In a speech in Manchester, N.H., yesterday, the former North Carolina senator called for banning DTC ads for new drugs for two years and imposing new limits on what could be said in subsequent ad messages. His speech was apparently the first mention of DTC as an issue in the 2008 campaign. More than $4.5 billion is spent annually on DTC marketing, much of it on TV ads.
"A delay will ensure that well-informed doctors -- not high-paid advertising consultants -- drive prescriptions in the early phases before Americans know the full effects of new drugs," said Mr. Edwards, according to quotes from his speech released by his campaign staff.
Similar approach in '04
While in Congress, Mr. Edwards offered legislation to limit DTC. He also talked about limits when he ran for the presidency four years ago, including limits in a platform he wrote.
"The excessive costs of prescription drugs are straining family budgets and contributing to runaway health-care costs," Mr. Edwards said in his Sunday speech. Since the government relaxed direct-to-consumer advertising rules in 1997, spending on drug ads has nearly quadrupled to more than $4 billion a year.
"With such aggressive and often misleading drug-company marketing, it's too easy for advertising -- instead of doctors or proven results -- to influence families' health decisions," he said. "But the FDA has been an ineffective watchdog, reviewing only a small fraction of ads. It's time to stand up to the drug companies and their lobbyists who have rigged the system. It's time to stand strong for families, patients, and doctors."
The candidate called for increasing FDA regulation of DTC, increasing fines and limiting the claims that can be made in DTC ads.
According to a campaign fact sheet, the senator "will improve drug makers' disclosures to the public, requiring companies to tell the public the whole truth about side effects and how effective drugs are against placebos and existing alternatives. As a result, drug companies will no longer be able to advertise costly 'me-too' drugs without disclosing the existence of less costly alternatives."
The proposal did not detail how the content limits would work. The Edwards campaign did not return several calls seeking an explanation.
A bolstered FDA
Since Mr. Edwards' last campaign, Congress has enacted legislation giving the FDA more staff to review drug ads and new ability to fine marketers for deceptive advertising.
Advertising and drug-industry groups today suggested that the legislation gives the FDA additional resources and said during the Congressional debate major questions were raised on the constitutionality of imposing other limits on what can be said in ads. They also said the Government Accountability Office looked at and rejected claims that DTC was raising medical costs.
"This is disappointing in light of the careful review Congress undertook," said Dan Jaffe, exec VP of the Association of National Advertisers. "If [Mr. Edwards] becomes president, his view cannot be ignored."
Trade industry group Pharmaceutical Research and Manufacturers of America, in a statement from Senior VP Ken Johnson, noted that the group had also started a self-regulatory code in the last two years that voluntarily limits what can be said in ads. He said a moratorium on DTC "would deprive patients of valuable information about a range of medicines and their benefits and risks."