Watchdogs want FDA number in ads

Arguing that most Americans don't know about the FDA's adverse events reporting program, Consumers Union said DTC ads should include a toll-free number that patients can use to report side effects to the FDA.

The nonprofit presented the agency with a petition to that effect including 56,000 signatures. Consumer Reports, a publication of the group, released the results of a poll finding that of the respondents who had taken a Rx drug, 16% had experienced a serious side effect, but only 35% were aware that side effects could be reported to the FDA. 

Four out of five respondents reported seeing or hearing a drug ad within the past 30 days—nearly all on TV. Asked if ads should include reporting info, 87% said TV spots should, and 90% said print should do the same. 

A requirement that print ads include reporting info was included in last year's FDA Amendments Act. Congress ordered a study on the feasibility of such a condition for TV, but the study has not been completed. 

“You can't turn on a TV today without seeing a drug ad, but those ads never mention that consumers should be reporting serious drug side effects to the FDA,” said Consumers Union campaign coordinator Liz Foley in a statement. “What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and website in all those drug ads we're bombarded by each day?” 

The group has the support of Rep. Rosa DeLauro (D-CT), who chairs the subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies. 
You must be a registered member of MMM to post a comment.

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.