Attention To Detail: The FDA Is Watching You

By Ian DeMeritt, PhD (@idemeritt)

As printed promotional materials are continually being replaced by flashier electronic detail aids and on-line content, it is not surprising that DDMAC continues to cast a regulatory eye on digital presentations of pharmaceutical advertisements. Last April, they fired a resounding shot across the bow of the pharma world that sent a clear message: DDMAC is well aware of the goings-on in the digital realm and it will enforce online media as diligently as that in print form. The more recent FDA hearings on social media, the FDAs new “transparency blog, and the recently-launched “FDA basics Web site demonstrate a growing commitment to their online presence.

The watchful online eye of the FDA was again demonstrated late this week when DDMAC warned 2 pharmaceutical Web sites for making false and misleading claims. While these new letters do not contain any new or groundbreaking information regarding DDMACs interpretation of the advertising laws as they apply to Web-based content, they do serve as a useful reminder of some pitfalls to avoid when designing Web sites for a pharmaceutical product. In addition to the familiar “Unsubstantiated Claims castigations, warnings related to speciously presented risk information were a key component of each letter.

Both products cited (Isovue and Visipaque) are intravascularly administered contrast media indicated for imaging of the cardiovascular system. Both product labels contain boxed and bolded warnings cautioning against a laundry list of severe and frightening risks including death, convulsions, cerebral hemorrhage, coma, paralysis, and brain edema, among others.

Despite these warnings, the GE Healthcare Web site describing Visipaque boasted an “excellent safety profile and declared that it was “designed for patient safety and comfort. The only risks listed on the Visapaque Web site were general cautions against blood clotting, thromboembolic events, and use in certain patients. And while the Isovue Website (which presents the results of a head-to-head clinical study against Visipaque) did mention the possibility of severe reactions, the potential for fatal adverse events was not disclosed. This stark omission of important risk information did not escape the notice of DDMAC reviewers and these letters serve as a reminder that all relevant risk information, regardless of the implications to the brand, must be presented to balance promotional claims.

Furthermore, DDMACs letters reiterate that the placement and presentation of risk information is just as important in electronic format as it is in a printed piece. The Visipaque risk information was located at the very bottom of a long page of text, hidden below the references. Despite headlines heralding “Product Highlights and “Product Description, the risk information was not marked in any way to indicate to the reader that it was either present or important. Similarly, the risk information on the Isovue Web site was portrayed in a smaller font size than the promotional copy and without any headers to indicate its importance or presence.

It should be noted that both Web sites contained a link to the full prescribing information. However, as previous Warning letters have demonstrated, DDMAC is no fan of the so-called “one-click rule.

While these new letters reveal no momentous changes in DDMAC policy concerning Web-based content, they do reinforce several lessons to keep in mind when creating, designing, reviewing, or reading pharmaceutical-based Web content:

Lesson 1. Safety Information must be clearly labeled as such and be given prominent placement on a Web page

Lesson 2. Risk information must be presented in a similar font size and appearance as promotional messages

Lesson 3. The FDA does not consider any pharmaceutical product with a boxed or bolded warning to be “safe and any promotional messages to this effect are at risk

Lesson 4. All relevant risk information must be presented, regardless of how scary it might sound or the potential implications for the brand

Lesson 5. A “Please see¢‚Ǩ¬¶ line and/or a link to the PI is not sufficient to replace missing risk information.

Lesson 6. The “one-click rule is still dead.