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.
Without much fanfare, the FDA has also been soliciting perspectives from the industry about the impact of DTC advertising. But, as I noted earlier this year (in presenting some data at the Pharma Market Research Conference in Parsippany, NJ), the methods by which pharmaceutical companies set about measuring ROI have not been conducive to a rigorous assessment of DTC’s larger health impact -- and often not even conducive to a calculation of financial impact. Much of what we know is best described as statistical anecdote. It’s ad hoc, impressionistic, and circumstantial -- frequently conducted more in hopes of proving that DTC is a good investment rather than with intent to document the kinds of conversations and outcomes it stimulates.
For that reason, we believe the FDA is on the right track when it aims to have providers weigh in on whether DTC is advancing the cause of health care or creating obstacles. We also anticipate the FDA survey will ultimately support the conclusion that, more often than not, DTC (a) contributes to improved conversations and (b) probably promotes patient adherence and persistence more than it undermines it. I could say cynically that these FDA survey results are so far in the future that no one will ever recall this prediction if I happen to be wrong, but actually, we have some research evidence of our own to support the case. We’ll be sharing it in future blogs.
How much information is too much?
The FDA is also looking to chart the outer bounds of what consumers can effectively handle with respect to drug information and what can be done to make it easier for them to pull all the elements together in a coherent risk-benefit story. On that score, here’s another prediction, although the endpoints and the proof-points are far more elusive. The FDA will find that, beyond a certain point, more is not more. It doesn’t necessarily matter how it’s framed, how big the print, or even whether someone manages to translate esoteric side effects and statistical probabilities into fifth grade level. It’s never possible to supply complete context to a lay person (whatever the topic), so more information inevitably begs more questions. The goal of fair balance and full disclosure -- even brief summary -- is to arm patients with the right questions and prepare them to assimilate information from their providers, not to be autonomous decision-makers. Even in a clinical democracy, that level of self-determination is unrealistic.
Today’s stilted DTC monologue in the parlor versus tomorrow’s cross-talk in the great outdoors
The most important question the FDA is mulling is how social media ultimately fits within the broader information eco-system. The agency has been exposed to testimony that argues for the enormous importance of the web but has coyly left pharmaceutical companies to blaze that trail with no guidance other than conscience and broad regulatory principles. It’s easy to be sympathetic to both sides: pharmaceutical companies, who are loathe to pioneer, and regulators, who would rather take a reactive approach to oversight, learning empirically by watching companies muddle through.
Ultimately, though, if we read between the lines or squint at the horizon, we have to see that the FDA will soon expect a significant amount of interaction between patients and manufacturers in the open spaces of the worldwide web. The web is now the most important source of information about nearly every single thing we care to know about, so consumers need to be directed to well-curated company websites that are organized to deliver accurate, accessible, and meaningful information on all drugs, for those who seek it out.
Meeting full disclosure obligations by sending consumers from TV commercials to print ads in narrowly targeted publications doesn’t do the trick. If pharmaceutical companies are going to speak to consumers and patients, they will need to do it in the place more of them hang out, not in cubbyholes like Golf Digest.
Pharma-sponsored web sites must not be static and impermeable but neither can they follow the current social media model. Pharma companies need literally to invent a way of interacting with the patients they serve. The FDA is neither prepared nor equipped to do it for them. But we think they very much want it to happen.