Expiry Date on PAAB Opinion response
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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?
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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?
Hi @sonalip9
It’s an interesting question and at face value might seem rational to think an expiry is illogical. However, the regulatory landscape for pharmaceutical advertising direct-to-consumers is more complex than “name, price, quantity”. There are linkages to consider, the totality of marketing campaigns which change over time as well as continuously updated rulings from Health Canada on what is deemed to align with federal regulations. It may not be possible for companies to be aware of all review rulings and understand if they impact their DTCA campaigns. The expiry date encourages companies to stay proactive about regulatory compliance and reassessment to occur in the context of the current market and regulatory environment, not the market of 1, 2 or 3 years past.
If the concern is the cost and effort associated with maintaining a file’s acceptance status, we encourage you to utilize the new Renewals Management Dashboard. It was designed to help streamline your renewal submissions and track upcoming renewals. When a renewal is submitted 6 weeks or more in advance of the prior eFile’s expiry, it may be eligible for the early renewal discount, which is 50% off the associated full fee. Rest assured, if you renew early your new acceptance period for the new file will not begin until the end of the prior file’s acceptance period. You can learn more about the Renewals Management Dashboard here.
