QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared.
Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary. We can’t continue to develop drugs the same way as we have done before. We need a 21st-century approach that puts patient safety first.
A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).
The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety.
“Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers, and distributors.
Can patients really be confident in pharma supply chains?
The FDA estimates that up to 40 percent of finished drugs used by US patients are manufactured abroad, and 80 percent of active ingredients and bulk chemicals used in US drugs come from foreign countries.
Up to 90% of drugs now sold in the US and UK are generic. Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiraling rises in generic drug prices and shortages. Most of these generics are produced outside the US and recently there have been numerous recalls of generic drugs because of the failure of quality control.
Outsourcing, which has become mainstream in pharma, has also led to competition that doesn’t always benefit patients. It’s actually very simple; the more outsourcing in product development and product compounds the greater the risk of a drug failing clinical trials or patients getting a drug that doesn’t meet GMP standards.
The question that I kept asking was why? Why would a pharma company take risks like these? The answer lies in both an outdated way we develop prescription drugs and the continued quest for the next big blockbuster. With all the COVID vaccines that are being produced can we really be sure we are getting what was developed and approved? The recent failure of a J&J suppliers plant that led to the disposal of millions of doses should be a warning to us all.
One way to ensure that pharma doesn’t take any shortcuts is to grant patent protection when the drug is approved not when they start work on it. This would allow them to take as much time as necessary to get it right. The second option is to do more random testing of prescription drugs already on the market to ensure they meet FDA guidelines.
When pharma outsources any part of its supply chain they are gambling with our lives. As Mr Rees writes in his book it wasn’t always like this but if we don’t get more people to listen a looming disaster is just waiting to happen. How many patients would accept a medication if they knew most of the raw materials and testing was done outside the US?
Supply chain issues in healthcare are damn scary.