ASC Circular 2018-003 – Rendition of GENERIC NAMES per AO 2016-008 (Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use)

The Center for Drug Regulation and Research (CDRR) of the Food and Drug Administration (FDA) has called the attention of the Ad Standards Council (ASC) on the proper rendition of the GENERIC NAME given the various forms of media.

In connection with this, please find below basic guidelines by medium per AO 2016-0008 – Revised Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use, subject to the following requirements.

I. For advertisements on Television, Cinema, Electronic Billboard, and Digital Videos

A. For materials 30 seconds and longer

  1. All TV, Cinema, Electronic Billboards and Digital Videos shall prominently show the GENERIC NAME inside a box, together with the Brand Name (if any) during the first brand mention and towards the end of the material. For the second time the GENERIC NAME inside a box is shown, it shall be featured for at least one (1) second.
  2. If the GENERIC NAME inside a box being shown is on the product shot and is not reasonably readable, the GENERIC NAME inside a box shall be prominently shown separate of the product shot but within the same frame.
  3. The GENERIC NAME shall appear prominently larger than the Brand Name (if any), with prominence being clearly and distinctly readable by normal vision as may be determined by common visual sense. Moreover, the GENERIC NAME should also be prominent over the other information on the same frame where the GENERIC NAME and Brand Name appear.

FDA

B. For materials 29 seconds and shorter

  1. All TV, Cinema, Electronic Billboards and Digital Videos shall prominently show the GENERIC NAME inside a box together with the Brand Name (if any) at least once within the material for at least one (1) second.
  2. If the GENERIC NAME inside a box is on the product shot and is not reasonably readable, the GENERIC NAME inside a box shall be prominently shown at least once separate of the product shot but within the same frame.
  3. The GENERIC NAME shall appear prominently larger than the Brand Name (if any), with prominence being clearly and distinctly readable by normal vision as may be determined by common visual sense. Moreover, the GENERIC NAME should also be prominent over the other information on the same frame where the GENERIC NAME and Brand Name appear.

FDA

C. Advertisements showing two (2) or more products shall follow the same rules as stated above.

II. For advertisements on Radio

Advertisements on Radio whether recorded or live without reference to material length

1. All Radio advertisements shall mention towards the end the following line: “GENERIC NAME is the generic name of BRAND NAME”.

2. Rendition of the generic name line should be reasonably audible.

III. For Advertisements on Print, OOH, collaterals and Static Digital Posts

1. The GENERIC NAME shall appear prominently larger than the Brand Name (if any), with prominence being clearly and distinctly readable by normal vision as may be determined by common visual sense. Moreover, the GENERIC NAME should also be prominent over the other information on the same frame/lay-out where the GENERIC NAME and Brand Name appear

FDA

The aforementioned guidelines will be in effect for new applications starting April 2, 2018.

OTC/HR materials approved before April 2, 2018 will be honored by ASC until their validity dates.

However, if previously-approved OTC/HR materials will be renewed, these will have to comply with the guidelines per AO 2016-0008 as discussed above.

For strict compliance.

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