FDA DTC and ROI: The simmering alphabet soup of pharmaceutical consumer outreach

The New FDA: champion of DTC and of survey-guided policy input

Just a few weeks ago, the FDA closed its public comments period on a questionnaire for a survey it intends to conduct later this year among health care professionals. The goal of the survey is to gather insight on how consumer-targeted promotion ultimately impacts the quality of interactions and decisions in provider offices around the country. The instrument itself is still a work in progress, and no one will be surprised to hear that our firm made a number of friendly, civic-minded suggestions. It’s clear that FDA has become a patron of survey research for many purposes -- policy development as well as risk surveillance.

The very fact that this particular survey is on the docket speaks volumes about what many FDA-watchers have already concluded: that the agency has morphed from wary and grudging to comfortable and upbeat about the benefit of allowing pharma to converse with patients. After several decades of experience, the FDA seems ready to conclude that direct-to-consumer advertising (DTC) can do more than bring relevant therapies to broader awareness. It can also, through “fair balance,” arm patients with many of the pros and cons to promote more informed conversation with caregivers. Actually, my husband (an attorney, not a citizen of our pharma community) has often expressed astonishment that any of my clients pay to run ads on TV because he is utterly convinced that they make patients run fast in the other direction. As it happens, he is mistaken.

Pharma on Facebook: The handwriting on the wall is about more than adverse-event reporting

A bad case of “consumer package goods envy”

Pharmaceutical companies have long had a bad case of “CPG envy” because regulatory handcuffs constrain their customer outreach and limit their ability to develop brand relationships with any of their customers. Even in this golden age of “patient democracy,” pharma has no small challenge engaging with patients for a complex set of reasons – among them the rather frustrating truth that patients don’t generally care to love and know their drug brand in quite the same way they love their brand of beer. (More on that in another entry…) At the same time, pharmaceutical companies feel a pressing need to cultivate relationships with patients as a result of many factors that are redirecting their marketing efforts toward end-users – including tighter access to physicians, the coming shift in pay burden to patients, and the industry’s focus on revenue lost through non-adherence.

For that reason, the opportunity for pharma companies to talk to patients and potentially hear them talk back through social media was hard to resist – especially given FDA’s continuing refusal to offer guidance – until Facebook announced new rules of the game requiring that everything be said out loud. Companies began rather quickly to reexamine their strategy and, in some cases, shut down the conversation.