Infographic: Volume of FDA filings increased as DTC-price rule was set to take effect

The back-and-forth over the Department of Health and Human Services rule requiring inclusion of list prices in TV drug ads had advertisers scrambling to file Form 2253 submissions to the FDA.

MM+M Staff

August 2, 2019

9:46 am

As advertisers scrambled to comply with the Department of Health and Human Services rule requiring inclusion of list prices in TV drug ads (see timeline), the number of Form 2253 submissions advertisers filed with the FDA increased (see bar chart). Any firm revising its DTC spots, whether to include or remove pricing language, needs to submit the language under a Form 2253. Asked to further qualify the filings, the agency said that filings for consumer-directed promotional pieces rose to 3,301 in June vs. 3,114 the same month last year, and to 1,494 in first-half July vs. 1,359 for that same year-ago period.

Click on the text in the timeline below for more about DTC ads and drug pricing.

Number of Form 2253 submissions filed with the FDA

This article was updated to characterize the change in the volume of 2253 filings as an “increase” rather than a “spike,” as well as to add the context around the nature of the filings for June and first-half July.

From the August 01, 2019 Issue of MM+M - Medical Marketing and Media