August 15, 2011
Google Plus would enable Pharma to disable comments
One of the features that Google Plus offers is the ability to limit and maintain a message within 'circles', which are pre-selected members by the administrator of the Google Plus account. I was very excited about this the day that Google Plus launched, but I had not played with the site long enough to really be sure that it would be possible to contain a message within the circle. Here is a link to my original blog post on the topic. Since that day, I can now confirm that this could indeed work for the pharma industry, even in Canada (and other countries with restrictive regulations). Here are the steps:
- Pharma company sets up a business page (once these are allowed by Google Plus)
- Members who wish to receive messages from the pharmaceutical company must prove somehow that they have a prescription for the product. They can do this by providing the DIN or other information that is acceptable within regulations.
- Only those members with proof of prescription are then added to a pre-defined circle. Be careful not to have too many circles, as it could be easy for an administrator to make an error and send the message to the incorrect circle (and we all know this would result in a regulatory 'no-no')
- Pharma company writes post and clicks on 'share'. Make sure only the appropriate circle is included, and avoid at all cost using the 'public' share button.
- Once the post has been shared, click on the arrow button on the top right corner of the post. This will bring down a drop-menu which allows you to select 'disable comments' and / or 'disable reshare'.
In Canada, pharmaceutical companies must follow very restrictive Rx-DTC (direct-to-consumer) guidelines. The only things that can be mentioned in the public regarding Schedule F Rx products are product name, price and quantity. Not very exciting for consumers, patients, healthcare professionals, or any other stakeholder. However, Canadian pharmaceutical companies are allowed to provide product information to patients who have received a prescription from a healthcare professional for their product. This is referred to as direct-to-patient (DTP) marketing. Unfortunately, it is nearly impossible to develop a gated social site which only includes members who have a prescription for a particular drug, on a mainstream social media site. That is until Google Plus showed up. Of course, there are companies that specialize in customized gated sites, but in this blog post, I am referring to the popular social sites which are already frequented by the general public.
Here is what Ray Chepesiuk, Commissioner (CEO) of PAAB (Pharmaceutical Advertising Advisory Board - Canada), had to say about Google Plus and the pharma industry:
"This is a good example of what I was talking about years ago. The regulations still apply, it is the media that does not fit eg Facebook and Twitter for Canadian Pharma. In Google+ we have an example where the media has changed in a direction that is more amenable to Canadian Pharma communicating through social media to patients and doctors about brand information that is directly related to the product monograph. It will be interesting to see if doctors and patients want to communicate directly within a pharma sponsored site. It does make the creativity box bigger. It will also be useful for internal communications and also with KOLs and other external suppliers. Hopefully pharma will get to understand the utility of these media tools and get good advice on how to adapt them within the regulatory framework. The PAAB can help you do that through the preclearance review program."
Now we just have to wait for Google Plus to allow businesses to set up pages (impatient finger tapping by me and many others).
In the meantime, if you have not tried Google Plus yet, I urge you to do so. Once Google Plus does announce that businesses are allowed on its network, you don't want to be scrambling to start figuring out the network. If it's an invitation that you are waiting for, here is one from me. Just click this Google Plus invitation link and enjoy!
This is a particularly important topic today because FaceBook is no longer supporting pharmaceutical companies who want to disable comments from their FaceBook page walls. You can read more about it here. Some pharmaceutical companies are responding by simply removing their FaceBook pages. You can keep track of which pharmaceutical FaceBook pages are staying up, and which are being removed in the Dose of Digital blog.
Do you think pharma companies who have removed their FaceBook page, or who would like to use a similar type of networking format, would consider Google Plus as an option (of course, only once Google Plus allows business profiles on its network)? Please let me know if the comments below.
June 30, 2011
Congrats MS Village Canada (FaceBook) and MSWatch Canada – 2011 DOSIE winners
The Dose of Digital site has announced the 2011 DOSIE winners, and 2 of the wins were by Canadian pharma organizations: MS Village FaceBook page has won Silver for the Judges' award, and MSWatch.ca has won the People's Choice award.
I am very pleased to see MSWatch.ca win the People's Choice award because they worked very hard over the past year to completely revamp their site in order for it to meet Canadian regulatory guidelines. To learn more about their evolution, check out this post which explains what they did when they closed their original site, and this post which details the revisions made to the site.
The MS Village FaceBook page won the DOSIE award, but their social offerings are much greater than just that. Check out the main MS Village site to learn more about them. I have also often seen MS Village advertised in FaceBook ads.
Congratulations to both! What a great way to kick off the Canada Day long weekend.
May 3, 2011
Canadian Pharma Rx-DTC getting even more restrictive? Maybe!
If you had a voice on the future of pharmaceutical Rx direct-to-consumer (Rx-DTC) advertising in Canada, what would you recommend?
On January 21 2011, Health Canada held a meeting called "Technical Discussions on Regulatory Modernization". This meeting had several regulatory-related topics on the agenda, but there was one topic that should be on the minds of all Canadian pharmaceutial stakeholders:
"The objective of the model proposed in this document is to ensure that advertising is accurate, fair, evidence-based, and consistent with the information contained in the market authorization for the product. Advertising should neither exaggerate potential benefits nor minimize possible risks, but support health care professionals and consumers in making informed choices about the therapeutic products that they use. In addition, it should be clear to the intended recipient that an advertisement is indeed an advertisement, and those who provide such representations should be transparent in their activities.
You can find the "Mock Framework for Discussion" (proposed model) below, verbatim from the document that Health Canada provided to the attendees of the meeting. Keep in mind that it is a draft, and amendments are likely to occur. Therefore this should not be considered the final copy whatsoever. But nonetheless, it does give you an indication of the direction in which Health Canada would like to move. A summary document of the technical discussions is supposed to be published on the Health Canada website, but this will probably take weeks if not months because there are other technical discussion meetings that took place prior to the promotional discussion which need to be posted before-hand, and they still have not been posted either.
Notice that there is no mention of an Rx-DTC clause in the document below. Does this mean that our current restrictive Schedule F Rx-DTC guidelines that only allow us as an industry to talk about drug name, price, quantity might be removed? It is a possibility.
So back to the original objective stated: "support health care professionals and consumers in making informed choices about the therapeutic products that they use". Yeah, right (enter sarcasm detector here)! Canadian patients and the general public will have to continue to rely on the data that they find sourced from other nations. A step forward? I personally don't think so, but then again, that's just the opinion of one person. I am curious to hear what others think, those from the pharma industry (client and agency), patients, healthcare professionals and others.
If you were able to vote on this document, would you :
a) accept the removal of the clause (thus not allowing any kind of Rx-DTC which mention a drug name in Canada), or
b) fight to put it back in as it currently exists
c) fight to put it back in and amend it so that it is less restrictive (and what part would you make less restrictive - be specific if you can)
If you do comment, it would be helpful to know what your relationship is with the pharmaceutical industry, and whether your experience is Canadian or other.
_______________________________________________
Mock Framework for Discussion
1. Definitions
- “advertise” means any representation by any means whatever for the purpose of promoting directly or indirectly the sale or use of a drug or medical device.
- “claim” means any representation made on behalf of a health product, including the indication for use.
2. Drugs
Prescription and Nonprescription
- No person shall advertise a drug that does not have a market authorization.
- No person shall advertise a drug in a manner that directly or indirectly represents that the drug:
o is not a drug,
o is a food, or
o is a cosmetic.
- No person shall advertise a drug for which the market authorization is suspended or revoked, or for which a particular indication (use) has been suspended or revoked.
- No person shall advertise a drug for an indication (use) that is not included in the market authorization for that drug.
- Advertising of drugs that have a market authorization with special conditions shall indicate the special conditions of authorization in the advertisement.
- Any advertisement shall be set out in such a way that it is clear that the message is an advertisement.
- Persons who receive compensation of any kind from a market authorization holder to promote, either directly or indirectly, a drug or device must declare such an affiliation.
- The advertising of a drug shall not exaggerate its benefits or minimize its risks, but provide factual information so that practitioners or consumers can make an appropriate and informed choice.
- Advertisements for drugs shall be consistent with the market authorization for the drug and its approved labelling, including:
o Indications (intended uses)
o Medicinal and non-medicinal ingredients
o Potential benefits, including efficacy
o Directions for use
o Dosage
o Administration
o Onset and duration of action
o Duration of use
o Potential harms, including adverse events.
- Any advertising claims, both direct and indirect, must be consistent with the market authorization, its special conditions (if any), and be supported by the scientific evidence submitted with the application for market authorization. This includes, but is not limited to, claims regarding:
o therapeutic comparisons with other products
o results of clinical tests
o reduction of risks and adverse events
o potency.
- Visual representations and graphics included in advertisements shall not directly or indirectly represent indications (uses) or potential benefits for which the drug has no market authorization.
- Advertisements for drugs shall not be directed at children.
- Misleading advertising
o Advertisements are considered to be misleading if they:
§ represent a guarantee of benefit or an absence of any risk (e.g. statement of being “safe”)
§ represent that a drug:
- has ingredients that it does not have, or
- does not have ingredients that it does have
§ represent that the drug’s actions are due to the fact that it is natural
§ represent that the health of the user can be enhanced by the use of the drug.
- Where Health Canada is of the opinion that advertising is in violation of the regulations, it may issue a notice of direction to the market authorization holder instructing it to:
o cease such advertising immediately, or
o revise such advertising to bring it into compliance with the regulations.
- Such a notice of direction shall be issued in writing and include the following:
o Name of the drug
o Advertisement in question
o Reason(s) for the notice
o Date on which the advertising in question must cease, or be modified
o Instructions concerning requests for representations
o Date by which such a request must be made
o Contact name and information.
- The market authorization holder may request, in writing, the opportunity to make representations to Health Canada considering the notice of direction, by the date indicated in the notice of direction.
- After hearing representations, Health Canada will provide in writing to the market authorization holder confirmation if the notice of direction remains or an instruction regarding acceptable modifications to the advertising in question.
- Health Canada may suspend the market authorization of a drug if a market authorization holder is not in compliance with regulations regarding advertising or is not in compliance with a notice of direction.
Nonprescription drugs
- An advertisement for the general public shall contain the following minimum information:
o Name of the drug
o Information needed for the correct use of the drug, including potential risks
o Legible instruction to read the information on the outer or inner label, as appropriate.
Prescription Drugs
- Any advertisement of a prescription drug to a practitioner must include the essential information regarding the drug’s:
o Indications
o Dosage and dosage form
o Route of administration
o Frequency of administration
o Storage and preparation instructions
o Contraindications
o Warnings and precautions
o Adverse events.
- Any inclusion of material from medical or scientific journals in documentation provided to practitioners must include the date, be faithful reproductions, and indicate the source.
- Sales representatives shall provide to practitioners with each visit, or have available for them, current authorized product monographs or prescribing information.
Vaccines
- A person may advertise a vaccine to the general public if Health Canada is of the opinion that such advertising is in the interest of public health.
- Any advertising of a vaccine to the general public must meet the requirements of the regulations for advertising and include the following information:
- Name of the drug
- Indication(s)
- Information regarding the vaccine’s potential benefits and risks.
3. Medical Devices
Currently, there is no requirement for preclearance of advertising for medical devices in Canada. However, medical devices are subject to the provisions of the Food and Drugs Act (specifically Sections 3 and 19 – 21) and the Medical Devices Regulations (MDRs), as they pertain to advertising. No person shall advertise a device that does not have a market authorization.
Section 27 of the MDRs restricts the advertising of class II, III and IV devices to those devices which have licences. However, there is a provision for advertising of unlicensed devices in catalogues if a suitable disclaimer is present. The advertising of devices for investigational testing is restricted under section 87 which requires that the device be authorized and that the advertisement indicate that the device is the subject of investigational testing, along with the purpose of the testing.
There are also special requirements for the advertising of contraceptive devices under Section 24. This section interprets how the requirements of section 3(1) and (2) of the Act apply to these devices.
Any labelling or advertising claims which exceed or embellish the market authorization are not permitted. Complaints related to false or misleading advertising are addressed by the Health Products and Food Branch Inspectorate.
Proposals for consideration
The following proposals are provided for discussion purposes and reflect the principles put forward for drugs above, and also relate to topics from previous discussions:
- No person shall advertise a device for which the market authorization is suspended or revoked, or for which a particular intended use has been suspended or revoked.
- No person shall advertise a device for an intended use that is not included in the market authorization for that device.
- Advertising of devices that have a market authorization with special conditions shall indicate the special conditions of authorization in the advertisement.
- Any advertisement shall be set out in such a way that it is clear that the message is an advertisement.
- Persons who receive compensation of any kind from a market authorization holder to promote, either directly or indirectly, a device must declare such an affiliation.
- The advertising of a device shall not exaggerate its benefits or minimize its risks, but provide factual information so that practitioners or consumers can make an appropriate and informed choice.
- Advertisements for devices shall be consistent with the market authorization for the device and its approved labelling, including, as appropriate:
o Intended uses
o Potential benefits, including efficacy
o Directions for use
o Duration of use
o Potential harms, including adverse events.
- Any advertising claims, both direct and indirect, must be consistent with the market authorization, its special conditions (if any), and be supported by the scientific evidence submitted with the application for market authorization. This includes, but is not limited to, claims regarding:
o therapeutic comparisons with other products
o results of clinical tests
o reduction of risks and adverse events.
- Visual representations and graphics included in advertisements shall not directly or indirectly represent intended uses or potential benefits for which the device has no market authorization.
- Advertisements for devices shall not be directed at children.
- Misleading advertising
o Advertisements are considered to be misleading if they:
- represent a guarantee of benefit or an absence of any risk (e.g. statement of being “safe”)
- represent that a device:
- has components that it does not have, or
- does not have components that it does have
- represent that the health of the user can be enhanced by the use of the device.
- Where Health Canada is of the opinion that advertising is in violation of the regulations, it may issue a notice of direction to the market authorization holder instructing it to:
o cease such advertising immediately, or
o modify such advertising to bring it into compliance with the regulations.
- Such a notice of direction shall be issued in writing and include the following:
o Name of the device
o Advertisement in question
o Reason(s) for the notice
o Date on which the advertising in question must cease, or be modified
o Instructions concerning requests for representations
o Date by which such a request must be made
o Contact name and information.
- The market authorization holder may request, in writing, the opportunity to make representations to Health Canada considering the notice of direction, by the date indicated in the notice of direction.
- After hearing representations, Health Canada will provide in writing to the market authorization holder confirmation if the notice of direction remains or an instruction regarding acceptable modifications to the advertising in question.
- Health Canada may suspend the market authorization of a device if a market authorization holder is not in compliance with regulations regarding advertising or is not in compliance with a notice of direction.
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