Edwards Tackles Prescription Drug Ads as Campaign Issue

By Ira Teinowitz

Democratic presidential hopeful John Edwards, a frequent foe of direct-to-consumer prescription drug ads in the past, is reviving the issue on the campaign trail.

In a speech Sunday in Manchester, N.H., the former North Carolina senator called for banning DTC for new drugs for two years and imposing new limits on what could be said subsequently.

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,” the campaign quoted the former senator as saying.

While in Congress, Sen. Edwards offered legislation to limit DTC. He also talked about limits when he ran for the presidency four years ago and included limits in a platform he wrote.

In quotes from his speech Sunday provided by the campaign, Sen. Edwards blamed DTC for some of the high cost of healthcare.

“The excessive costs of prescription drugs are straining family budgets and contributing to runaway healthcare costs,” he said. “Since the government relaxed direct-to-consumer advertising rules in 1997, drug ads have nearly quadrupled to over $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.

“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.”

He called for increasing regulation by the Food & Drug Administration regulation of DTC, increasing fines and limiting the claims that can be made in such ads.

A campaign fact sheet said 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.

Since Sen. Edwards’ last presidential campaign, Congress has enacted legislation giving the FDA more staff to review drug ads and a new ability to fine marketers for deceptive advertising.

Advertising and drug industry groups today suggested the legislation gives the FDA additional resources and said that, 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 increasing medical costs.

“This is disappointing in light of the careful review Congress undertook,” said Dan Jaffe, executive VP of the Association of National Advertisers. “If he becomes president, his view cannot be ignored.”

Pharmaceutical Research & Manufacturers of America, in a statement from Senior VP Ken Johnson, noted the group had started a self-regulatory code in the last two years that put voluntary limits on what can be said in the ads.

He said a moratorium on DTC “would deprive patients of valuable information about a range of medicines and their benefits and risks.”

“DTC ads have been shown to play a key role in educating patients, improving patient understanding of disease and available treatments and fostering strong relationships between patients and their healthcare providers,” Mr. Johnson said. “Because of the value of the advertising, PhRMA member companies are committed to providing accurate, educational information to patients and health professionals about their medicines.”