Identifying Deceptive Rx Advertising: FDA Rejects PhRMA's Criticisms Of Its Study

US agency disagrees that study of consumer and healthcare professional ability to detect deceptive promos is unnecessary; final guidance on product name placement in labeling and advertisements mirrors 2013 draft.

The US FDA is pushing ahead with a study of deceptive drug promotion, refuting the Pharmaceutical Research and Manufacturers of America's contention that the issue is not a prevalent problem and that evaluating the ability of consumers and healthcare professionals to detect such ads would offer "limited practical utility."

Without mentioning PhRMA by name, FDA responded to its criticisms in a discussion of comments the agency received about its proposed study, "Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion." FDA announced the research project in January, and describes its response to comments on the proposal in a Federal Register notice scheduled for publication Dec. 12. The project will consist of separate studies of consumers and healthcare professionals who will view mock pharmaceutical websites focused on chronic pain and obesity. (Also see "Rx Advertising: Can Consumers And Doctors Tell When Drug Promos Are Deceptive?" - Pink Sheet, 3 Jan, 2017.)

As to the association's claim that deceptive drug promotion is not a prevalent issue, the agency said numerous studies have examined the prevalence of false or misleading claims and presentations in direct-to-consumer advertising. The agency also noted that it frequently issues compliance letters addressing misleading claims and presentations.

PhRMA also argued that identification of deceptive promotion is FDA's assigned responsibility, not the duty of healthcare professionals (HCPs) and consumers. And it contended that whether a consumer can identify deceptive promotion is mitigated by the healthcare professional's role as the "learned intermediary."

FDA stated that as part of its mission, it is critical that its Office of Prescription Drug Promotion (OPDP) adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as the populations' processing of such claims.

"Moreover, we note that sponsors are not generally required to submit promotional pieces to FDA prior to dissemination, and limited resources prevent OPDP from reviewing all promotional materials in the marketplace," the agency said. "Voluntary HCP and consumer reporting of false and misleading promotional material contribute to the accomplishment of FDA/OPDP's mission."

Has Bad Ad Program Stalled?

In 2010, FDA launched its Bad Ad program, which encourages HCPs to report inappropriate promotional activities. And in 2013, FDA and MedScape began an e-learning course to educate HCPs and students on how to identify and report Rx drug promotion that may be misleading or raise other regulatory issues. (Also see "FDA Enforcement Letters On Rx Drug Promotions Plummet In 2013" - Pink Sheet, 1 Nov, 2013.)

In the last couple of years, the Bad Ad Program apparently has not been generating any enforcement activity. The last time the program was cited was in a 2015 warning letter about Kim Kardashian's social media postings on the benefits of Duchesnay Inc.'s morning sickness drug Dictegis (doxylamine/pyridoxine). (Also see "OMG! Kim Kardashian Social Media Post For Morning Sickness Drug Draws FDA Warning" - Pink Sheet, 11 Aug, 2015.) In 2014, one enforcement letter referenced the program and in 2013 none did.

The agency might benefit from consumers and healthcare professionals flagging improper promotions. This year, its Rx drug advertisement enforcement letters have plummeted to an all-time low of three. (Also see "Don't Sleep On DTC Compliance: FDA Dings Zolpimist Superiority Claim Vs Ambien" - Pink Sheet, 24 Nov, 2017.)

Questionnaire Revisions

FDA made minor changes to the study, including adding a question to the pretest survey asking consumers in what situations they would consider taking prescription drugs. Eli Lilly & Co. had suggested a screening question to exclude those who are opposed to taking Rx medicines.

The agency also added questions asking respondents to rate their current knowledge about prescription drugs and for HCPs to approximate what proportion of their current patients they treat for chronic pain.

The agency did not adopt PhRMA's request to change the study design regarding study stimuli. The association said it is unclear how FDA will determine that a study stimulus is deceptive. PhRMA stated that it seems unrealistic for FDA to conduct research with those who do not understand the agency's standards or have access to the training and resources of an FDA reviewer. And it asserted that whether a particular communication is false or misleading must be based on empirical evidence.

FDA disagreed that participants need to have access to the training and resources of an FDA reviewer, but it agreed that there must be validation that the study stimuli are deceptive and said the study is doing this. For example, the agency said some of the specific claims used in its experimental manipulations are established as being factually incorrect because the promoted drug is a member of a class of drugs for which the claim could not be true.

Approximately 407 firms disseminate approximately 104,358 advertisements and promotional pieces each year.

PhRMA and Lilly both stated that the study questionnaires ask leading questions. "[W]hile there are claims or presentations that can be inherently false or deliberately misleading, in most cases determining whether a claim is misleading is a subjective matter," Lilly said.

In response, FDA said it has included a mix of positive and negative statements in the questionnaire, with more positively framed items.

Novartis Pharmaceuticals Corp. proposed that additional study arms be included that explore various scenarios/websites which test both the number of deceptive claims in conjunction with the degree of deception. "For example, a single explicit lie may be more impactful than 15 implied deceptions," Novartis said. "The current study will not be able to draw any conclusions regarding that scenario."

FDA responded that while this is a viable research idea, "cost implications of creating and testing additional stimuli for this purpose bar us from pursuing it."

The cost of the study is $874,207. FDA has undertaken 43 studies of Rx drug promotion to consumers and professionals. Of these, 27 have been completed, four are pending peer review and publication and 13 are in progress.

Final Guidance On Product Name Placement Mirrors 2013 Draft

In another Federal Register notice slated for publication Dec. 12, the agency announced the availability of final guidance on "Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements." The document has been in the works for 18 years and is nearly identical to the draft guidance issued in November 2013. (Also see "FDA May Allow Fewer Mentions Of Generic Name In Drug Ads" - Pink Sheet, 18 Nov, 2013.)

The draft revised a January 2012 final guidance, which had revised the original draft issued in 1999. The agency said it had received no public comments on the 2013 draft. However, Merck submitted a brief comment asking the agency to delete the reference to a "screen" in the section on electronic and computer-based promotion and the agency did so.

The final guidance also added hypothetical examples of established name presentations that do not have commensurate prominence with the proprietary names to illustrate differences in contrast, type size, and spacing.

FDA also added "videos shown in a health care provider's office" as an example of audiovisual labeling. And in a footnote noting considerations when determining the most prominent display of the proprietary name, it added a reference to how the webpage is displayed when viewed on different devices, (e.g., desktop computer monitors, mobile devices, tablets).

The agency also replaced the phrase "FDA intends to exercise enforcement discretion" with "FDA does not intend to object" if the established name is not included in the audio portion of audiovisual promotional labeling or in audiovisual broadcast advertisement.

FDA noted that using calendar year 2015 data, it estimates that, for Rx human and animal drugs and biological products, approximately 407 firms disseminate approximately 104,358 advertisements and promotional pieces each year. It estimated that it would take third parties approximately three hours per disclosure of placement, size, prominence and frequency of product names in labeling and advertising.