3 ms·

Here is an idea: anyone can make a generic drug if an independent FDA lab cannot tell the difference between unlabeled samples from the new manufacturer and unl

by api 6y ago

Here is an idea: anyone can make a generic drug if an independent FDA lab cannot tell the difference between unlabeled samples from the new manufacturer and unlabeled identically packaged samples from a currently approved manufacturer. You would need to do this testing continuously at random, so the FDA could just charge a fee for this. It would be way cheaper than full regulatory compliance.

pochamago 6y ago
I like this idea, that seems like an elegant solution I haven't heard before.
mc32 6y ago
“Anyone” ends up with cases where packaging operations are run right next to shipping, meaning all kinds of contamination can happen. Avoiding this situation means costly facilities with costly, inefficient but necessary regulation.
javajosh 6y ago
Sounds good to me, but I don't think it would fly. It's too reactive. The FDA needs to be able to take proactive steps to avoid mistakes. So, I take your idea and raise you: Put cameras everywhere in your lab/factory, and give the FDA inspectors 24x7 access to every feed. This is in addition to allowing onsite random inspections, of course. I mean, as a consumer, this would make me feel warm and fuzzy about buying drugs from that company. I mean, you could even allow the public access to those feeds, as a marketing tool!
- javajosh 6y ago
  You might even pay someone like the Vertitasium guy to do a walk through of how everything works, and then give the public access to your feeds.
deleted 6y ago
[deleted]
pvaldes 6y ago
> anyone can make a generic drug if an independent FDA lab cannot tell the difference I see a few problems with this plan 1) Makers would lose interest in research of simple drugs easy to clone or, more probably,... They would fight back introducing additives in the mix, useless except for the sake of making the recipe much more difficult to copy, or to aim for a product recognizable for the public (i.e viagra must be "blue pills" not green pills, etc, but the blue colorant is in fact useless except for marketing purposes). 2) Because an increase in additives the number of crossed interactions with other medicines would raise exponentially and would be much more complicated to predict in multiple treatments 3) Potential collateral effects and allergies could increase also. And it creates a system prone to corruption, of course (The makers can be blackmailed by the independent lab).

by api 6y ago

pochamago 6y ago

I like this idea, that seems like an elegant solution I haven't heard before.

mc32 6y ago

“Anyone” ends up with cases where packaging operations are run right next to shipping, meaning all kinds of contamination can happen. Avoiding this situation means costly facilities with costly, inefficient but necessary regulation.

javajosh 6y ago

Sounds good to me, but I don't think it would fly. It's too reactive. The FDA needs to be able to take proactive steps to avoid mistakes. So, I take your idea and raise you: Put cameras everywhere in your lab/factory, and give the FDA inspectors 24x7 access to every feed. This is in addition to allowing onsite random inspections, of course. I mean, as a consumer, this would make me feel warm and fuzzy about buying drugs from that company. I mean, you could even allow the public access to those feeds, as a marketing tool!

javajosh 6y ago
You might even pay someone like the Vertitasium guy to do a walk through of how everything works, and then give the public access to your feeds.

deleted 6y ago

[deleted]

pvaldes 6y ago

> anyone can make a generic drug if an independent FDA lab cannot tell the difference I see a few problems with this plan 1) Makers would lose interest in research of simple drugs easy to clone or, more probably,... They would fight back introducing additives in the mix, useless except for the sake of making the recipe much more difficult to copy, or to aim for a product recognizable for the public (i.e viagra must be "blue pills" not green pills, etc, but the blue colorant is in fact useless except for marketing purposes). 2) Because an increase in additives the number of crossed interactions with other medicines would raise exponentially and would be much more complicated to predict in multiple treatments 3) Potential collateral effects and allergies could increase also. And it creates a system prone to corruption, of course (The makers can be blackmailed by the independent lab).