US urges doctors to report misleading drug pitches

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U.S. health officials will encourage physicians to report misleading promotions from pharmaceutical salespeople who pitch medicines in doctors’ offices or over dinner.

The effort to be 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 staffers routinely check ads on television or in magazines or medical journals, but it is tough to track closed-door pitches such as a chat inside a doctor’s office or a sales presentation over lunch or dinner.

Starting this month, the 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,” said Thomas Abrams, head of the FDA’s division of drug marketing, advertising and communications.

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 thought up the new FDA program with Dean, said the goal is to teach doctors “how to be better consumers of information they receive from the drug reps” - a skill they don’t 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.

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.

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.

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By Lisa Richwine

WASHINGTON (Reuters)

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