The 60-Second Guide to Understanding DDMAC’s

Guidance on Prelaunch Communications

By Geoff Sheldon, VP Brand Planning Director

The DDMAC guidance pertaining to prelaunch

communications is very clear

• Preapproval promotion is not allowed, except in the following forms

1. Institutional promotional materials, which state that a named drug

company is conducting research in a certain therapeutic area to

develop new and important drugs

• This type of promotional material may not mention any drug name, either

proprietary or established

2. “Coming soon” promotional materials, which announce the name of a

new product that will soon become available

• “Coming soon” advertisements may not make written, verbal or graphic

representations or suggestions concerning the safety, efficacy, or

intended use of the product

Both allowable forms have their advantages and

disadvantages

“Coming Soon” Promotions “Institutional” Promotions

ProsConsidered the best way to create prelaunch buzz

and brand name awareness when there is already

a great deal of knowledge that the product is in

development

ProsConsidered the best way to generate increased

interest in a specific therapeutic category or

disease state area

ConsThere is no ability to make any potential claims

pertaining to indication/dosing/effectiveness or

safety (only the words “coming soon” and the

brands name and logo can appear in the

communications)

ConsCan only talk about the fact that a company is

conducting research and development in a certain

therapeutic area without mentioning what the

research is specifically for (no reference to any

brand/generic names or potential marketing claims

can be made)

Once you decide which direction to follow, you must stick

with it

Companies can use either institutional or “coming soon”

promotion during the preapproval stage but are not allowed to

change back and forth between the two types.

Unfortunately the options are limited if a brand has, or is

likely to have a boxed warning

Companies cannot use “coming soon” promotions in the

preapproval stage if a prescription drug is known to have or is

likely to have a boxed warning, because “coming soon” promotion

is considered reminder promotion, which usually is not allowed

for approved products with boxed warnings.

In short…

• To stay compliant with the guidance issued by DDMAC associated

with prelaunch promotional materials for pharmaceutical brands

– You are limited to developing either “coming soon” or “institutional” promotional

materials

– You have to pursue one direction, as you are not allowed to switch between

“coming soon” and institutional in the prelaunch period

– If you have, or are likely to have, a boxed warning in your label you are not able to

develop “coming soon” promotional materials, and are therefore limited to the

“institutional” approach