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Thanks! Like any govt site, super user friendly. 😆 trying to find info on what’s allowed in CRM/“loyalty” programs. Like giving swag, etc.
No can do on the swag, the Sunshine Act made it mandatory to report all payments from Pharma to prescribers, including monetary value of all swag. The reporting requirements got burdensome.
I don't know why no swag given to patients - it may be considered unethical.
I've been in pharma ad agencies for a while as CD and AD. I'm not aware of any book or easy YouTube video to get quick answers. The FDA site is your best bet. It's cumbersome but the answers are there. Regulatory rules change so that's really the only way to get updated info. I've had luck actually calling the FDA when I couldn't find what I was looking for. You could ask your regulatory person. It depends on what aspect of guidelines your looking for...art, copy, editing, regulatory, etc. There are some third-party sources that offer courses and certificates on understanding guidelines on pharma advertising, internet promotion, and social media but I think you're looking for immediate answers, correct? What's your specific question about giving swag?
Been looking for a primer for new hires in the industry. Comment on topics they think it should cover
I’ve been told it’s possible, as long as there’s a medically relevant reason and it’s not over a certain dollar value. (Not a ‘here’s something for taking the Rx’ - that would be illegal)
(This is kind of what I mean about getting different answers. Everyone seems to be super confident in their answers yet no one can point to “it says so right here” and I have received maybe 3 different variations of answers from 3-4 different people ). Actually spent several hours trying to find anything pertaining to this on the FDA site over the weekend and didn’t find anything. I would LOVE to find the actual regulation/guidance.
Not trying to be rude. It’s just frustrating for someone that wants to learn.
It seems your specific question is about swag for patients and you would like to get chapter-and-verse for any answer.
For starters: here is an article saying "payments are unethical." It comes with a companion article saying the opposite!
doi: 10.1136/bmj.39286.422639.be
But note, this is from the UK, FDA has no say.
There are a few US articles. The consensus seems to be the benefit of offering incentives is unclear. Ncbi.nlm.nih.gov/PMC/articles/pMC1939754/
Also, patient assistance programs are an incentive, but I think you are talking actual swag, like a t-shirt with the brand name. I would go back to my second link above, the ROI may not be great. Also consider, if this is the way a patient is retained, a competitor could offer more and lure the patient away. But drugs are not fungible, and it would be dangerous to create that perception.
With all this, it does not seem there is an FDA regulation against it, none of this conversation would happen if there were. Generally, FDA is about quality of medicine, not about finances or prices.
So yes, there is no clear answer, and the more I think about it, it appears likely FDA has no jurisdiction over this.
I do already - and 💯 agree. That has been a great way to understand current landscape with pharma.
I also learned a lot from our medical writers and AEs. Other than that, sitting in on review panels is very enlightening!
I would suggest becoming a member of the American Medical Writers Association. They have many FDA resources and learning resources.
Call OPDP directly and ask your question.