QDIS Blog

Recently the FDA announced they were changing how they review generic drug applications.

FDA Offers Speedy Approval for Some Drugs

Previously, it was first come first serve and applications were held in a que. They were then reviewed, the oldest to the more recent and the median timeframe was about 16 months.

Now however,while still using the FIFO approach, the FDA will prioritize some applications based on “their public health impact”. This sounds good and will indeed help but I’m somewhat hesitant to give it a rousing endorsement. Until I hear more details on what criteria is used, it seems ripe for abuse and/or manipulation. The days of the generic drug scandal are not that far gone and those lessons learned should not be ignored.

I’m hopeful that this will indeed be an improvement but will keep an eye out to see how it is implemented. It should be noted that this will only apply to approximately 25% of the generic applications.

For those interested the 5240.3R Review Order of Original ANDAs, Amendments, and Supplements (pdf) is available online.

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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.

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