Low-cost generic drugs play a critical role in controlling escalating healthcare costs. With the vast majority of generics made partially or wholly overseas to capitalize on lower manufacturing costs, the adequate oversight of foreign manufacturing requires regulators to overcome significant geographic and cultural barriers. This is easier said than done.
To begin with, unlike most other consumer products, drugs work through a largely hidden process. If a car is a “lemon” and not fit for use, often it is apparent. Drugs, on the other hand, are complex chemical and biological molecules. They are formulated in technically specific amounts to react to hidden physiological processes within our bodies. This makes it hard to tell if a drug is a “lemon,” or in the words of pharma, the drug is “adulterated.”
Regulators worldwide answer this challenge by standardizing the process to formulate and manufacture drugs. Carefully controlled systems provide a high degree of confidence of reproducible, high-quality drugs. These processes are called current Good Manufacturing Processes (cGMPs). They ensure that the medicine meets specific requirements for identity, strength, purity, and quality. cGMP requirements apply to every aspect of manufacturing, processing, and packaging the product.
Adherence to cGMP is maintained through regulatory inspections. In the U.S., FDA frequently uses surprise inspections to ensure compliance. These inspections typically include a review of a company’s systems, processes, and records. FDA inspectors interview employees to verify that the company’s records are factual.
Regulatory inspections outside of the U.S, present jurisdictional and temporal challenges. A manufacturer located abroad receives advance notification to access the facility and often assists in procuring Visas for international travel. In many cases, inspectors seek assistance from the manufacturer to help with foreign languages, different cultures, and transportation to remote areas. These challenges remove the element of surprise which FDA uses to its advantage within the US. As FDA warning letters document, removing the element of surprise provides opportunities that can lead to skewed inspection results, even when manufacturers fail to follow cGMP.
Establishing foreign FDA offices better detects cGMP violations through more responsive action. In this way, FDA has offices in India and China and, more importantly, it has inspectors located within its Mumbai office.
These are significant steps. What remains, however, are inherent challenges such as language/dialect barriers, local systems and cultural differences. When visiting remote facilities, inspectors often rely upon manufacturer’s assistance for basic communication and transportation needs. These are systematic challenges that need to be addressed holistically because they impact the inspection process and, ultimately, the efficacy and safety of drugs consumed in the U.S.