The drug was an injectable form of progesterone, and (I believe) it is unpatentable as it is a naturally occurring hormone. Its use had been grandfathered in as pseudo-approved by something like FDA's DESI program, which they're in the process of shutting down - after about 50 years. Since there is now one FDA approved version of the medication (the one for $$$$), technically, FDA can notify all other manufacturers that they are required to withdraw their matching but unapproved products. However, FDA has announced that it will "use [its] enforcement discretion" (read - not enforce this part of the CFR) for the time being. The company with their $$$$ cut their price to about $500, still too high, IMHO. Compounding pharmacists continue to make individual doses for the same roughly $20.TalonNYC wrote:Sliky, that's it exactly, by re-classifying the drug, they were able to extend the patent on it. That meant they can charge whatever they want, AND that their competitors cannot make generic branded versions of it. However, if the system wasn't in place, the drug company wouldn't have had incentive to test the drug to prove that it can be used for that purpose. Granted, they horrifically abused the system this time (and do so often) but there is at least some good that comes out of it.
RESMED gone wild - u need prescription to buy RESMED's mask
Re: RESMED gone wild - u need prescription to buy RESMED's mask
_________________
Machine: PR System One REMStar 60 Series Auto CPAP Machine |
Additional Comments: Encore Basic Software; Pressure >7 |
Howkim
I am not a mushroom.
I am not a mushroom.
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Yes, usually it's the inclusion of something else (like an antacid or some buffering agent) that creates the patentable "formula" and allows for the Rx restrictions. The system itself is rife with opportunity for abuse =(
However, it has led to some of the most innovative products that extend existing products - like Lexapro. Celexa works, but by refining the compound you get a more powerful anti-depression medication. The only reason Lexapro was developed was that the patent on Celexa was expiring (meaning it would go generic shortly thereafter).
So, as I said, I'm torn between wanting the innovation, but not wanting to stomach the abuse of the system. Especially now that it appears to have moved to cover the medical appliance world too.
However, it has led to some of the most innovative products that extend existing products - like Lexapro. Celexa works, but by refining the compound you get a more powerful anti-depression medication. The only reason Lexapro was developed was that the patent on Celexa was expiring (meaning it would go generic shortly thereafter).
So, as I said, I'm torn between wanting the innovation, but not wanting to stomach the abuse of the system. Especially now that it appears to have moved to cover the medical appliance world too.
_________________
Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: Simplus Full Face CPAP Mask with Headgear |
Mike Talon
http://www.miketalon.com
http://www.miketalon.com
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Ah, but this drug had been used for years off-label for pregnant women in danger of delivering way too early.
_________________
Mask: Quattro™ FX Full Face CPAP Mask with Headgear |
Additional Comments: PR SystemOne BPAP Auto w/Bi-Flex & Humidifier - EncorePro 2.2 Software - Contec CMS-50D+ Oximeter - Respironics EverFlo Q Concentrator |
Women are Angels. And when someone breaks our wings, we simply continue to fly.....on a broomstick. We are flexible like that.
My computer says I need to upgrade my brain to be compatible with its new software.
My computer says I need to upgrade my brain to be compatible with its new software.
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Yes, however without testing and approval, many insurance plans will not cover off-label prescription of existing drugs not explicitly designated for treating the condition in question.
Granted, your doc can just prescribe it for the "tested" diagnosis, and use it however they want, but that's a legal gray-area.
Like I said, the system is NOT perfect, and is often abused, it needs to be reformed and fixed so we can keep getting the benefits without dealing with price fixing and other crap.
Granted, your doc can just prescribe it for the "tested" diagnosis, and use it however they want, but that's a legal gray-area.
Like I said, the system is NOT perfect, and is often abused, it needs to be reformed and fixed so we can keep getting the benefits without dealing with price fixing and other crap.
_________________
Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: Simplus Full Face CPAP Mask with Headgear |
Mike Talon
http://www.miketalon.com
http://www.miketalon.com
- Slartybartfast
- Posts: 1633
- Joined: Wed Sep 01, 2010 12:34 pm
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Back from the grave, or whever it is old threads are reposited?
Interesting. The post TalonNYC answered was from 9/1/2007. I saw the thread when it appeared this morning and wondered what was going on. The most recent activity on that thread was 2007. Don't know how it would suddenly show up in this morning's current topics of discussion.
Wonder if it has anything to do with the tornados ravaging the midwest. . .
Interesting. The post TalonNYC answered was from 9/1/2007. I saw the thread when it appeared this morning and wondered what was going on. The most recent activity on that thread was 2007. Don't know how it would suddenly show up in this morning's current topics of discussion.
Wonder if it has anything to do with the tornados ravaging the midwest. . .
Re: RESMED gone wild - u need prescription to buy RESMED's mask
And then there's the drugs kept off the market because they are "natural" products that can't be patented such as strontium ranelate used in Europe to treat osteoporosis w/very few side effects as compared to the drugs available in the USA such as the bisphosphonates w/ther GI bleed and jaw necrosis risks so aren't financially WORTH developing and approving here in the USA.
And another drug used off-label, low dose Naltrexone for Crohn's disease, deemed not worthy of the expense of FDA approval by the drug companies. Also used for smoking cessation.
Countries such as Germany have government mandated paid vacations of up to 4 - 6 weeks by businesses for their employees. Its not done in the USA since it would cut into the CEO's pay packages which are 2-3 times higher in ratio to their hourly workers than any other country in the world. Paid time off is mandated by law in many parts of the world.
Germany is among more than two dozen industrialized countries -- from Australia to Slovenia to Japan -- that require employers to offer four weeks or more of paid vacation to their workers. Finland, Brazil and France are the champs, guaranteeing six weeks of time off.
And another drug used off-label, low dose Naltrexone for Crohn's disease, deemed not worthy of the expense of FDA approval by the drug companies. Also used for smoking cessation.
Countries such as Germany have government mandated paid vacations of up to 4 - 6 weeks by businesses for their employees. Its not done in the USA since it would cut into the CEO's pay packages which are 2-3 times higher in ratio to their hourly workers than any other country in the world. Paid time off is mandated by law in many parts of the world.
Germany is among more than two dozen industrialized countries -- from Australia to Slovenia to Japan -- that require employers to offer four weeks or more of paid vacation to their workers. Finland, Brazil and France are the champs, guaranteeing six weeks of time off.
_________________
Mask: Quattro™ FX Full Face CPAP Mask with Headgear |
Additional Comments: PR SystemOne BPAP Auto w/Bi-Flex & Humidifier - EncorePro 2.2 Software - Contec CMS-50D+ Oximeter - Respironics EverFlo Q Concentrator |
Women are Angels. And when someone breaks our wings, we simply continue to fly.....on a broomstick. We are flexible like that.
My computer says I need to upgrade my brain to be compatible with its new software.
My computer says I need to upgrade my brain to be compatible with its new software.
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Was just playing with the cpap.com website - looks like scripts are required for complete masks. I think I did an experiment though where I was able to buy all of the piece parts for a Swift FX mask for the same price as complete mask w/ headgear but without a script. I would guess that with the advent of e-businesses like our host, it is possible to get hold of everything you might want without a script.
Of course, that doesn't really answer the question of why you should need a script for masks to begin with.
edit: interestingly, the short hose for the Swift FX is by far the most expensive part of that mask!
Of course, that doesn't really answer the question of why you should need a script for masks to begin with.
edit: interestingly, the short hose for the Swift FX is by far the most expensive part of that mask!
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Mask: Swift™ FX Nasal Pillow CPAP Mask with Headgear |
Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
- billbolton
- Posts: 2264
- Joined: Wed Jun 07, 2006 7:46 pm
- Location: Sydney, Australia
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Most likely a would-be "finest kind" spammer posted something silly on the end as a "test" of their ability to post here and that post was tagged as SPAM by another regular participant, and so disappeared from sight..... but the thread still maintains the recent time stamp so is on the first page for a little while...... where some other regular participant posts to it, and we are then into a zombie thread scenario.Slartybartfast wrote:I saw the thread when it appeared this morning and wondered what was going on. The most recent activity on that thread was 2007. Don't know how it would suddenly show up in this morning's current topics of discussion.
Its best to just leave very old threads alone if they suddenly appear out of nowhere with no evidence of a recent post, no matter what the topic is.
Cheers,
Bill
Re: RESMED gone wild - u need prescription to buy RESMED's mask
Yeah, that was my bad, I didn't look at the OP date.
_________________
Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: Simplus Full Face CPAP Mask with Headgear |
Mike Talon
http://www.miketalon.com
http://www.miketalon.com