Judge Amy Coney Barret, Governor Chris Christie & the Branchburg 483
A Study in Coincidence - in NJ
During the Senate hearing for Judge Barret last week, there were a flood of legal articles. One I noticed on last Tuesday morning focused on several of her noted legal positions, including a novel analysis that posited there is no constitutional basis for denying felons the ability to purchase firearms. (While the 14th Amendment has been held as barring their right to vote, there is no wording seen as supporting to suspending their rights under the 2nd Amendment.) What made me remember the article was a comment that was included - "What is the societal good served by denying Sam Waksal and Martha Stewart the right to buy a gun?" It made me remember something I hadn't thought of in years - the ImClone insider stock trading case. (If you don't remember that, background here.)
I put that article aside but then another event occurred. That evening Reuters reported on 483's at a Lily site, which was actually the ImClone site in Branchburg, NJ. (I posted on one of them last week.) It was interesting to have that site be mentioned again, and while it was still fresh in my mind. Quite a coincidence but there was one more to follow.
领英推荐
This past weekend we found out that former Governor Chris Christie was not only in Morristown Medical Center due to Covid-19, but he had spent a week in the ICU. (The initial story was just that he had "checked himself in out of an abundance of caution.) Beyond that, like Mr. Trump, Mr Christie was treated with remdesivir AND a monoclonal antibody cocktail. This cocktail however did not come from Regeneron, across the Hudson in New York state. The medical staff at MMC only need to request compassionate use from the ImClone facility just 45 minutes away down Route 287 / 202, in Branchburg NJ.
This was only a set of coincidences, but even though I have driven past this plant over a hundred times in the last several years, I hadn't given it much thought. Given what we are seeing this week, there should be more to come. Now there will be current events, not simply coincidences. Stay safe, stay healthy!
Director, WakeUp to Quality | Chair, GAMP Global Steering Committee | Advisory Board, Valkit.ai
4 年Interesting points, thanks for sharing John.
Computer System Validation & Data Integrity
4 年Luis Chavarria , I presented this as a study in coincidence, but I must agree with you about the position of NJ, vis a vis the FDA. The OPQ Ops Division I office (just up the road in Parsippany NEW JERSEY) "kicks butt" because, sadly, it's a "target rich environment."
Former FDA Officer Freelance FDA Consultant
4 年John English, HCCP Well I will start with my opinion of this entire description of this affair, it sounds like a long winded way of saying the world revolves around Joisey. As to the ACB thing, that is better left to the piercing of the protective bubble with spears of reality. Either way yes Jersey, has established itself as The boss of all things FDA.
Pharma/Biotech Consulting & Project Mgmt | GxP, Quality, Clin Ops, Vendor Oversight, Inspection Readiness, TMF
4 年I thought ACB was brilliant during her questioning and appeared well versed in the theory, philosophy and application of her job. Unlike the quality departments at these pharma sites. The more the American public might learn about the dirt behind the veil of drug development (particularly manufacturing) the worse it’ll make the industry look, sadly. Good inspection job by the FDA! It’s too bad FDA leadership needs to have political appointees and revolving door executives involved at all in its operations.