The latest from DTC Perspectives

AMA Advocates Pre-Approval

At a Congressional hearing last month, American Medical Association president-elect Nancy Nielsen, MD, said the association supports giving FDA the resources and authority to require DTC ads to be pre-approved by the agency.

• "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," Dr. Nielsen told a House subcommittee. "Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs."

Nielsen also noted that the AMA wants to work with Congress to ensure "that direct-to-consumer advertisements focus on truly helping patients rather than maximizing pharmaceutical companies' bottom line." In response to a question from subcommittee member Rep. Joseph Barton (R-Texas), Nielsen said "as long as it is legal to do direct-to-consumer advertisements, then it is very important that [the ads] not be misleading to the public. There has to be regulation." When she was asked if the AMA intended to say the current FDA Amendments Act isn't strong enough, her response was confusing. She said, "That is our policy and it is not targeted against any specific ads."

At that point, Rep. Barton said he "respectfully disagreed" with the AMA's position. And he added, "I don't consider this [DTC advertising] to be the most pressing issue before this subcommittee…. I am a strong supporter of aggressive oversight and investigation, [but] I would hope that some of the other issues that are ongoing, including our foreign food inspections, would perhaps take a little higher priority."

DTC INSIGHT

* Barton raised an important consideration with subcommittee chairman Stupak on why the committee was devoting time to DTC when other safety issues are clearly more important to consumers. Stupak's response indicated that he's not ready to back away from further investigation of pharmaceutical marketing. He could be a thorn in the pharma's side for several more years.