When the regulations call for promotional materials to be accompanied by adequate directions for use, for pharmaceuticals we are talking about the PI.
The question is, what do companies think "accompanied by" means? There are really two general categories: electronic pieces and hard copy pieces. Here are some thoughts about each:
ELECTRONIC PROMOTIONAL PIECES - Non-narrative
There are many kinds of electronic promotion: e-mails, websites, electronic ads, social media, internet videos and TV/radio ads. In all but the last category, the PI is normally 'provided' by including a link to the PI. That link normally goes to a pdf version of the PI on a product promotional website. If this method is used the link should probably go DIRECTLY to the pdf of the PI and not to the homepage of the website. Other methods exist like creating a hidden website that only has the pdf of the PI and then linking to that single webpage website. By standard practice, for TV/radio ads the viewer/listener is directed to a printed ad (or a website URL) that contains the PI. OPDP has said that internet videos are more like websites than TV ads and, in fact, if a TV ad is placed on the internet (e.g., on YouTube) a company should provide a link to the PI page ON the internet page with the video instead of within the video telling people just to go to a magazine to find the PI as they do with TV ads. In other words, OPDP feels that once a TV ad is on the internet where space or time is not limited, normal internet rules regarding the inclusion of the PI apply.
ELECTRONIC PROMOTION - Narrative
During a product promotional presentation like a sales presentation on a tablet/laptop or a product promotional slide show, a hard copy of the PI should be handed out at the beginning of the presentation. In these cases it would likely not be sufficient to simply show the PI on the presentation screen as that would likely not represent ADEQUATE directions for use.
NOTE: If you are presenting a webinar there are four options I have seen used:
- E-mail the PI to each webinar registrant with the e-mail confirming their registration
- Shortly before the webinar is supposed to start e-mail the PI to all participants
- In the confirmatory e-mail provide a link to the PI
- For hard copy confirmations, include a link to the PI on a postcard with appropriate text letting the reader know what the link is to or for a letter confirmation, include a copy of the PI
Companies should decide which they feel is best for them logistically and for regulatory compliance.
PRINTED PROMOTIONAL PIECES
For printed materials, there are a number of different ways that companies provide PIs with their promotional materials:
1. They print the PI on the promotional material
2. They glue the PI to the promotional material using a sticky, glue-like substance that allows easy removal of the PI
3. They include the PI in a sleeve between two pages
4. They include the PI loose inside a multipage piece
5. They provide the PI separately (but at the same time) as they distribute each promotional piece
There are reasons that companies have for using each of the above. Based on my experience here are those reasons as I understand them as well as the pros and cons of each one.
1. Some companies feel that it is better if the PI is part of the piece so they know the viewer will receive the PI IF they receive the promotional piece. Also, for a magazine ad, the inclusion of the PI is a requirement (along with the major statement important information (including safety information) about the product. In this case a company would have little choice but to buy a couple of extra magazine pages to print the PI. As indicated above, this does help the company if they are running TV ads about the product as it gives them a place to point viewers to see a copy of the PI.
pros -You will never have a promotional piece given out without the PI; pieces tend to stack better than if you use the glue idea.
cons - If your PI undergoes a substantial safety labeling change that the FDA deems important enough to require the company to implement immediately, you could end up trashing a whole bunch of your promotional pieces (or, in the case of a TV ad, having to reshoot the ad). Reprinting (or reshooting) these could eat up a good amount of a marketing budget, especially if it is a popular piece.
2. This seems to be very popular and provides a great way to get the PI (usually folded up to a small size) attached to the piece but easily removed from the piece if someone wants to read it.
pros - The PI is affixed pretty tightly to the piece so it is unlikely to be accidentally dislodged. As above, this eliminates a lot of the human error in proactively giving out the PI. In some cases, it also makes it possible to replace the PI with a newer version if necessary, although this is not always possible.
cons - Promotional pieces end up with a lump in them, making them harder to store and bulky to pass out. It may not be easy to remove the glue and replace with another PI if a PI change is mandated so you could end up trashing your promotional material.
3. This requires a piece to have two pages permanently glued together at the sides and bottom creating the pocket.
pros - The best option if you want the PI to be non-obtrusively included AND easily swapped out if a PI has to be replaced.
cons - Probably the most expensive way to include a PI as, for a single page sell sheet, you now have to create a pocket which might more than double the cost of printing.
4. The lowest tech option which can involve the PI (flattened out to make it fit better between pages) being added after printing or can involve the person distributing the promotional piece to a customer or patient actually slipping the PI into the piece before they distribute it.
pros - least costly of the ones so far and represents the easiest option in terms of replacing the PI if replacement is necessary; some companies even provide a set of PIs in a stack like a notepad where a PI is just peeled off every time it is needed (thus, if the PI is changed, the pad of old PIs is just destroyed and replaced with a pad of the new PIs)
cons - this represents one of the greatest risks for the PI not being given out with the promotional piece so when this method is used, the PI is almost always provided with piece as it comes from the printer; most companies still don't feel comfortable with the possibility that some employee may forget to include the PI when they distribute a piece.
5. This separates the act of giving out the promotional piece from the regulatory requirement of providing the PI. In additional some companies feel that all they have to do is OFFER the PI, whereas other companies feel they have to provide the PI. For the former group, having PIs available but not included cuts down printing costs of having to include the PI, even loosely, with the promotional material.
pros - If a company feels that their employees are well trained enough, this option represents the most cost effective and versatile (in case of a PI change) way to satisfy the regulations
cons - This option provides the greatest opportunity for someone to forget to provide the PI with the promotional piece and probably requires the most oversight of these 5 methods to make sure a company is being compliant in providing the PI to the person getting the promotional piece.
FINAL THOUGHTS
As product promotion changes some of the above methods of promotion may become obsolete. They key for me is to make sure that the person receiving the information has access to the PI that is commensurate with the nature of the presentation of the promotional materials allowing, of course, SOMEWHAT for limitations in the nature of the promotional materials. Notice that I said 'somewhat' as OPDP has said repeatedly that limitations created by use of certain methods of promotion does not eliminate the requirements for fair balance and providing adequate directions for use. As companies move into new types of promotion they should concurrently develop internal standards for providing the PI (and, of course, fair balance). In many cases those standards evolve over time for a particular medium but it is way better to have developed your company policy than to do nothing and wait to see what other companies are doing. Or, you could just ask OPDP what they think!
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