Non product specific, non accredited education programs focusing on disease state awareness are one of the most recent additions to pre-launch pharmaceutical marketing. These programs target both providers and consumers and an important part of a company’s mandate in helping the system understand diseases that until recently have few treatments such as Atrial Fibrillation and Gout.
Last week, Arnie Friede, former Food and Drug Administration (FDA) Associate Chief Counsel, and former Senior Corporate Counsel for Pfizer, Inc., gave a presentation regarding how to “Understand the Jurisdiction and Work Within the Guidelines of the Division of Drug Marketing, Advertising and Communications (DDMAC). The program, which was moderated by Ed Silverman, editor of Pharmalot, examined recent FDA Warning Letters; preapproval communications by clinical investigators not acting on behalf of a sponsor; medical-to-medical communications that FDA re-characterized as “promotional” speech; and two other examples of FDA’s broad assertion of its jurisdictional reach.
Friede also discussed how the FDA does not have regulatory jurisdiction over disease awareness communications that do not promote a specific product. He recognized how disease awareness communications effectively amount to “scientific speech” that is protected by the first amendment and beyond the scope of FDA’s jurisdictional reach. However, due to recent cases, his presentation examined the implications of FDA determining whether a communication by a drug manufacturer is “promotional” versus “disease awareness.”
To help explain these recent developments, he discussed FDA oversight of affirmative representations in terms of substantial evidence. This included the disclosure of risk information, which includes a brief summary and fair balance, as well as the “off-label” promotion potential, and the 2253 Requirement.
Although FDA acknowledges that disease awareness communications are not subject to requirements of the Federal Food, Drug, and Cosmetic Act, the grey area of interpretation “comes in how FDA defines disease awareness communications that are beyond its reach.”
FDA’s defines disease awareness communications as those “that discuss a particular disease or health condition, but does not mention any specific drug and does not make any representation or suggestion concerning a particular drug. While the first requirement is clear, FDA has not given specific instruction about what any “representation or suggestion” exactly means.
As a result of this uncertainty in FDA regulation, Friede gave examples of situations where FDA may find that a supposed disease awareness communication is “promotional.” For example, he described the practice of “bookending,” in which disease awareness information is combined with “reminder” advertising or “product claim promotion.” He explained that the proximity of this information “may cause an audience to perceive the two together (i.e. to “link” them), particularly if the two are perceptually similar, thereby making each “promotional.”
FDA views “perceptual similarity” in terms of themes, such as story lines, or other presentation elements, such as colors, logos, tag lines, graphics, distinctive visual elements, common narrator or background music (other elements of “motif”). In addition, other factors for “perceptual similarity” include:
– Close Physical or Temporal Proximity likewise a key criterion; and
– Perceptual distinctiveness in terms of thematic, graphic, visual and other presentation elements is “determinant issue;”
With regards to one product companies, Friede noted that such companies are not automatically disqualified from disease awareness communications, but instead face heightened scrutiny. These entities must consider whether disease awareness information “impliedly” identify a particular drug, and in some cases the presence of the company’s name on the disease awareness piece may, depending on overall meaning and context, be enough for FDA to consider it “promotional.”
Given these examples, Friede explained that FDA has substantial discretion to make judgments on such materials that is difficult to challenge unless a company is willing to risk enforcement action in court and let the court decide the question, but few companies are willing to do that.
To demonstrate the effect of FDA’s discretion regarding these matters, Friede used in his presentation two Novartis-Sponsored Websites for Gleevec®: www.gistalliance.com and www.cmlalliance.com.
In particular, he recognized how in Warning Letters sent to the company, www.gistalliance.com referred to one of the approved indications for Gleevec, i.e. metastatic malignant Gastrointestinal Stromal Tumors [GIST]. He then explained that www.cmlalliance.com referred to one of approved indications for Gleevec, i.e. Philadelphia chromosome positive Chronic Myeloid Leukemia [CML].
Consequently, in FDA applying the concepts from the Draft Disease Awareness Guidance, the agency “concluded that the web sites in fact implicitly “make a representation or suggestion about a specific drug” and thereby effectively promote Gleevec for GIST and CML.” Additionally, FDA found that “a combination of factors collectively amounted to a representation or suggestion about a specific use for Gleevec.”
To Friede, what these cases demonstrated was the difficulty companies are facing as they attempt to provide meaningful disease awareness information to patients and doctors via a web site, without making that communication appear “promotional.” What these examples also represented was how FDA is expanding its jurisdictional reach substantially, even though criteria remain relatively ambiguous.
Friede noted that if FDA is making such changes, how can companies and advertises continue to provide useful information to patients without even a hint of product-specific communication? And even if it’s possible, he wondered whether such communication would even be valuable?
Patients and physicians rely on information from drug advertising to learn about drugs and treatments. Without such information, patients will lose access to data that could impact their health significantly. Restricting this kind of information due to ambiguous regulatory language will harm patients, and make the ethical responsibility of drug companies to convey information burdensome. As a result, FDA must work closely with companies to ensure that this information is not hindered.