June 6th, 2008

Congress Reconsiders Curbs on DTC Ads

By Ira Teinowitz and Michael Bush
Advertising Age

Proposal to Mandate Waiting Period for New Drugs

Congress is considering new curbs on the $5.15 billion spent annually in direct-to-consumer pharmaceutical advertising. The talk of restricting DTC ads comes a little more than a year after the ad and pharmaceutical industries defeated a similar initiative.

Ad association executives expect the renewed scrutiny could lead to more hearings this year questioning DTC campaigns and a major fight early in next year’s Congress. Presumptive Democratic presidential candidate Sen. Barack Obama has already indicated support for some DTC restrictions.

Dick O’Brien, exec VP-American Association of Advertising Agencies, said ad groups are going to have to start getting busy. “We’re witnessing an encore of the attempt in last year’s Congress to severely restrict this form of advertising,” he said. “We successfully made the case then that DTC advertising is a force for good in educating the nation’s patient population—especially those who can’t afford to make regular visits to a doctor. We need to get back up to the Rayburn Building and make that case again.”

For and against
Consumer groups and some legislators argue moratoriums on advertising new drugs would provide more opportunity to discover unknown side effects. Ad groups and the drug companies argue that moratoriums are both unconstitutional and unwise, potentially leaving sick people short of information on new cures to their ailments.

A year ago, some major congressional leaders gave their support to the moratorium, pushing proposals for a two- or three-year delay on advertising of newer drugs and those deemed to carry risk. Among the leaders were Sen. Edward Kennedy, D-Mass.; U.S. Rep. Henry Waxman, D-Calif.; and U.S. Rep. Ed Markey, D-Mass. Mr. Kennedy is chairman of the Senate Health, Education Labor & Pensions Committee; Mr. Waxman chairman of the House Oversight and Government Reform Committee; and Mr. Markey, chairman of the House Energy and Commerce Committee’s telecom panel.

Ad groups won that fight when the moratorium proposal included in legislation sent to the Senate floor got pulled from the final version of the law. Now, after the House has held hearings on several drug-ad campaigns, the moratorium proposal is back and drawing some powerful new supporters.

In a letter to drug companies and the drug industry, House Energy and Commerce Committee Chairman John Dingell, D-Mich., joined Rep. Bart Stupak, D-Mich., in urging major drugmakers to voluntarily impose a two-year moratorium on advertising for new drugs. Mr. Stupak heads the committee’s Oversight and Investigations panel. A committee spokeswoman said not all the companies have responded yet and the committee wouldn’t release the responses until all arrived.

Pfizer not budging
Pfizer was one of the companies contacted by the committee. “As we have said previously, direct-to-consumer advertising is an important way to provide consumers with clear information about medical conditions and treatments and motivate consumers to have productive conversations with their physicians,” a company spokesman said.

Ken Johnson, senior VP, Pharmaceutical Research and Manufacturers of America, also stressed the DTC ads are beneficial to patients. “We question the need for a moratorium because we don’t believe that it’s in the best interest of patients. Our new DTC guiding principles say that pharmaceutical companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign. Our self-imposed guiding principles are working, and they’re working well because, in the end, patients benefit.”

Meanwhile Rep. Rosa DeLauro, D-Conn., has joined Rep. Jo Ann Emerson, D-Mo., in introducing legislation requiring a three-year moratorium on advertising new drugs. Ms. DeLauro heads the appropriations subcommittee that approves the FDA’s funding and potentially could add the requirement in language funding the agency.

While drugmakers generally give their ads to the FDA, before running the spots, they have traditionally fought any mandate that the FDA approve an ad before it runs and would not want to see any moratoriums placed on advertising new drugs.

DTC changes could also come from the states. Last month Merck reached a $58 million settlement with 30 state attorneys general over its Vioxx ads and agreed to delay advertising new pain-relieving drugs at least until the Food and Drug Administration specifically approved ads and longer if the FDA recommended an ad delay. A spokesman for Oregon Attorney General Hardy Myers said similar agreements are being sought in other cases.

Bracing for new battle
Jim Davidson, the ad industry’s lobbyist for the issue, said that the pressure is definitely increasing. “There is a serious risk that Congress will return to this issue next year and again debate the restrictions it rejected in 2007,” he said.

“I would be extremely surprised if anything happens this year, but I see this whole Congress as teeing up issues for shortly after the election,” said Dan Jaffe, exec VP of the Association of National Advertisers. 

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