UPDATE 1-US urges doctors to report misleading drug pitches

Tue May 11, 2010 6:53pm EDT

* 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 (Reuters) - 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 meal.

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 Program.

"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 doctor's complaint.

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 violations first.

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, Leslie Gevirtz)

Related Quotes and News

Company
Price
Related News
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
Comments (2)
HealingNews wrote:
This is where the FDA need to be concentrating, holding those pushing dangerous drugs accountable. They simply need to spend more time here, and not so much time trying to bust those selling natural supplements and vitamins known to assist in reversing or avoiding illness. www.HealingNews.com

May 12, 2010 12:12pm EDT  --  Report as abuse
VitaminD3Man wrote:
Great idea!

First and foremost have the drug companies admit they lied completely and whenever possible to mislead the public about vitamin D3 supplementation. Then have the executive management go to every household in America and tell them that, “yeah, plain old vitamin D3 would have done a he** of a lot more for your dead family member than the snake oil I was forcing on you”.

To show these quacks the country means business deny them any vitamin D3 and make them take their own nearly worthless meds(statins- a joke!).

See which group dies first for your proof.

May 12, 2010 3:24pm EDT  --  Report as abuse
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.