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.