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TZ Donating Member (1000+ posts) Send PM | Profile | Ignore Tue Jul-14-09 10:06 AM
Original message
Biosimilars legislation
Are you guys familiar with this piece of legislation that Congress is considering? It basically shortens the time a drug or biological molecule can be considered "proprietary" from 12 years to 7 years. The goal is I suppose to make cheaper generics available to consumers.
My company is pushing for us as employees to "call our repersentatives" and say we feel its not good for us in the biotech field. I'm not comfortable with this. There is also a lot of advertising by the Biotech industry on the radio on this. Normally, I would ignore this as the BS that sadly comes along with working in this industry BUT I feel there is one relevant point. There is a lot of counterfeit drug makers overseas especially. Or those who don't bother to do any kind of safetty and efficacy testing. I could see a lot of manufacturers in India or China taking advantage of this and selling stuff that might not be in the best interests of the consumers....
So I am torn...Opinions? Not sure how objective I can be, though I'm not convinced I'll lose my job if this goes through like some seem to suggest here..:eyes:
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semillama Donating Member (1000+ posts) Send PM | Profile | Ignore Tue Jul-14-09 11:13 AM
Response to Original message
1. How would this effect counterfeit drug makers at all?
I guess I don't understand why a reduced waiting period would make a difference if they are already making counterfeits.
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TZ Donating Member (1000+ posts) Send PM | Profile | Ignore Tue Jul-14-09 11:20 AM
Response to Reply #1
2. Here's how it works
They could change a small molecule on the drug and say it was the same, without any testing of any sort in terms of safety and efficacy. Although generics are generally the same drug, alot of times they are not exact duplicates of the patent drug..they are however supposed to work the same (this is something that the public doesn't generally know, its not a secret, just one of those things) and its why sometimes generics don't work as well on some people. Hasn't had a clinical trial technically.
When I say "counterfeit" I mean the near molecular structure "counterfeits" which this bill would possibly make easier and legal.
Yeah this is a complex issue. Which is why I wanted some feedback here.
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drm604 Donating Member (1000+ posts) Send PM | Profile | Ignore Tue Jul-14-09 08:52 PM
Response to Reply #2
3. But what does reducing the time from 12 to 7 years have to do with that?
Wouldn't reducing the time make this less likely? Once they can legally make the generic, why counterfeit?

Think about what you're saying. It almost sounds like you've bought into the industry propaganda.
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TZ Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jul-15-09 07:29 AM
Response to Reply #3
4. I was arguing this point with someone who has bought in the propaganda
Playing devils advocate here. I was trying to reproduce his arguments objectively. I see now its difficult..
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