FDA
phone hotline or e-mail.
Dr. Rebecca Patchin, the American Medical Association's
board chair, said doctors frequently voice concerns to the
group about misleading drug promotions. The FDA program "is a
helpful avenue for physicians to bring these activities to the
agency's attention," she said.
FDA staff would need to verify complaints before taking
action. The agency sends letters to companies when it finds
misleading promotions telling them to stop, and sometimes
orders distribution of corrective messages.
While it might be hard to tell exactly what was said in a
private meeting, FDA reviewers will be able to spot patterns
when they hear similar complaints about the same drug from more
than one doctor, Dean said.
"If there is some promotion going on that is questionable,
it will surface in multiple places," he said. Abrams said his
staff will look at related marketing for a drug beyond a
Consumer advocate Diana Zuckerman said she was pleased the
FDA was making it easier to report improper promotion.
"But the real problem is what will the FDA do about bad ads
that have been reported, and how long will it take them to do
anything useful?" said Zuckerman, president of the National
Research Center for Women & Families.
She and others say the agency takes too long - often months
- to respond to improper marketing. The FDA's Abrams said the
agency uses its limited resources to focus on the most serious
Dr. Jerry Avorn, a professor of medicine at Harvard Medical
School, called the FDA program a "clever idea, especially in
lean fiscal times" that would help detect problematic
promotions. But he said the agency needed adequate funding from
Congress to act on all the complaints that might come in.
In the FDA's letter to doctors about the new campaign, the
agency said responsible promotions can provide doctors with
valuable information about new therapies. "But when these
promotions mislead they can deceive you, your colleagues, and
eventually may deceive patients," the letter says.
The drug industry said it was committed to truthful
promotions to consumers and doctors.
"Companies devote substantial time and effort, and often
ask for input from the (FDA) to ensure that prescription drug
communications are accurate and meet all applicable legal
requirements," said Ken Johnson, a spokesman for the
Pharmaceutical Research and Manufacturers of America.
The FDA announcement is "another step to help educate - and
receive feedback from - healthcare providers about prescription
drug advertising and promotion," Johnson said.
The FDA posted details at www.fda.gov/badad.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick,