Why you should want to know more about the pharmaceutical supply chain
Your life could depend on it...
I know what I’m taking about
What has been going into people’s bodies over the last four years, in the way of injections, was produced by supply chains. Yes, without a supply chain, there would have been no SARS-CoV-2 injections—none, zero, nil, zilch, nada. It’s the same with cars, planes, phones, and any other physical product, just they don’t go inside your body, the injections did…
…that makes it vitally important that the supply chain is proven safe BEFORE going into people’s bodies. The declared global emergency was no reason to ignore that, because a hastily constructed supply chain for a pharmaceutical or biologic product has the potential to kill and main far more people than a virus of unknown origin.
I posted on the matter in May last year:
Pharma supply chains can and have killed people—stay vigilant
It begins:
THE HEPARIN TRAGEDY
In 2007/8, pharmaceutical [and biologic] supply chains became the subject of global debate, but for the wrong reasons. A tragic event occurred that shocked the world into realizing that pharmaceutical supply chains had the potential to kill and maim unsuspecting patients.
That led to the Falsified Medicines Directive being passed in the EU and FDASIA Title VII Drug Supply Chain Provisions being passed in the US. For those who wish to dig deeper, below is the FDASIA Title VII Overview. This section is important:
Sec. 711, Enhancing the Safety and Quality of the Drug Supply
This section clarifies that current good manufacturing practice (CGMP) includes having oversight and control over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of ingredients, raw materials used in manufacturing, and finished drug products. While this provision is self-executing, FDA is revising existing CGMP regulations, consistent with this provision, to ensure oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of components used in manufacturing finished pharmaceuticals. This revision will update and harmonize requirements and improve detection of and response to emerging product safety and quality signals.
This places absolute responsibility on Pfizer/BioNTech and Moderna, as examples, to have full oversight and control of the entire drug supply chain.
FDASIA (pronounced FADASIA) is a Legislative Act passed by US Government and it has NOT BEEN REPEALED.
How is the supply chain proven safe?
The way the supply chain must be proven safe initially is by the developing company producing a small quantity of drug (say 10 kilograms of litres) to carry out toxicology and other safety tests in animals (would rather not test in animals, but that’s the way it works today).
By the time the supply chain is constructed and test results reported back, at least two years have gone by, possibly three. Remember, these aren’t virtual supply chains where everything works by magic. These are physical constructions put together by real employees who must respect the laws of physics and other world realities, such as procurement lead-times.
As the production process is scaled up for trials in humans and product launch, so the safety testing must be repeated. This is because there can be changes to the compound’s molecular structure during scale up that can turn a previously safe compound into a toxic material.
Trials in humans typically take seven years as the supply chain is extended into the final dosage form and the finished product presentations.
The developing company (clinical trial sponsor) must submit every detail of the supply chain to the regulatory authority (FDA/EMA/MHRA etc) in an application for a license to sell. This is known as the chemistry, manufacturing and controls (CMC) data, see:
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
Given the nature of these modified cell gene therapy products, and the complexity of the bioloigs supply chain, gaining approval for the supply chain from the regulatory authority would be a massive challenge when compared with simpler products. Even for the simpler products, it typically takes a year to a year and a half for review and evaluation of the documentation.
How can I say this so confidently?
Professional supply chain management (SCM) in the pharmaceutical and biologics industries is what I do. I’ve been doing it for over 40 years. I even wrote a book on it, published by the global US academic publisher Wiley in 2011, titled:
Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics.
I’m not asking you to buy it, as it’s priced for industry specialists—I just want to assure you that I know what I am talking about.
If you believe me, why not share this to people you think may want to know?
If you want to hear more, much more, on the pharmaceutical or biologics supply chain, so you can work out what’s been going on for yourself, then why not subscribe?
Thanks for listening,
Best regards,
Hedley