Why can't patient-directed information for prescription drugs be promotional?
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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 advertisementBenzo 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).
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I'm going to copy/paste 352 here for reference:
@Jennifer-Carroll said in 352 - Can you please explain the rationale behind not being "promotional" in branded patient-directed material? Product claims would seem to promote adherence, and therefore be beneficial to the patient.:
The PAAB code section you are alluding to is s6. This provision is intended to align with the federal advertising regulations for prescription products which only enable prescription drug advertising directed to HCPs and restricted consumer advertising (the latter being limited to name, price, and quantity). There are no enabling provisions for promotion to patients. Patient information must be consistent with part III of the product monograph (and this "information" is non-promotional). This information can support adherence by educating patients about how to use the product appropriately.
However, the response doesn't quite touch upon my question. C.01.044 only prohibits advertising of prescription drugs to the general public. But patients are not considered part of the general public per the Distinction guidance document.
Is this an oversight by HC, or can promotional advertising to patients really take place?
