DTC Ads to Solicit Side Effects Data?

Apr 09, 2008
By Pharmaceutical Executive Editors

Lawmakers and consumer groups are calling for all television DTC advertisements to include an FDA phone number to call in the event of an adverse reaction. But will the additional data add up to anything?or just clog the agency's phone lines?

According to the Consumers Union, which brought the idea before lawmakers last week, the additional information would provide consumers with a clear-cut place to report any side effects from medication.

The law would be an addendum to an existing legislation that mandates FDA contact info be listed on every pharma print ad. However, the Consumers Union doesn't think it's enough.

In the poll released in February by Consumer Reports (owned by Consumers Union), 35 percent of respondents said that they were not aware that they could report adverse events to FDA. Another 61 percent said that they would be more inclined to report side effects if there was a number in the television ads.

Why now?

"It's a combination of hearing about various drug safety controversies in the last few years and seeing that reporting by consumers and doctors is very low," Foley told Pharm Exec on Tuesday. "The Institute of Medicine reported in 2004 that there were only 21,000 adverse event reports from consumers and [primary-care] doctors out of 400,000 events received that year."

On Overload
Wayne Pines, former assistant commissioner of FDA and now the CEO of APCO, said that while the Consumers Union means well, FDA could never handle the potential influx of calls to its adverse events reporting center.

"FDA is on overload in adverse event reporting from manufacturers and doctors to begin with. To be put in the position where it will be receiving hundreds of thousands of calls from consumers who are not going to have the professional screening afforded by a physician, would be totally unmanageable," Pines said. "I question the viability of a system like that."

Foley argued that while most patients report adverse events to their doctor, the doctor is under no obligation to tell the FDA.

"We just hope that they do the right thing and make sure that millions more consumers know where they can report side effects," she said. "FDA needs this information, and it's only going to lead to better healthcare decisions."

Foley said that her advocacy group has had minimal conversations with FDA. She said that the Consumer Union would like all TV ads to carry a "voice-over that would state the Web site or phone number that consumers could report side effects to."

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