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by Mark S. Senak
Eye On FDA



There have been several proposals before Congress which, in one way or another, have the potential to impact the amount of direct-to-consumer advertising (DTC) allowed. Some would give the FDA authority to restrict such advertising. Others have called for it to be abandoned for any new product's first few years on the market. What is the impact on new drug launches in the face of success of any such proposal?

Prior to the existence of DTC, public relations played an essential role in the launch of new medications and in the uptake of new medications, and it still does. But in the event of a ban or partial ban, the role of public relations to strategically inform the public - patients and prescribers - about the role of a new treatment obviously becomes more important. Innovators go through a great deal of money on funding research and development that is recouped when a drug comes to market - an uptake is an essential part of the formula. Therefore, it is incumbent on public relations companies to determine how such a ban would affect their communications strategies now, not later.

But it also raises another important point. There have also been proposals to raise the amount of money for review of DTC by FDA, despite the fact that the oversight by DDMAC as expressed through warning letters has shrunk to anemic levels in the past several years. If a part of DTC disappears, does FDA still need more money for DTC oversight? One would think with less enforcement over the past several years, and fewer potential ads, the money equation would flow the other way.


Source: EyeOnFDA.com


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