Aug. 22, 2017 – In the wake of an FDA study showing that consumers recall risk information better when they are not inundated with a comprehensive list of risks in direct-to-consumer (DTC) ads, the agency is establishing a public docket “to assist with its development of recommendations” in this area. The FDA’s Office of Prescription Drug Promotion (OPDP) is exploring the effectiveness of a “limited risks plus disclosure” strategy.

“Although it’s hard to criticize FDA’s OPDP for creating policy in a way that is generally preferable (creating a public docket and soliciting comments), sometimes bold action is warranted. In this case it’s obvious that the existing disclosures are counterproductive,” said Coalition for Healthcare Communication Executive Director John Kamp. “Every professional advertiser knows that short, simple messages are better understood and retained than complicated ones.”

According to Coalition Executive Committee Chair Sharon Callahan, CEO, TBWA WorldHealth, Omnicom, the direction the agency should take is clear. “It’s pretty simple,” Callahan said. “If you want to talk to lawyers, talk like a lawyer. If you want to talk to people, talk like a person.”

Specifically, the OPDP is accepting comments on the content of risk information in DTC broadcast ads, and is asking for feedback on eight questions, according to a notice in the Aug. 21 Federal Register (https://www.gpo.gov/fdsys/pkg/FR-2017-08-21/pdf/2017-17563.pdf):

1. 1. What data are available regarding the impact of the current approaches to communication of risk information in DTC prescription drug broadcast advertisements on consumer comprehension of the information in the advertisement, including the impact on comprehension of product benefits and risk information?
2. 2. What are the potential effects of only including risks from the FDA-approved product labeling that are severe, serious,or actionable(which the agency defines in the Aug. 21 notice) in the major statements of DTC prescription drug broadcast advertisements? Are there other ways of characterizing which risks should be included in the major statement?
3. When a DTC prescription drug broadcast advertisement presents information relating to the effectiveness of a prescription drug that does not have severe, serious, or actionable risks, what types of risk could be included in the major statement?
4. What criteria should be used to distinguish risk information that is most material to patient or consumer audiences versus risk information that is material primarily to the prescriber or other health care providers? What data are available to answer this question?
5. What criteria should be used to determine which risk information that is material to patient or consumer audiences to include in the major statement for DTC prescription drug broadcast advertisements to best protect the public health? What data are available to answer this question?
6. What is the potential impact of including (or conversely, of not including), in the major statement for DTC prescription drug broadcast advertisements, additional language that states that there are other risks not included in the advertisement while simultaneously encouraging dialogue between patients and their health care providers? (For example, additional language could include, “This is not a full list of risks and side effects. Talk to your health care provider and read the patient labeling for more information.”) What data are available to answer this question?
7. What data are available on consumers’ comprehension of the difference between levels (i.e.,severity) of risk? Would it be in the interest of public health to include a signal before the risk information that frames and categorizes the overall level of risk associated with the product? One approach may be to include an opening statement tailored to the risk profile of the drug. For example, drugs could be divided into three defined categories and include the corresponding opening statements: (a.) For drugs with severe,life-threatening risks: “[Drug] can cause severe, life-threatening reactions. These include …”; (b.) For drugs with serious but not life-threatening risks: “[Drug] can cause serious reactions. These include …”; or (c.) For drugs with no severe or serious risks: “[Drug] can cause reactions. These include ….”
8. Should potential food and drug interactions be disclosed in DTC prescription drug broadcast advertisements, and if so, what criteria should be used to identify these interactions?

Some members of industry are calling on the FDA to pull back on doing more studies, rely on its own previous research, and take action to make changes that are clearly needed. Earlier this month, the agency received several comments from industry on its study of the “utilization of adequate provision among low to non-Internet users.”

“At times, FDA proposes new studies seemingly without fully appreciating its own research,” said an Aug. 11 comment from the Pharmaceutical Research and Manufacturers of America (PhRMA). “Proposed studies are often unnecessary in light of existing data.” PhRMA further stated that the utilization research proposed “appears to offer limited practical utility,” among other points.

A comment on this study from Eli Lilly and Co. states that “whatever improvements the FDA proposes, clearly all stakeholders would most benefit if regulations are revised accordingly, which may then result in reduced numbers of rules and the removal of obsolete or conflicting requirements and guidance, clarifying the paths forward to more optimal ways to communicate risk information in DTC advertising within its limitations.”

Industry’s frustrations with the slow pace of progress in this area also may be reflected in the patient population. An FDA-funded study released last month concluded that a revised, briefer risk statement in broadcast DTC ads improves risk and benefit recognition and risk recall. “Consumers now are often intimidated, put off and confused by the existing ads and the FDA study reiterated this in academic terms,” Kamp noted. “Wouldn’t it be better, in this case, just to get on with it and enable clearer, more consumer-friendly ads?”