DTC INSIGHTS News Alert

November 29, 2007

FDA Plan To Review Broadcast Ads
Moves Ahead with Commitments for 151 Ads

Despite some doubts about the feasibility of FDA 's plan to pre-review broadcast DTC ads,
the program took a major step forward this week. As of the Monday, Nov. 26, deadline, the
agency said it has received commitments from pharma companies to submit 151 television
DTC ads for review during the current federal fiscal year. The agency will have 45 days to
complete these reviews.

A spokeswoman for FDA confirmed that 31 different pharma “entities” had agreed to participate
 in the pre-review program. The number of ads submitted to this new review program at DDMAC
could go beyond the 151 total, but companies will have to pay a penalty for submitting more ads
than they have now committed.

To get the program off the ground this year, FDA apparently needed companies to commit about
 68 ads for pre-review in order to meet the $11 million funding requirement set out in the recently
approved FDA Amendments Act (FDAAA). According to some reports, the agency had received
commitments for just 47 broadcast ads as of mid- November .

The FDAAA legislation outlining the pre-review program had projected that there would be about
 150 pre-reviews in the first year. The next steps are to establish a fee per ad, which will be
publicized via a Federal Register Notice. Payment must be sent to FDA by Jan. 26.

DTC INSIGHT:

The framework for pre-reviewing broadcast DTC ads was established in the FDA Amendments Act
as something of a compromise with the anti-DTC lawmakers who initially favored tighter restrictions.
If this program proves to be a success, it will certainly give legislators who are not opposed to DTC
promotion a stronger foundation on which to maintain their support.