Drug Companies begin to outlaw generic substitution

[Caverject]

This is a long read, but well worth reading. This article is about the mfg's of epilepsy drugs trying to change state laws regarding generic substitution before their drugs come out with generic formulations.

http://www.managedcaremag.com/archives/0803/0803.epilepsy.html

It's sort of funny how these "laws" are so well thought out. For example, who is going to pay for the brand name drug when a generic is available? You know the insurance company will make a patient pay thru the nose for something like that. It also forces us pharmacists to do more BS paperwork to actually take care of the patient. Some drug companies that manufacture immunosuppressives are also following a similar tactic.

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[Epic]

That's not the only one.

Astella will sue hospitals if they use generic adenosine for Myocardial Perfusion Imaging. Even though the drug is generic, Asteall owns the patent on Adenoscan in MPI. They will sue you.

 

[Caverject]

has there been any documented cases yet or is it just a threat so far? Astellas is also behind the immunosuppressive tactic since tacrolimus is going generic

 

[SpirivaSunrise]

That's not the only one.

Astella will sue hospitals if they use generic adenosine for Myocardial Perfusion Imaging. Even though the drug is generic, Asteall owns the patent on Adenoscan in MPI. They will sue you.

lol!! How'd you find that one out

 

[Epic]

has there been any documented cases yet or is it just a threat so far? Astellas is also behind the immunosuppressive tactic since tacrolimus is going generic

They sued and won in Miami.. against Boca Raton imaging company.

Un freaking believable.. How can they tell the end user what they can or can't do with the drug they bought.

 

[Epic]

lol!! How'd you find that one out

I know everything.

 

[SpirivaSunrise]

I know everything.

And you didn't believe me...

 

[Epic]

And you didn't believe me...

hmmm.. I don't believe you said anything about the lawsuit..

Still, this is a bogus ruling by an idiot judge in FL... They can not enforce this rule to the end user... they can enforce this to companies marketing it.

This patent expires this December...with 159 day extension. We shouldn't have issues with this after next year.

But we'll remember Astella for the decision they made to start suing their customers or threatening a lawsuit against their own customers.

 

[SpirivaSunrise]

hmmm.. I don't believe you said anything about the lawsuit..

Still, this is a bogus ruling by an idiot judge in FL... They can not enforce this rule to the end user... they can enforce this to companies marketing it.

This patent expires this December...with 159 day extension. We shouldn't have issues with this after next year.

But we'll remember Astella for the decision they made to start suing their customers or threatening a lawsuit against their own customers.

No...I wasn't aware of the lawsuit. But I did say we couldn't supply generic because of AdenoScan's MPI indication with Tl-201.

Ludicrious though. Wonder if that ruling would even stand if it was challenged...

 

[MountainPharmD]

Is there any doubt as to what the biggest problem in healthcare is today? I vote drug companies....

 

[Caverject]

Insurance companies are a close second...

 

[SpirivaSunrise]

Astella will sue hospitals if they use generic adenosine for Myocardial Perfusion Imaging. Even though the drug is generic, Asteall owns the patent on Adenoscan in MPI. They will sue you.

Oh boy... ‘next generation’ stress agent by Astellas

 

[FruitFly]

Pharmaceutical turf wars... bleh... the patients always get caught in the crossfire...

 

[YapYap6]

In a perfect world, the government would inject the billions we're spending in Iraq into university level drug research. No more pharmaceutical companies and the profits from this research would go towards free tuition for all college students! YAY!


Wishful thinking.

 

[Knipps]

In a perfect world, the government would inject the billions we're spending in Iraq into university level drug research. No more pharmaceutical companies and the profits from this research would go towards free tuition for all college students! YAY!


Wishful thinking.

and then it gets even tougher to get into pharmacy school, with fewer spots open and a greater deficit of pharmacists

 

[AggiePharmer]

In a perfect world, the government would inject the billions we're spending in Iraq into university level drug research. No more pharmaceutical companies and the profits from this research would go towards free tuition for all college students! YAY!


Wishful thinking.

eh, my 2 cents:

I'm all for reforming education and basic healthcare options, but considering that around 20% of the human genome's already patented and the industry's built around innovation through financial profits (on recent drugs), isn't this kind of old news?

 

[meister]

Well phenytoin, levothyroxine and bupropion are actually three medications where I don't really blink twice when a patient or physician demands brand name. If you're stable on brand name Dilantin, why in the hell would you want to switch to the generic and risk passing out while driving on the freeway? As a corollary, if you're stable on phenytoin, why would you want to risk anything by switching back to the brand name?

 

[PharmDstudent]

Well phenytoin, levothyroxine and bupropion are actually three medications where I don't really blink twice when a patient or physician demands brand name. If you're stable on brand name Dilantin, why in the hell would you want to switch to the generic and risk passing out while driving on the freeway? As a corollary, if you're stable on phenytoin, why would you want to risk anything by switching back to the brand name?

I believe the Dilantin liquid was D/Ced. We had a patient who was stable on the brand name liquid. For all I know, I think he's fine. I wish I could remember what they switched him to.

 

[YapYap6]

eh, my 2 cents:

I'm all for reforming education and basic healthcare options, but considering that around 20% of the human genome's already patented and the industry's built around innovation through financial profits (on recent drugs), isn't this kind of old news?

Most universities are driven by profits as well. Most innovations in technology and science are driven by universities already; however, drug research seems to be much more difficult and much costlier hence extra government funding channeled to the right programs would be a good way to encourage drug research. Universities that come up with novel drugs would get patents and the resulting profitttssssssssssss from their sales. Imagine if universities made the same profits from their work as the major drug companies. We'd all have full ride scholarships!

Old news? I guess it is. But hey, why not beat the donkey's nuts a bit more?

 

[njac]

epic et al - does anyone have a link to the specifics on the adenoscan case?

I mentioned it in class and got a bunch of snickering and blank stares, but a quick search didn't yield anything useful.

 

[YapYap6]

and then it gets even tougher to get into pharmacy school, with fewer spots open and a greater deficit of pharmacists

Then our salaries would go up even more and we'd make more profittttsssssssss.

 

[SpirivaSunrise]

njac~

From the et al side (aka the peanut gallery...) I wasn't aware of the lawsuit, but was curious myself why more of our customers didn't use generic, since we supply a lot of Adenoscan (including unit dose which we make up for them). I figured it had to do with the fact that Astellas had the indication though. So I could see why we couldn't supply it...but why wouldn't a hospital/clinic obtain the generic themselves? (Other than to avoid the hassle of drawing up from multiple vials...which would be silly based on savings alone).

I mentioned the lawsuit to a few of the other pharmacists in passing and they were aware of similar ones...not that one in particular though. If I had to take a guess, I have a feeling the sticking point in that case had to do with the way that clinic was billing. Otherwise...off-label use occurs all the time. How the defendant wouldn't be able to demonstrate that, I'm not sure...

(Sheesh, that took a while to type up on a pocket pc @ the airport )

 

[Priapism321]

Well phenytoin, levothyroxine and bupropion are actually three medications where I don't really blink twice when a patient or physician demands brand name. If you're stable on brand name Dilantin, why in the hell would you want to switch to the generic and risk passing out while driving on the freeway? As a corollary, if you're stable on phenytoin, why would you want to risk anything by switching back to the brand name?

I would then ask you to provide me with some objective scientific data that proves any of the events you state may occur are actual risks of switching between formulations of AB rated drugs. If the FDA's rules on bioequivalence are too liberal to the point you think patients may actually be harmed, you should be petitioning the FDA to change their rules.

Likewise, could you prove that the lot to lot variability of name brand phenytoin/levothyroxine/etc./etc. does not pose similar risks that you describe above?

And no, objective, scientific evidence is not a news story about some whack job who was probably never stable in the first place complaining that her "genetic (mispelled intentionally) Wellbutrin doesn't work."

 

[Farmercyst]

epic et al - does anyone have a link to the specifics on the adenoscan case?

I mentioned it in class and got a bunch of snickering and blank stares, but a quick search didn't yield anything useful.

Epic could probably confirm, but I think this is it.
http://www.patentdocs.net/patent_docs/files/astellas_v_anazaohealth.pdf

 

[SpirivaSunrise]

Epic could probably confirm, but I think this is it.
http://www.patentdocs.net/patent_docs/files/astellas_v_anazaohealth.pdf

Hmmm...I don't think that's it. From what I gathered after skimming through that one...what NuView/Anazao was doing there is pretty shady.

 

[Jitaka]

eh, my 2 cents:

... but considering that around 20% of the human genome's already patented...

Is this a true statement? I can't believe that an entity, or a group of wealthy and influential persons, can actually legally own bits and pieces of nucleic acids. Crazy.

 

[b*rizzle]

eh, my 2 cents:

I'm all for reforming education and basic healthcare options, but considering that around 20% of the human genome's already patented and the industry's built around innovation through financial profits (on recent drugs), isn't this kind of old news?

Soon you'll have to start paying royalties when you visit the Red Cross to donate blood...


AWWW Mountain, but don't you want your free drug pens, note pads, counting trays, coasters, ZIP drives, coasters, name badge clips, and catered dinners? Target actually made us get rid of all the contraband.

 

[AggiePharmer]

Is this a true statement? I can't believe that an entity, or a group of wealthy and influential persons, can actually legally own bits and pieces of nucleic acids.

Hmm, please forgive me that I currently don't have access to my Nature op-ed articles but I do have this:

http://www.genome.gov/19016590

General jist is that yea, a significant amount of the genome has been patented (and that's probably a conservative figure) by both academia and industry. Yes, there have been a few anecdotal instances where genetic patents have infringed upon intellectual property rights for developing drugs, but the general consensus according to the Managing Director for Cooperative Research at Yale, Dr. Soderstrom, is that genetic patents "are not typically used to restrict access to knowledge and tangible materials that biomedical scientists require." Hence, although the possibility for mistrust and litigation exists as a result of infringing upon corporate genetic patents, academic research and NIH drug discovery have remained relatively shielded to date.

Of course, feel free to read more from this 129pg behemoth, here:

http://judiciary.house.gov/media/pdfs/printers/110th/38639.pdf

I'll defer to more knowledgable people with joint JD/PharmD's as to how this all applies to the generic distribution of drugs (once their patents expire), but thinking about this tonight has given me a headache.