Dr. Scott Gottlieb - Commissioner - Food and Drug Administration
The FDA is planning on putting out a shaming website available to the public and updated regularly. This website will hold a database of the companies who are getting in the way of cheaper generic drug manufacturers and developers. Our health insurance is partly as high as it is because of the pharmaceutical companies increasing brand name drug prices sometimes as much as 800%, we have seen this recently in the case of Valiant Pharmaceuticals and others who have had the finger wagged at them during congresional hearings.
Unfortunately the government cannot step into the middle of the companies actual pricing, and I'm no spokesperson for federal intervention into capital business, but when you cannot afford your lifesaving medication and there is no other option, we ay enough is enough.
This is all happening Today May 17th, here is the link to the online database. It lists over 50 companies who ruthlessly blocked the production of cheaper generic drugs, patent information, submission to FDA data and much more.
Being in the medical field I see many of these drugs on a daily basis, one for instance is Truvada, this is a cocktail of three different medications used to treat HIV. This is the primary drug used on first contact with HIV or first developing contact with HIV. At more than $1000.00 per month this drug literally puts a price tag on your life. Heres a real world example. I act as the phlebotomist for my office on occasion, if I was taking a blood sample from a patient with HIV and accidentally got stuck by the blood draw needle I would immediately need to take Truvada. I currently have no health insurance because I cannot afford the insanely high price they quoted me, so I would most likely acquire HIV and suffer the outcome from that. Now thats a life or death alternative, I would be forced to pay out of pocket and likely sell everything I have to stay alive. Somethings gotta give.
How do the brand names "block" the generics from going to market?
Well it all starts with the FDA and a program called REMS. (risk evaluation and mitigation strategies) This basically means that when producing a drug with dangerous side effects you have to mitigate the drugs availability and ensure it is used safely. They hide behind this and refuse to send samples to generic drug makers. This is the effective blocking technique used.
So whats being done?
Well firstly the generic drug maker would send a letter to the FDA asking if in fact a REMS is in place for a certain drug they want to make, the FDA would provide information stating weather or not the brand name is protected by this or if the generic company has the green light to go ahead with the generic drug. Dr. Gottlieb stated that soon the FDA will just start issues waivers giving the generic companies the go-ahead to start production, effectively bypassing this whole REMS ordeal. This is a case of a good system (REMS) being turned on its head and used for ill intent and selfish gain by brand name pharmaceutical companies.
We know this doesn't have allot to do with medical marijuana so far, but think about what would happen if big pharmeceutical companies took over the medicinal cannabis production and extraction process. So far the prices have been kept low by high supply ratios, which is great for patients. The downside is since it is not yet federally legal insurance cannot cover any of it. This is a double edged sword, we have a grass roots movement with quality control officers here in Florida overseeing everything, state of the art C02 extraction facilities, and a friendly educational atmosphere to buy the products. The downside is that this process is all cash based which becomes a big problem for the growers, producers, dispensaries and extractors. So far the program has gone very well, all of my patients have been very happy, and many have found real relief, and been able to stop taking there addictive, harmful medications. So read the list, do your research, and leave comments below.
This is just my interpretation of what has transpired.
To read the other stories:
MedClub by Dr. Jenn
224 Datura Street
Licensed Medical Marijuana Physician