Health Canada (HC) launched a consultation on the 'DRAFT Guidance for Electronic Media in Prescription Drug Labelling' on March 12, 2021 and will close it to new input on May 7, 2021.1 While the title of the document may not openly read ‘advertising’, the proposed guidance mentions many sections of the Food and Drugs Act & Regulations (FDA&R) related to drug advertising and promotion.
This guidance document describes HC’s expectations for distributing information about a prescription drug product using an electronic platform linked to that product’s label, such as websites. Platforms that only contain electronic versions of approved product monographs (PMs) (or package inserts), and do not offer any additional information are not subject to this guidance. However, the design and content of the platform must not violate federal advertising laws. For example, prescription drug information (beyond name, price and quantity), which is accessible to the general public could be considered promotional and in violation of federal advertising laws.
While these platforms are considered an extension of the product label, they cannot be used to replace information that is required by law to appear on a drug’s physical label. The use of electronic media in prescription drug labelling is voluntary and supplementary to existing legal requirements related to label and package requirements, and advertising policy and guidelines.
Companies are permitted to distribute information on their products to consumers and healthcare professionals (HCP) under federal laws and regulations. The challenge is defining what is consideration information and distinguishing it from advertising. HC recognizes the PM as the complete and factual account of a product’s features/ claims/ properties. However, companies often like to offer more than just the PM content by adding features such as expanding on the disease condition, adding health tips and videos on how to take the medication, etc. These outside label activities are permitted; however, they need to comply with federal legislative requirements under the FDA&R and align with the limitations of the approved PM.
Federal advertising laws apply to electronic platforms linked to a prescription drug label
- The FDA defines an advertisement as “any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.” Drug advertising is subject to the following key provisions:
- The promotion of a drug is limited to authorized drugs (C.08.002(1) of the FDR)
- A drug may not be advertised in a manner that is false, misleading or deceptive (Section 9 of the FDA)
- The promotion of a prescription drug to the general public is limited to name, price and quantity (C.01.044 of the FDR)
- A drug may not be advertised to the general public for the treatment, prevention or cure for any Schedule A disease, disorder of abnormal physical state (Section 3 of the FDA)
- Controlled drugs, narcotics and targeted substances may not be advertised to the general public (Section G.01.007 of the FDR)
This HC guidance now clearly dictates the need for a gating mechanism for electronic platforms such as branded websites accessible to the general public. This requirement was never clearly stated in HC policies and reference to section C.01.044 of the FDR has formerly been used as the reason to comply. The new draft guidance states: “When designing a platform intended for patients or health care providers, you should incorporate a robust ‘gating’ mechanism (a virtual barrier that requires user authentication) on the platform to prevent public access. A “no-index” meta tag should also be used for every page behind a gating mechanism to prevent public access through search engine results.” This guidance does not define what would be acceptable as a ‘robust gating’ mechanism and suggests that sponsors take appropriate measures to prevent potential compliance issues.
This new draft guidance not only addresses package inner/outer labelling requirements but also addresses links to external electronic platforms that may be considered advertising; subject to advertising laws, regulations and policies.
Reference:
(1) Consultation: Electronic media in prescription drug labelling draft guidance document https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/electronic-media-prescription-drug-labelling.html
Author:
John Wong, Director, Scientific Affairs & Medical Information, TPIreg/Innomar Strategies Inc.