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 all respondents who had ever taken a prescription drug, 16% had experienced a serious side effect, but only 35% of all respondents were aware that side effects could be reported to 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 information, 87% said TV spots should, and 90% said print ads should do the same.
A requirement that print ads – but not TV ads – include reporting info was included in last year's FDA Amendments Act, the group noted. Congress ordered a study on the feasibility of such a condition for TV ads as well, but the study, due at the end of March, 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?”