1. PAAB’s Accelerated Review Options
In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of urgency levels and budgets. As it will be a pilot launch, the AROs will initially only be for certain submission types.
With Advertising / Promotion Systems (APS) submitted through the standard pathway, PAAB provides the first response within 10 business days and responses for revisions within 3 days. APS submitted through the new ARO pathways (except ARO-10) will receive the initial response faster (2, 4 or 7 days for ARO-2, ARO-4 and ARO-7, respectively). ARO-10 submissions will receive the initial response within the same timeframe as the standard pathway (10 days) but will benefit from the other ARO advantages, including responses for revisions within 2 days.
The fee charged will vary depending on the pathway. For example, with most APS (e.g. excluding “minor updates”), the base fee for reviewing one APS in one language increases from $390 for the standard pathway to $1170 for the ARO-2 pathway (i.e. initial review in 2 days instead of 10).
In addition to speed, another key benefit of ARO is being able to use the “messenger functionality” to obtain timely review decisions (within 24 hours) from PAAB on pivotal segments of the APS. This means feedback on key sections can be obtained without having to resubmit the entire revised copydeck / layout. This advantage should improve both efficiency and speed in achieving final PAAB approval.
PAAB will be assessing the pilot carefully and will adjust details, including submission eligibility, fees and message limits, accordingly.
See PAAB’s Complementing the Standard Preclearance Pathway with Accelerated Review Options (AROs) - Planned Features Document (January 2022, updated from November 2021 version) for full ARO details, as well as other PAAB updates, including the introduction of fees for modular submissions (e.g. module library) and iterative submissions (e.g. APS contains variable fields or the email subject line varies depending on audience demographics).
2. Meta’s restriction on targeted advertising for health-related topics
On January 19, 2022, Meta Platforms, Inc (Meta) implemented changes to make it more difficult for advertisers using any of its platforms (including Facebook and Instagram) to use targeted advertising for certain sensitive topics. Meta’s detailed targeting options can no longer be used to reference causes, organizations or public figures relating to health, including health causes like “Lung Cancer Awareness”, “World Diabetes Day” and “Chemotherapy”, thereby reducing the potential for its platforms to be abused.
Canada already has numerous regulatory laws which limit how health products and services can be advertised, including restrictions on direct-to-consumer advertising of prescription drugs. In addition, Canada’s privacy laws already prohibit online behavioural advertising for sensitive information such as personal health information, without express, opt-in consent (see Office of the Privacy Commissioner of Canada’s “Use of sensitive health information for targeting of Google ads raises privacy concerns” and “Tracking and ads”). Whether communicating for purposes of clinical trial recruitment, disease awareness or otherwise, the recent Meta development is another factor that advertisers in the life sciences and health industries must navigate.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Related Publications & Articles
A proposed program by the state of Florida to import certain prescription drugs from Canada has received the approval of the United States Food and Drug Administration (FDA): FDA news release on Janua...Read More
On January 3, 2024, Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) came into force.Read More
Health Canada provides clarifications on application of the definition of Canadian reference product based on Dormant statusOn January 26, 2024, Health Canada published a notice confirming the Department will apply the definition of CRP consistent with its proposal.Read More