What's on your list of FDA spending priorities? According to report in the Pink Sheet, the Wizards of White Oak are currently spending just south of $10,000,000 on 11 research projects -- 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 $10,000,000 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 Tom 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 research rather than better guidance (per Francer)?
Tom 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 10,000,000 take us? Will they 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 they be a tipping point, with politicians and the public zeroing in on aggressively targeted DTC in print, on TV … and online?
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.”
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FDA DTC Advertising Research Projects Underway |
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Project |
Cost |
Objective |
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Quantitative Effectiveness Information in Television and Print Advertisements |
$1,026,555 |
Examine whether adding placebo information and whether changing the framing of the information helps consumers understand risk information. Also examine how physicians use the prescribing information documents and assess efficacy information. |
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Composite Scores |
$356,082 |
Determine whether consumers understand composite scores (overall score of drug’s affect on multiple symptoms) as currently communicated and how best to communicate these scores to lay audiences.
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Disease Information in Branded Promotional Material |
$1,500,000 |
Investigate the effects of adding disease information to promotional materials on consumer perceptions and understanding. |
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Effect of Promotional Offers in Print Advertisements on Consumer Product Perceptions |
$924,365 |
Examine what impact, if any, the presence of coupons in DTC ads may have on consumers’ recall and perceptions of product risks and benefits, and the overall impression of the product in full-product and reminder ads. |
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Comparative Advertising |
$1,482,034 |
Determine how consumers interpret and react to DTC comparative drug ads. |
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Corrective Television Advertising |
$386,286 |
Evaluate how corrective DTC Rx drug advertisements impact consumer perceptions |
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Online Promotion |
$2,019,620 |
Test different ways of presenting Rx drug risk and benefit information on branded drug websites. |
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Brief Summary Format Variations in Print Advertisements |
$296,509 |
Determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. |
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Healthcare Professional Survey |
$364,588 |
Follow-up to 2002 physician survey, it is designed to explore the opinions and perceptions of physicians, physician assistants and nurse practitioners regarding promotion of Rx drugs to consumers and health care providers. |
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Patient Information Prototypes |
$1,613,294 |
Test two different formats for presenting patient medication information to patients when they retrieve their prescriptions. |
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Risk and Benefit Perception Scale Development Focus Groups |
Not Available |
Develop and validate risk and benefit perception scales and explore various methods for measuring recall and comprehension. |
