The number of broadcast direct-to-consumer ads disseminated by the pharmaceutical industry dropped by 24% in 2005, according to FDA.

The agency reviewed 337 final broadcast ads in 2005, down from 441 in 2004, according to Division of Drug Marketing & Advertising DTC Review Group Leader Melissa Moncavage.

Data presented by the FDAer during the DTC National conference in Washington, D.C. April 27 showed an increasing trend in the number of disseminated broadcast ads, peaking in 2004, with 441 disseminated ads ( ¹ see chart ).

In contrast, the number of ads submitted for FDA review prior to dissemination saw an overall decrease between 2000 (with 201 proposed ads submitted) and 2004 (142 proposed ads submitted). The number of proposed ads reviewed by FDA in 2005 - 146 - remained relatively flat compared to 2004.

Companies are not required to submit proposed ads to FDA for review, although they must submit a copy of all promotional pieces at the time of first public use.

However, pre-broadcast review figures are likely to increase: the Pharmaceutical Research & Manufacturers of America's DTC "guiding principles" call for companies to have all broadcast ads reviewed by FDA prior to being aired (² Also see "PhRMA DTC Principles Compliance To Get Independent Panel Review In 2007" - Pink Sheet, 8 August, 2005., p. 8).

The percentage increase in consumer promotional pieces submitted to FDA in 2005 grew more than the percentage increase in the total number of promotional pieces submitted.

FDA received 9,285 consumer promotional pieces in 2005 compared to 8,417 in 2004, a 10% increase. The total number of pieces submitted (including consumer, professional and mixed promotions) grew only 3.4%, from 52,848 in 2004 to 54,661 in 2005 ( ³ see chart ).

The "mixed" category refers to internet-based promotions, Moncavage noted. "Usually websites come in and it contains something for everybody," she said.

Mixed promotions were down slightly in 2005 - from 6,908 to 6,228 - but "in general the trend is going up for World Wide Web submissions."

There was also a significant increase in promotions reviewed by DDMAC between 2003 and 2004 because of the transfer of some products from the biologic center to the drug center at FDA.

The agency's figures on the types of drugs advertised on radio or television show skin and hair related products are advertised the most, with 15 different drugs or indications promoted since 1997.

The next most-advertised therapeutic categories are allergy (14 drugs or indications), cholesterol/heart disease (12), and mental health (11).

Moncavage noted that "generally the trend is for the products that are being advertised to be really more complicated products with kind of nuanced indications, serious risk information."

"When these more complicated products come to us it might take us a little longer to try to understand how to make sure that the most important information does get included in the TV ad," she said.

Broadcast Drug Ads Down In 2005 While Overall Consumer Promotions Rise

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