As part of my “educate myself more” attempts, I wanted to dig into an article about the FDA a little deeper. The most confusing part of my coverage of diabetes in the decade that I’ve been doing this has easily been anything to do with the FDA.
It has always been confusing to me.
But, this article is pretty straight forward, the practice being talked about is a bit, well, shady.
Blocking Generics
So, when a company submits a generic drug to the FDA, the brand name pharmaceutical company will help organize citizen petitions to the FDA which will bog down the process of getting said generic approved by the FDA.
I get it, it makes sense, but it seems like a pretty sketchy move in my book.
The FDA announced last week that it is going to crack down on these practices.
FDA Commission Scott Gottlieb is quoted in the article saying,
while the record shows that citizen petitions have rarely delayed specific generic drug approvals, there’s no doubt that the process requirements associated with … petitions can add to resource burdens on the generic drug review process.”
Another tactic that brand name companies use is to withhold samples from the generic company. According to the Washington Examiner article,
“a generic company needs up to 5,000 samples of a brand name drug to complete approval testing.”
These both seem like old school pharmaceutical tricks that have probably been used for a long time, but I don’t like them and I like the crack down.
Building the Biggest Building
I’ve used this example in the past, but there are two ways to have the biggest building in town.
1. Knock down the current biggest
2. Build the biggest building in town
What does that mean?
You can either become the best by trying to knock down the others and cheat and get ahead by putting them down.
Or
You can become the biggest building by putting in the work, making a better product and just dominating your competitor.
I get it, once a generic comes out, you’re not going to make as much money as you will if there’s not a generic, but you know this going into launching a new medication.
What are your thoughts on this? Are there any other sneaky little tricks played on the FDA that are worth discussing?
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