Friday, June 03, 2005

BIG NEWS: Congress Proposes DTC Changes

Congress Proposes DTC Changes


Under new drug safety legislation proposed by Senators Grassley (R-Iowa), and Dodd (D-Connecticut) DTC would have some new requirements. A significant change would be pre-clearance of promotional material. Of course, that is not a change for most drug companies that pre-clear ads now.


The issue with formal pre-clearance is that DDMAC may take longer and be more conservative in approving ads. Currently, DDMAC can say it is a non-binding opinion and change their mind later. Under a system of formal pre-clearance they no longer have this luxury. The other issue is staffing to ensure all ads get pre-cleared on a timely basis so drug companies can commit to media buys.


The Grassley-Dodd bill also requires new drugs in the first two years to disclose several key facts. Ads and other promo material must prominently disclose in understandable language the following: the drug is new and therefore all side effects are not known, the number of people studied in clinical trials, a statement encouraging consumers to discuss risks with their doctor, any clinical studies still to be done and their purpose, and contact information to report adverse events.


The above requirement could be a handful to report in a television ad. I would expect at least another 10-15 seconds would be needed to incorporate the above information. If this bill passes, then branded television may be a challenge for new drugs. This may make print/web/direct mail the media of choice. Television could be used for non-branded help seeking ads for the condition. For first-in-class drugs, where unknowns exist, I would expect branded television to be problematic. For me-too drugs, branded television is still doable because it is unlikely new clinicals are being done to establish safety.


What is certain is that drug companies need to be very flexible about how they plan their DTC. They need to be ready to use alternatives to branded television if this bill or other FDA guidances make branded television difficult. Every drug company is probably working their DTC departments overtime on scenario planning for different levels of restrictions. Media companies better be very savvy about these potential changes when they pitch potential clients because each provision has media implications.

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