Hereâ€™s Senator Kennedyâ€™s perspective:
"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA â€¦ wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.â€
But FDA already negotiates such circumstances. Thatâ€™s the key word, â€œnegotiate.â€ And itâ€™s not a finesse. Minus that word itâ€™s â€¦ unconstitutional.
And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.
Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."
Drugwonks does not believe that less information makes anything or anyone safter.
Make no mistake â€“ this is a battle not only over the future role of the empowered health care consumer â€“ but for the First Amendment.
Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.
But itâ€™s not a question of the time â€“ itâ€™s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But itâ€™s not necessarily a question of â€œmoreâ€ as much as it is a question of â€œbetter.â€ And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.
Sounds like a good opening assignment for the agencyâ€™s new advisory committee on risk communications.
If we truly want to create a situation where our medicines are â€œsaferâ€ we must learn how to better communicate risk and benefit â€“ not limit it.
Otherwise the empowered health care consumer might very well be gone in 60 seconds.