What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane.
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane.
