In the new draft of “Guidance for Industry – Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling” FDA addresses usage of prescription
drugs proprietary names in promotional materials and labeling.
The guidance that is intended to replace its previous version from January 2012 describes requirements for product name placement, size, prominence, and frequency in promotional labelling and advertising for prescription drugs. It also clarifies the regulatory requirements and articulates the circumstances under which FDA intends to exercise enforcement discretion for the use of proprietary and established names in promotional labeling and advertising. The new guidance:
- Clarifies issues about intervening matter in relation to the juxtaposition of the proprietary and established name;
- States that FDA intends to exercise enforcement discretion regarding the requirements surrounding the use of the established name on pages or spreads and offers an example of what is expected;
- Clarifies the requirements regarding the use of proprietary names in the running text;
- States that FDA intends to exercise enforcement discretion regarding the established name’s presentation in columns;
- Removes the recommendation that the established name be included in the audio portion of an audiovisual promotion; and
- Clarifies issues relating to the established name’s presentation on Web pages or electronic screens.
The new FDA policy is that:
- Firms should include the established name at least once per page or spread where the proprietary name most prominently appears.
- The established name should be placed either directly beside or below the proprietary name without any intervening matter.
- The size of the established name should be at least half the size of the presentation of the proprietary name wherever the established name is required.
- For superimposed text that is equivalent to a headline or tagline, the established name should be presented alongside the most prominent presentation of the proprietary name in audiovisual promotional materials.
- For electronic and computer-based promotion, the established name should accompany the proprietary name at least once per Web page or screen, and this should generally be where the proprietary name most prominently appears on the Web page or screen.
Industry can submit comments on the draft to the FDA before January 21, 2014. According to the FDA there are 400 companies that will be affected by the change.
While the update of the guidelines may suggest high importance of the topic, the data says otherwise. In the last 15 years, according to the law firm Hunton & Williams LLP, FDA has sent fewer than 20 warning and untitled letters for human drug and biologic products in which the presentation of a product’s established name was considered violative. In almost all of these cases, the inadequate presentation of an established name was one of the last violations discussed in the letters, signaling its relatively low degree of importance compared to other issues, such as overstatement of efficacy and minimization of risk.