Yesterday I noted that there were letters flowing down from the Hill to manufacturers regarding some specific examples of Direct-to-Consumer (DTC) ads that were of interest to various members for various reasons. Today, the Los Angeles Times carries a report of a different focus on DTC.
Representatives Rosa DeLauro (D-CT) and Jan Schakowsky (D-IL) have issued a call for the FDA to require manufacturers engaged in DTC to include running a toll-free telephone number in advertisements to provide consumers with a means to report an adverse event with the drug.
The basis for this call to action is a Consumers Union survey that found while 16% of patients said they had experienced an adverse event, only 35% of them were aware that such an event could or should be reported. While that should not be a surprise to anyone given the fact that just about everyone agrees that adverse events are under-reported, the statistic certainly gives one pause and, if the FDA doesn’t act on this, one can expect to see it among the many reforms that are coming down the Hill aimed at the FDA.