a reply to:
Thoughtful2
Kill Shot
Painting a picture - just how dangerous this broken system is.
NECC was the pharmaceutical compounding manufacturer who was responsible for the deadly fungal disease.
When the Supreme Court made that ruling, that left the only oversite of these compounding pharmaceutical companies in the hands of State Pharmacy
Boards. Nothing like having a fragmented system. But wait it gets better.
"The State Oversight Board was an extension of the pharma industry- meant to ward off federal scrutiny." The compounding companies made the board and
who could possibly think this > "Hey, we're going to make a little board thing and we'll go around, just you and me, and we'll go into your pharmacy
and say "You're good." And then you'll come to mine." Page 20
One would think that the FDA would have been watching NECC like a hawk because years earlier there were problems and the concerns went to the
Oversight Board. So what did they do? Launched a committee to update regulations but then put Cadden, from NECC on the board. Page 23
There were just so many red flags. The manufacturing facility was in an old building "located between a swamp and a pond and sandwiched between a
concrete block maker and recycling center with mattresses and discarded furniture in the parking lot." I don't want to judge but that doesn't sound
like the best location to manufacture sterile drugs.
There was no inspection of the facility.
There was no tracking where the drugs went. Page 16
"They took full advantage of all the loopholes and not only provided drugs to Drs. offices but also went after the big hospital pharmacies with a
"killer" salesforce. There was one safe guard- the drugs had to be directly tied to a specific patient and NECC had to maintain records of this.
"Sending out drugs without patient prescriptions is illegal." Who cares when no inspections are conducted.
As they say never let a good crisis go to waste. Another agency
the U.S. Pharmacopeia decided to finally updated the safety guidelines about the
manufacturing of compound drugs. I'm wondering about the timing here??? Now they had to be made in a clean room and that meant hospitals would have
had to invest some serious $ in adhering to these guidelines. Since it is always about the $ the hospitals went with the outsourced products.
Just to point out but none of these hospitals inspected the source of their drugs.
This is just sooo broken.
Another underfunding case- The Massachusetts Board of Registration [responsible for detecting drugs sold without patient prescriptions] only had 3
investigators for 100 pharmacies and 57 other compounding pharmacies. We can expect the same in other states. Once again no safe guards over who can
serve on this board. What a surprise that there is a direct connection to one of the members and NECC. Page 20
What about the pharmacy inspectors? They never flagged the location of the pharmacy so why bother training any of the inspectors on how to inspect the
sterile rooms.
"They don't know what they are looking at. They have no clue. They go around, like, 'Barry, this place looks great." he said with a snicker."
The end conclusion is that through all of this there were no consequences to NECC for violations to anything from drug manufacturing, matching
patients with prescriptions or staying within the 5% limit, that is until people died.
The FDA is criminally responsible by not enforcing their own 5% rule and they are still not enforcing it. During the last three years there has been
even less oversight if that is possible.
Could it be that this these weakly regulated compounding companies were turbo charged right before the launch of the plandemic?
I'm left wondering and maybe this is just me but all of this looks like a plan to dismantle our healthcare system orchestrated from the very top.