On Monday, the US Food and Drug Administration (“FDA”) made available a new draft guidance, entitled “Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.”The draft guidance is the latest version in a series of guidance documents that FDA has issued on the topic.

In 1999, FDA published draft guidance with the same title, which was finalized last year in January 2012. The 2012 final guidance addressed the requirements for product name, placement, size, prominence and frequency in promotional labeling and advertising for prescription human and animal drugs and biological products.Now, the agency has “recognized the need for additional clarification and explanation of how FDA would exercise its enforcement discretion.”3

The new draft guidance, which is intended to replace the 2012 guidance, clarifies the regulatory requirements and articulates the circumstances under which FDA intends to exercise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. Among other things, the new draft guidance updates the previous final guidance by stating that FDA intends to exercise enforcement discretion with regard to:

  • Presentation of the established name with the proprietary name “at least once per page or spread where the proprietary name most prominently appears on the page or spread,” instead of each time the proprietary name is featured; and
  • Audiovisual promotional labeling and advertising in which an established name is not included in the audio portion (contrary to a previous recommendation in the 2012 guidance).

FDA’s continued focus on this issue suggests that it is one of importance for the agency. However, in the last 15 years, it appears that 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.

Comments on the new guidance should be submitted to the FDA within the next 60 days.