The Hatch-Waxman Act (ie. the Drug Price Competition & Patent Term Restoration Act) was designed to give generic drug manufacturers strong incentives to develop lower-cost generics to save you, the consumer, mucho dinero. The main perk for GenCo is 180 days of exclusive generic marketing if the generic can be produced in a way that is non-infringing to BrandCo's magical production process or if GenCo has a valid challenge to the patent upon which BrandCo's drug relied.
Big money, no whammies, stop! Stopped on a whammie. BrandCo filed a patent infringement action within 45 days of my GenCo patent application for a sweet sweet patented generic deal that would give me exclucive rights for up to 3 years (Patented generics are the new black, or is it the new pink that was the new black, can I get a wah wah-Budeprion/Buproban).
Now, watch them pull a rabbit out of their hat! The Uruguay Round Agreements Act of 1994 (URAA) changed the length of patent for ALL inventions from 17 years post patent grant date to 20 years from the date of patent application. I smell a lobbyist, I mean a rat because this includes ALL BrandCo drug patents that did not expire prior to 1994. So now BrandCo not only gets a 3+ year patent extension they also still qualify for an additional letigious patent extension via Hatch-Waxman.
I strike back at BrandCo with the Medicare Prescription Drug Improvement and Modernization Act that limits their letigious choke-hold on my ANDA to ONE 30-month stay against marketing the generic. I will be sitting pretty if my generic comes to market, but wait, somewhere a "concerned" citizen has filed a petition to prevent my generic from being approved. I smell a rat, I mean a lobbyist or other BrandCo supporter because ALL issues in this "concern for public safety" petition must be resolved before I can market my generic. Shenanigans!
After all of these thorns in my side, I produce my generic. Only one problem.....there was a declaratory judgement which resulted in NO assurance that my generic is not in violation of the brand-name patent. This means that I can produce and sell my generic but BrandCo may sue for patent infringement at any moment.
You sank my battleship!
Wednesday, May 16, 2007
Degree of Uncertainty
Have you ever seen the commercials for Degree antiperspirant/deodorant? They make some pretty fantastic claims: no marks on black clothing, superior wetness protection and odor control that works better the more you sweat, and odor control. Was the test group a bunch of "chain smokers?" I used the women's version of this product for a week and was horrified that I would have to change my name to Big 'N Stinky if this was the best deodorant/antiperspirant available. I ran this by a colleague who also tried the men's version of this "deodorant." He thought the smell was just him. So rather than isolate myself by being inflagrante de-stinko I went back to my regular deodorant and now people like me again! Note to corporate America: if your product says "deodorant" on it, then it should be a deodorant instead of making you smell like the dirty towel receptacle at a gym!
Monday, April 30, 2007
Shame Shame Drug Game Part 1
Ah yes, the ultra-lucrative drug business. "Big pharma" and the third party healthcare providers have made an artform of keeping prices up. If I had a dollar for every time someone yelled at me about drug prices I would be richer than Bill Gates and Steve Jobs combined. I have no control over the prices. I am just a worker bee helping you to not kill yourself by taking the wrong med(s) and giving the wrong med(s) or doses to your precious little children (or your pet I am compounding for). I stick to the medical and sympathize with the price points. Perhaps if you paid with a "rewards" credit card and pay the bill off when it comes in at least you could get some enjoyment out of life...
The first game drug companies like to play is "We have this mega-great super-fantastic drug that is better than the one we put out 13 years ago!" So you made a slight change to drug "acid blocker" and duplicated the tests with "better" results and came up with the same side effect and drug interaction profiles. Not to mention that the "acid blocker" is going generic and OTC at about the same time and you stand to lose mucho dinero. So you use doctor prescribing incentives and "free" samples to get "mega acid blocker" on every prescription pad in the world. Don't forget contract pricing with third party insurance providers so you can screw the pharmacies that have to supply the public with "mega acid blocker" and try to pretend that the public will be healthier with a $50 copay when the generic OTC works just fine for 98% of patients at one-fourth of the price.
Another fun game is "This works better in extended release." Usually 12 to 14 years into the product life an extended release version is patented, approved and marketed. "Sleepy Time" has activity in the human body for 6 to 8 hours. The patent expiration date is coming up so we made "Sleepy Time CR." Not only are you sleeping longer but the "hangover" sure makes that morning commute fun! Did we really need "Sleepy Time CR?" Nope! For that matter you probably don't want to be on anything that makes you dependent on it to sleep.....the ace in the hole...once you start taking "Sleepy Time" you will always need to take "Sleepy Time." Oh no, now that "Sleepy Time" is available in the generic formulation maybe patients will lose interest in your new formula in order to save a significant amount of money on copays and avoid the messy "prior authorization" process to get the "Sleepy Time" in any form in the first place.
I know, you believe in the FDA. I used to until crap like this started happening. We need serious changes to the drug patent laws. The typical drug patent gives exclusive manufacturing rights to a drug for 17 years. I think that non-innovator drugs such as extended release or "altered and improved" products should only be given a patent of 5 years. With all the tax breaks the government gives there should not be any incentive to "beat the system to death with a stick" in order to make a fast buck.
The first game drug companies like to play is "We have this mega-great super-fantastic drug that is better than the one we put out 13 years ago!" So you made a slight change to drug "acid blocker" and duplicated the tests with "better" results and came up with the same side effect and drug interaction profiles. Not to mention that the "acid blocker" is going generic and OTC at about the same time and you stand to lose mucho dinero. So you use doctor prescribing incentives and "free" samples to get "mega acid blocker" on every prescription pad in the world. Don't forget contract pricing with third party insurance providers so you can screw the pharmacies that have to supply the public with "mega acid blocker" and try to pretend that the public will be healthier with a $50 copay when the generic OTC works just fine for 98% of patients at one-fourth of the price.
Another fun game is "This works better in extended release." Usually 12 to 14 years into the product life an extended release version is patented, approved and marketed. "Sleepy Time" has activity in the human body for 6 to 8 hours. The patent expiration date is coming up so we made "Sleepy Time CR." Not only are you sleeping longer but the "hangover" sure makes that morning commute fun! Did we really need "Sleepy Time CR?" Nope! For that matter you probably don't want to be on anything that makes you dependent on it to sleep.....the ace in the hole...once you start taking "Sleepy Time" you will always need to take "Sleepy Time." Oh no, now that "Sleepy Time" is available in the generic formulation maybe patients will lose interest in your new formula in order to save a significant amount of money on copays and avoid the messy "prior authorization" process to get the "Sleepy Time" in any form in the first place.
I know, you believe in the FDA. I used to until crap like this started happening. We need serious changes to the drug patent laws. The typical drug patent gives exclusive manufacturing rights to a drug for 17 years. I think that non-innovator drugs such as extended release or "altered and improved" products should only be given a patent of 5 years. With all the tax breaks the government gives there should not be any incentive to "beat the system to death with a stick" in order to make a fast buck.
Sunday, April 29, 2007
Weakend
Oh how I love working the weekend. There's nothing quite like it. Here's a few examples that contribute to the slow demolition of my soul. The typical weekend shift starts out like this...I walk back to my cage, only to be greeted by at least two customers standing and staring at the closed pharmacy. Their eyes aglow and filled with a childlike anticipation, knowing that their vicodin is just on the other side of that closed gate. Here's the deal folks; you want to walk around the main store until the pharmacy OPENS and then come back and throw your prescription at me. This will make me hate you less and make your wait time only 30 minutes instead of the 45 i was planning to go with.
Sometime later that day, I'll get the call that makes me want to impale myself on the nearest pill counter. The person who wants me to transfer their prescriptions from another store. I have to take at least three deep breaths before I even say anything to you. There is nothing I hate more than having to call other pharmacies on the weekend because you are too lazy to get off your ass and go there before they close. Can I ask you something? How was obtaining the inhaler that you need to breath not priority one on your list for the day? "Well...let's see...big day ahead of me today, that's for sure...first, I figure I'll watch tv for about 4 hours, then I have to remember to slam my thumb in the car door so I can keep my workman's comp claim open...hmmm, what else...oh yeah, definitely watch some more tv, and then I guess if I have time I'll go pick up that inhaler that keeps me from dying." Awesome.
This leads us to my favorite part of the day: The last minute throng of regular customers who show up right before we close. We have been open for NINE hours people, and I know that you are fully aware. Where the hell have you been? It's really the perfect metaphor for your lives. Please don't wait until the last minute to do important things and then act like a child when you are once again confronted with the fact that the world does not revolve around you. You are not the Sun. I am not the Earth. In reality, you are on your own planet, where time does not exist and vicodin is the Sun. Look out for asteroids.
Sometime later that day, I'll get the call that makes me want to impale myself on the nearest pill counter. The person who wants me to transfer their prescriptions from another store. I have to take at least three deep breaths before I even say anything to you. There is nothing I hate more than having to call other pharmacies on the weekend because you are too lazy to get off your ass and go there before they close. Can I ask you something? How was obtaining the inhaler that you need to breath not priority one on your list for the day? "Well...let's see...big day ahead of me today, that's for sure...first, I figure I'll watch tv for about 4 hours, then I have to remember to slam my thumb in the car door so I can keep my workman's comp claim open...hmmm, what else...oh yeah, definitely watch some more tv, and then I guess if I have time I'll go pick up that inhaler that keeps me from dying." Awesome.
This leads us to my favorite part of the day: The last minute throng of regular customers who show up right before we close. We have been open for NINE hours people, and I know that you are fully aware. Where the hell have you been? It's really the perfect metaphor for your lives. Please don't wait until the last minute to do important things and then act like a child when you are once again confronted with the fact that the world does not revolve around you. You are not the Sun. I am not the Earth. In reality, you are on your own planet, where time does not exist and vicodin is the Sun. Look out for asteroids.
Friday, April 27, 2007
Thanks For Nothing
Customer: "Do you have boric acid?"
Me: "No, I'm sorry, we don't carry that"
Customer: "Well, I think my gerbil has an eye infection. What do you have for that?"
Me: "You know, honestly, I'm really not sure. I'm not trained in gerbil medicine. I would suggest calling a veterinarian"
Customer: "Well thanks for nothing!" (followed by her storming off down aisle 8)
Really? Thanks for nothing? I informed you about our current inventory status, gave an honest answer about my lack of expertise and then offered you guidance on where to go for the best advice. This is why on some level I hate 60 to 70 percent of my customers. I am polite, friendly and helpful and yet you still treat me like i just gave you cancer. I mean seriously, it's a gerbil. I don't know anything about gerbils. If I had a gerbil and it got an eye infection I would think to myself 'Well, it had a good run...I guess if this doesn't clear up on it's own, I'll just buy a mini gerbil eye patch and change his name to Blackbeard' (on an ironic side note, famed pirates Blackbeard and William Kidd once waged a fierce sea battle in an effort to finally settle their long running debate over the virtues of gerbils vs. hamsters). But i digress. The point is, don't go to the pharmacy, get free advice, and then get pissed when that advice isn't what you wanted to hear. Grow up. Act like an adult. Seriously. It's like going to Jiffy Lube and asking how to fix the engine on your lawn mower. Here's a crazy idea, maybe you should just call the store you bought it from. Also, if I could just make another suggestion to customers, don't come in, lift up your shirt to expose your stomach and ask "Is this scabies?". It's only going to make me lift up my shirt and ask "Is this my soul being slowly torn apart?" I'm not a doctor, I'm not a veterinarian, and I'm not a gerbil hater. I'm a pharmacist. Thanks for nothing.
Me: "No, I'm sorry, we don't carry that"
Customer: "Well, I think my gerbil has an eye infection. What do you have for that?"
Me: "You know, honestly, I'm really not sure. I'm not trained in gerbil medicine. I would suggest calling a veterinarian"
Customer: "Well thanks for nothing!" (followed by her storming off down aisle 8)
Really? Thanks for nothing? I informed you about our current inventory status, gave an honest answer about my lack of expertise and then offered you guidance on where to go for the best advice. This is why on some level I hate 60 to 70 percent of my customers. I am polite, friendly and helpful and yet you still treat me like i just gave you cancer. I mean seriously, it's a gerbil. I don't know anything about gerbils. If I had a gerbil and it got an eye infection I would think to myself 'Well, it had a good run...I guess if this doesn't clear up on it's own, I'll just buy a mini gerbil eye patch and change his name to Blackbeard' (on an ironic side note, famed pirates Blackbeard and William Kidd once waged a fierce sea battle in an effort to finally settle their long running debate over the virtues of gerbils vs. hamsters). But i digress. The point is, don't go to the pharmacy, get free advice, and then get pissed when that advice isn't what you wanted to hear. Grow up. Act like an adult. Seriously. It's like going to Jiffy Lube and asking how to fix the engine on your lawn mower. Here's a crazy idea, maybe you should just call the store you bought it from. Also, if I could just make another suggestion to customers, don't come in, lift up your shirt to expose your stomach and ask "Is this scabies?". It's only going to make me lift up my shirt and ask "Is this my soul being slowly torn apart?" I'm not a doctor, I'm not a veterinarian, and I'm not a gerbil hater. I'm a pharmacist. Thanks for nothing.
Saturday, April 21, 2007
Poppin' Fresh
Thursday overnight shifts tend to be chock full of boredom. This past Thursday started out the same but took a turn for the amusing.
An elderly gentleman we refer to as "Old Pop" pushed his cartload of belongings back to the pharmacy and sat down in the massage chair where he fell alseep. I kept doing my paperwork because he comes in on a semi-regular basis to buy chips and use the massage chair. No worries.
About an hour later my store manager came to the drop-off window laughing hysterically. He was like "Did you look over there?" I told him I knew "Old Pop" was there and had been there sleeping for about an hour. He said "look again." So I went over and took a closer look.
Holy Elephantitis, Batman!
His family jewels were poppin' fresh out of his "Daisy Dukes!" I had a good laugh but am glad no customers saw him. The manager woke him up to "make an adjustment" and send him on his way. I hope he wears pants next visit!
An elderly gentleman we refer to as "Old Pop" pushed his cartload of belongings back to the pharmacy and sat down in the massage chair where he fell alseep. I kept doing my paperwork because he comes in on a semi-regular basis to buy chips and use the massage chair. No worries.
About an hour later my store manager came to the drop-off window laughing hysterically. He was like "Did you look over there?" I told him I knew "Old Pop" was there and had been there sleeping for about an hour. He said "look again." So I went over and took a closer look.
Holy Elephantitis, Batman!
His family jewels were poppin' fresh out of his "Daisy Dukes!" I had a good laugh but am glad no customers saw him. The manager woke him up to "make an adjustment" and send him on his way. I hope he wears pants next visit!
Wednesday, April 18, 2007
Customer Complaint
So, I had a customer complain about me today to my store manager. According to her every time she comes in I look at her like I'm better than her and I "look down on her". First of all, don't go to my store manager to complain about me. They don't care and you are only giving us something to laugh about after you leave. On second thought, complain all you like. Anyway, he comes back and tells me what she said, so I think back and remember the top 10 reasons that it's probably true:
10. She's on state medicaid and she's a frequent flyer on Vicodin Airlines
9. She has 3 kids with 3 different last names
8. She once bought cigarettes and had to "come back later" because she didn't have 2 dollars left for her son's inhaler
7. She never came back
6. She once interrupted me when I was counseling someone to ask me "where the condoms where at"
5. She didn't say thank you and she apparently never used the condoms
4. She smokes when she has the three kids in the car with her and "doesn't need no counseling" because her kids have had the bronchitis antibiotics "tons of times"
3: She once asked me why the doctor would write for something if it wasn't covered, because she "doesn't pay for shit"
2: She said this in front of her three kids (the oldest being 7)
1. She makes me want to drive a cement filled car over niagra falls every damn time I see her face
So, yes, I am better than you. And yes, I will proudly display it every time you come in my store. Have a great day
10. She's on state medicaid and she's a frequent flyer on Vicodin Airlines
9. She has 3 kids with 3 different last names
8. She once bought cigarettes and had to "come back later" because she didn't have 2 dollars left for her son's inhaler
7. She never came back
6. She once interrupted me when I was counseling someone to ask me "where the condoms where at"
5. She didn't say thank you and she apparently never used the condoms
4. She smokes when she has the three kids in the car with her and "doesn't need no counseling" because her kids have had the bronchitis antibiotics "tons of times"
3: She once asked me why the doctor would write for something if it wasn't covered, because she "doesn't pay for shit"
2: She said this in front of her three kids (the oldest being 7)
1. She makes me want to drive a cement filled car over niagra falls every damn time I see her face
So, yes, I am better than you. And yes, I will proudly display it every time you come in my store. Have a great day
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