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Politics : Formerly About Advanced Micro Devices
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To: combjelly who wrote (889554)9/22/2015 4:20:29 PM
From: i-node  Read Replies (3) of 1576441
 
>> He has made it impossible for another manufacturer to demonstrate that its generic is as effective as the original. Do you think that a manufacturer shouldn't have to do that?

*HE* hasn't made it impossible. FDA has.

There is nothing at all preventing other manufacturers from using the same formulation for the drug and selling it. That would make it a simple chemical analysis problem to replicate the drug. But there is a reason this isn't happening. The FDA approval process is absurdly unwieldy for a drug that just isn't in demand.

In 2010 there were 12,700 scripts for it. No one wants it. In 2010, according to NYT, gross revenue from the drug was under a million dollars. Simply put, the drug was seriously under-priced. It is a simple case of the drug being underpriced by GSK originally, other smaller companies saw an opportunity to make a profit, and they took it.

Sure, the drug is too expensive today. Part D providers and health insurance companies can just say, "We're not paying." And the price will come down. That's what should happen. If not the FDA ought to get out of the way and allow another manufacturer to replicate the drug.

I do not believe that every generic ought to have to go through a high-dollar, bureaucratic approval process.

I would also point out that when "BIG PHARMA" (GSK) had it, it was selling for $1 per tablet. This is not some kind of abuse by the Pharma industry. This is a lone wolf who saw an opportunity to capitalize on FDA bureaucracy and an under-priced drug he found. The problem is easily solved if FDA were agile enough to deal with it.
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