DTC regulation by FDA debated

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Direct-to-consumer drug ads proved a prescription for debate last week as a U.S. Senate committee took Congress's first extensive view at the rise in DTC ads. But there's little indication there will be action this year.

Consumer groups told a Commerce Committee panel that the sharp rise in prescription-drug consumer advertising is causing such a big increase in health-care costs and unnecessary medication that marketers should face bigger financial penalties and possibly criminal prosecution for their misleading ads.

Industry supporters said DTC drug ads help patients become more knowledgeable and increase the chance they will take their medicine and go to their doctors, lessening long-term problems and cutting health-care costs.

As a result of changes by the FDA, U.S. DTC advertising has exploded over the past four years into a $2.5 billion category in 2000, according to IMS Health, a research firm. There are, though, signs spending growth is slowing (AA, July 23).

Sidney Wolf, director of Public Citizen's Health Research Group, said the FDA needs more staff and bigger weapons, including possible criminal sanctions and higher fines to punish marketers who repeatedly run "illegal" ads.

"The present situation concerning DTC advertising is unacceptable," he told senators at the hearing.

Unless the FDA can levy heavy fines on repeat violators of advertising rules, drug companies "will just laugh" at the regulation, he said.

Nancy Chockley, president of the National Institute for Health Care Management Foundation, said the 50 most heavily advertised drugs last year saw sales increase 32%, compared with 14% for other drugs. She noted one recent study suggested that 70% of consumers who ask a doctor for a medication get it. "Advertising works," she said.

Richard Dolinar, an endocrinologist, however, told the panel that DTC is helping patients.

"Direct-to-consumer advertising is getting patients with diabetes into my office sooner so they can be treated," he said, adding that the ads empower consumers and also remind them to take their medicine.

Spokesmen for the American Enterprise Association, a conservative think tank, and the Pharmaceutical Research and Manufacturers of America, a drugmaker trade group, urged against changes and said consumers "like" the ads.

The FDA said it has no evidence the ads prompt unwarranted medication. Nancy Ostrove, deputy director of the FDA's office of drug marketing, advertising and communication, said it's hard to "tease out" the ads' effects because marketers accompany their consumer campaign with doctor promotions that could be causing the sales boost.

Senators expressed concern about whether the FDA had adequate staff to enforce existing DTC ad rules and about whether the ads were causing doctors to medicate needlessly.

"I am concerned that DTC may have stimulated more demand than would be optimal," said Sen. Peter Fitzgerald, (R., Ill).

Despite their criticism, the senators showed little appetite for significantly changing rules, at least until there is further research indicating the ads' effects.

Sen. Byron Dorgan, (D., N.D) who chaired the Commerce Committee panel, told Advertising Age the hearing was "informational" and ruled out proceeding with the kind of legislation U.S. Rep. Pete Stark, (D., Calif.) has introduced that would impose taxes on DTC ads that didn't balance favorable information on drugs with drug-risk information. Sen. Dorgan said he wanted to "evaluate" the testimony and determine "what, if anything" the committee would do next.

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