I'll take DTC for $10 million, Alex
What's on your list of FDA spending priorities? The Wizards of White Oak are currently spending just south of $10 million on 11 research projects for the Office of Prescription Drug Promotion (OPDP)—including a $2-million study of online prescription drug promotion.
According to OPDP panjandrum Tom Abrams, “Our objective as an agency is to increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions.”
First, let's look at the record.
OPDP receives 6,000 to 8,000 advertising and promotional submissions each month, which are assigned to one of OPDP's 32 reviewers. Per Tom Abrams, the office gets about 120 complaints about promotional materials each year from physicians, consumers and pharmaceutical companies, and of these about 45 concern DTC ads. In 2012, OPDP issued 10 untitled and warning letters for DTC promotions.
Are 10 letters worth $10 million in sparse agency resources? Well, where you stand depends on where you sit.
In the view of Jeff Francer, PhRMA's assistant general counsel, research activity is taking place “when many stakeholders are asking for regulatory guidance.” There is a “question as to how OPDP is spending its resources.”
As for the value of FDA's DTC ad research, Francer said it is unclear to him what benefit it provides.
That's a fair question. If, as Abrams said, the objective of the studies (and hence the justification for the spending) is to “increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions,” then why isn't the agency working with industry (where the expertise and experience resides) rather than going it alone? If the goal is to increase compliance, then why engage in research rather than work toward better guidance, the question implied by Francer?
Abrams equates “increased quality” with accurate, non-misleading information. And that's important. But it's the second part of his definition that should provide a pause for reflection. Consider, “ … instead provide patients with good information about prescription drugs and medical conditions.” Many (if not all) companies that advertise prescription drugs would (and should) argue that their advertisements do precisely that.
Can industry do better? Yes. Should they do better? Yes. Will these OPDP studies help them do better? That's the question on the table—and it's an open one.
At the end of the day, “in compliance” and “in the best interests of the public health” must not be mutually exclusive—indeed they should me mutually supportive.
Where will the FDA's $10 million take us? Will it be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative and allotting more media dollars for help-seeking advertising? Or, will it be a tipping point, with politicians and the public zeroing in on aggressively targeted DTC in print, on TV, online, via mobile apps?
Working together with industry, FDA can make a difference. Together, industry and FDA can evolve DTC communications into a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality. Because “an educated consumer is our best customer.”
Peter Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.