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QnC

@QnC
Agency
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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Recent Best Controversial

  • Why can't patient-directed information for prescription drugs be promotional?
    Q QnC

    Given the following regulations and definitions, why can't patient-directed APS for prescription/controlled/targeted drugs be promotional?

    FDA Section 3(1): No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

    FDR Section A.01.067: A drug is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

    FDR Section C.01.044: If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug.

    CDSA Section G.01.007: No person shall
    a. advertise a controlled drug to the general public or
    b. issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement

    Benzo Regs Section 78: A person must not:
    a. advertise a targeted substance to the general public or
    b. issue or publish an advertisement for a targeted substance unless the advertisement:
    i. is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals and
    ii. displays in the upper left quarter of its first page, in a clear manner and in a conspicuous colour and size, the following symbol:

    And definitions from Guidance on distinction between advertising and other activities for health products:

    Patient: An individual who has a medical condition and is receiving, or is registered to receive, care.

    General public: Ordinary people, especially all the people who are not members of a particular medical, pharmaceutical or scientific organization or who do not have any special type of medical or scientific knowledge. This excludes persons who have been prescribed a health product by a health care professional (HCP).

    Patient Info
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