WASHINGTON Complaints about drug-company marketing tripled in the past year after U.S. regulators encouraged doctors to report misleading promotions.
The Food and Drug Administration views early results from the "Bad Ad Program" as a success and plans to expand it by reaching out to medical students and more physicians.
"The program has been immensely successful. I'm very pleased to see such an overwhelmingly positive response from the healthcare community," Thomas Abrams, head of the FDA's division of drug marketing, advertising and communications, told Reuters on Thursday.
The campaign seeks to educate doctors on how to spot misleading promotions and urges reporting to the FDA by phone or e-mail. It is meant to increase regulators' reach into the largest area of prescription drug promotion -- the private contacts between drug company salespeople and prescribers that happen in doctors' offices, at hospitals or over dinner.
In the year since the Bad Ad effort launched, the FDA has received 328 reports of suspect marketing for prescription drugs and other products. That is three times higher than the yearly average of about 104 reports per year.
Healthcare providers submitted 188 of the complaints. Consumers and companies also responded to the campaign as 116 reports came from consumers and 24 from industry representatives.
Eighty-seven were considered worthy of investigation by the agency's drug ad reviewers, and five resulted in letters to companies objecting to their marketing. Some reports remain under review.
The complaints included accounts of questionable pitches from salespeople as well as online videos, a promotional magnet and other material, FDA reviewers said.
One case involved a Forest Laboratories Inc FRX.N drug for fibromyalgia called Savella. A company sales representative called a doctor's office and said the drug was useful for treating back pain and mood disorders, according to an FDA letter to Forest.
The agency said the pitch was misleading because Savella is approved only for fibromyalgia. The salesperson also made unsupported claims the drug worked better than a rival and minimized the medicine's risks, the FDA said.
Marketing violations can land companies in deeper legal trouble as several drugmakers have faced civil and criminal charges of improper marketing. Johnson & Johnson (JNJ.N), for instance, was ordered this month to pay $327 million in civil penalties to the state of South Carolina over marketing of antipsychotic Risperdal.
For the Bad Ad campaign, FDA staff promoted the effort at 15 medical conferences and sent letters to about 33,000 healthcare providers.
A survey found 30 percent of doctors were aware of the program, said Robert Dean, an FDA employee and former drug company sales representative who helped create the campaign. He said he was pleased with that figure given the initially narrow outreach but wanted it to grow.
In the coming year, the agency plans to develop an education course for doctors, nurses and pharmacists and pursue ways to reach medical students.
"We want to build this program," Dean said.
(Reporting by Lisa Richwine, editing by Matthew Lewis)