Healthy Skepticism Library item: 17766

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Richwine L
U.S. urges doctors to report misleading drug pitches
Reuters 2010 Mar 11
http://www.reuters.com/article/idUSTRE64A46C20100511

Abstract:

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

Full text:

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.