With respect to BRANDED DTC advertising for Rx drugs we note that on the opinion response there is an expiry date provided with the eFile number as with typical promo materials.
These opinions should not expire as no change in the marketplace would influence a change in the opinion. DTCA is restricted to price, name, and quantity and thus a new drug on the market or a change to the PM would not have any bearing. Consistent with that is that ASC doesn’t tie an expiry date to their opinion.
This may be very different for DTCI where a company may have a piece that includes all available treatment options. This certainly could change over time.
The expiry date is even more confusing because the Food & Drug act doesn’t mandate a company to submit pieces for an opinion but only that they comply with the DTC Rules and Regs.
What is the role of the date on the response? Is it really an expiry date? And if so, why is there an expiry date?