The FDA is now writing up “guidance” for how reps can discuss “non-approved” use of meds and devices.

https://www.medpagetoday.com/special-reports/features/107096

First off, Medpage today is pretty swampy these days. They are definitely funded by the dark side of sCiEnCe. But I still check in with the page daily to see what kind of BS they are peddling. Know they enemy as they say.

This article is particularly concerning. The FDA has always had a set of rules for the scourge that is big pharma in what they are and not allowed to discuss about their product. They have to stick to the FDA approved talking points for which the drug/device was clinically approved for. It is a violation to discuss anything the drug/device is not approved for.

Well, they apparently want to change that. They are creating a set of “rules” that allow a discussion and engagement with providers about non-approved uses of a drug/device. This is a big problem. This is a breach of the small shred of ethics that pharma had to adhere to. Discussing off label is going to lead to more reps visiting my office to discuss “alternative diagnoses” for which their drug is the BEST and MOST AMAZING thing to try for it.

Speaking of pharma junk, there is a new brand version of Adderall on the market. It is in 15/25/35 mg dosages only. Here is their website: https://www.trisadhd.com/dyanavel-xr-tablet/

What makes this a fun story is that I don’t talk to pharma reps in my office. In fact, I put a mini fridge and microwave in my office so I can avoid them all together when they swarm like flies on shit at the lunch hour in my office. One day this last week, I see a woman who was I swear to God I am not kidding here, was dressed head to toe in the same magenta pink color as the Dyanavel literature. She kept pacing back and forth trying to catch me while I was going back and forth to the lobby to get a patient. She never caught me for what its worth. Anyways, one of the other providers did stop and talk to her and her sales pitch was so forceful, I overheard her saying “will you commit to writing 5 prescriptions of this in the next week?“. The providers reply was great, they said “I can’t commit to anything” and walked off.

So when you combine that example with the new FDA plan to add ability to discuss some off label use of drugs/devices, can you imagine how pushy it is about to get? I may have to take the long way to the lobby to avoid even walking past the break room door when these types of pushers are in the building. If it were up to me, they would all be banned from ever coming in.