QDIS Blog

This article talks about a recent press release from both Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) regarding regulation of foreign active pharmaceutical ingredient (API) manufacturers.

US and EU pharma trade bodies slam poor regulation of foreign APIs

Both have valid point that although regulations require inspections on a regular basis, the reality is that the schedule is rarely up to date. In 1999 there were 242 manufacturers who imported into the US but had not been inspected.

The dramatic rise in the number and amount of API’s sources in India or China means that both US and European regulators, already behind, will likely only get worse before it gets any better. This does indeed mean that the possibility of something adverse occurring is increasing.

My main point here would be that the FDA is underfunded for the work they do. Congress likes to increase their responsibility without increasing their budget to do so. Foreign inspections seem to be one of the first items to be cut and I don’t see that changing anytime soon. I personally think it is going to take a major incident before something changes. Unfortunately it will like involve people dying before action is taken. Historically, almost all major pharmaceutical regulations in the US come after a major incident involving deaths. Until then, nothing happens proactively.

Technorati Tags: FDA, FDA inspection

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