FDA takes a stand against misleading drug ads

SILVER SPRING, Md. —From sophisticated computer-generated animation to camera work worthy of Hollywood to celebrity endorsements, direct-to-consumer drug advertising has grown into a sophisticated and expensive business. But according to the Congressional Budget Office, the amount of money that drug companies spend advertising to healthcare professionals dwarfs what they spend advertising to consumers—nearly threefold. Now, the Food and Drug Administration is launching a campaign to make sure drug makers stay honest when they pitch their products to professionals.

The FDA announced last month the launch of the Bad Ad Program, an educational outreach effort administered by the agency’s Division of Drug Marketing, Advertising and Communications. The stated goal of the program is to prevent misleading prescription drug advertising.

“The Bad Ad Program will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” DDMAC director Thomas Abrams said.

The program is divided into three phases: In the first phase, the DDMAC will engage healthcare professionals at medical conventions and distribute educational materials through partnerships with medical societies; in the second and third phases, the agency will work to update the materials.

The agency’s traditional methods of monitoring drug advertising have relied on reviews of promotional materials submitted by drug companies themselves, as well as complaints and field surveillance at conventions. The agency said that while these methods are effective, it has more limited ability to monitor promotions in more private settings, particularly drug company representatives’ visits to doctors’ offices and hospitals, as well as dinner programs and promotional speaker programs.

In particular, according to the FDA, two problems that frequently occur among drug reps are overstatements of drugs’ effectiveness, such as saying a drug can work in as little as three days even though most participants didn’t show improvements for three months, or promoting drugs’ effectiveness while downplaying the risks involved.

“Companies send us their sales aids—the booklets and campaign materials for their drug that the reps are supposed to use in the field when they talk with doctors—and we review those materials,” an online FDA article directed at consumers quoted DDMAC group leader Robert Dean as saying. “But we have limited access to the promotional activities in these settings. That’s why we’re asking healthcare professionals to partner with us in our efforts to stop misleading prescription drug promotion.”

While not directly related, the program comes shortly after settlements in April between the federal government and drug makers Johnson & Johnson and AstraZeneca over alleged promotion of drugs for unapproved uses. J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced it would pay $80 million to settle allegations that it promoted the epilepsy drug Topamax (topiramate) as a treatment for unapproved uses between 2001 and 2003. The settlement was announced days after AstraZeneca agreed to pay $520 million to settle claims that it promoted the schizophrenia and bipolar disorder treatment Seroquel (quetiapine) between 2001 and 2006 as a treatment for Alzheimer’s disease, attention deficit hyperactivity disorder, insomnia and other unapproved uses.

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