"I don't understand the outcry from doing what you're supposed to do by law and then allowing someone to manufacture a drug by filing some paperwork which makes it so they don't have to proceed with a myriad of tests and pay smaller filing fees."
There's nothing wrong at all with ANDAs. They are a good thing.
The outcry is all about government regulators gift-wrapping and delivering a monopoly to a single company.
Read my comment in the other post about Makena this week that explains how this happens.
Plain and simple, Monopolies are BAD. Normal market forces don't have the opportunity to work.
If you want to play the "safety card" and say the FDA is just protecting us from unsafe drugs, I argue 2 points in return:
1) These were old drugs with a track-record lasting decades. Little or no evidence of danger had arisen in that period
2) Monopoly is itself a safety issue, because if you can't afford a treatment like Makena that now costs $30,000, then your unborn child dies.
To get the exact answer to that, you would have to ask someone who was in management of Bristol Meyers Squibb in 1999.
However, what is known, is that BMS asked the FDA to rescind approval for the drug.
A reasonable guess would be that since BMS had decided that they would no longer market it [ probably because of lawsuits + low market volume], that they wanted to impair any other company from using the approval Squibb had obtained years before to bring it back to market. Perhaps this was a bit of preemptive restraint of the generic manufacturing companies who the "big-pharma" corporations have frequently sparred with over the years.
You can read more about it Here.
"In your wild west we would degrade to selling products which are entirely safe, and could be marketed the best, not which compounds are shown to be safe and shown to work through scientific study."
The point of this article today is that most of the FDA action is NOT a case of "taming the wild west".
Many of the drugs which the FDA have removed had no history of problems after having been marketed for decades. Now if you are suspicious, you can believe that maybe connections between regulators and industry provoked these actions, but more likely its a matter of bureaucrats being bureaucrats and wanting to make manufacturers meet current standards, rather than the standards which were in place when the drugs first came to market.
A few days ago the drug Delalutin = Makena was discussed on Techdirt, and I laid out what had gone wrong with the market in that situation. The sky-high prices with Makena didn't come about because of patents. The issue is exactly what is being discussed in this post --> Regulatory activity delivering a Monopoly to a manufacturer. Since I posted so late on that article, it missed the reading cycle so if you didn't see it, the explanation of what happened with Makena can be read here.
"In the real world, freedom is tempered by balance between the rights of each individual towards each other, and also towards the state."
Ok, I understand that there will always be valued goals which come into conflict with one another, and that judgments must be made as to where to pursue one goal at the expense of another.
I'd like to point out however that if you are going to make the rational risk assessment, then you do not have a winning argument. The number of terrorist attacks and the number of lives lost is minuscule compared to a host of other risks we face every day.
It's not logical when you consider the cost -- both in dollars, and also in lost civil liberties.
As was pointed out elsewhere in today's discussion, I don't want to be a victim of someone else's illogical fears.
As a taxpayer, I don't want the TSA to be adding billions annually to the federal deficit, and as a citizen, I don't want to be subjected to intrusive searches, and most importantly, I don't like the precedent that is being set, wherein the government thinks it is standard operating procedure to use intrusive searches on law-abiding citizens anytime there is a remote risk.
This precedent is dangerous because it delivers to the government precisely the powers needed to establish a totalitarian regime at some point in the future. I'm not way out there arguing that Obama is the next Stalin or Hitler.
I'm arguing that what is being done now will make it harder to resist should someone with those aspirations appear in the future.
To return to my first point in the post above -- what I said about dictators is exactly true. They have ALL insisted that what they were doing was essential to protect the safety of their country.
It is dangerous to unquestioningly accept that the government always knows best because the government is looking out for your own safety.
Our countries founding fathers had principles for a reason. The reason is that they were very familiar with the governmental abuses that had gone on in England and elsewhere in the 150 years the preceded the American Revolution. They were determined to create a system that would be resistant to the failures of the 17th century.
Let's not sacrifice those principles for a little better safety and short-term risk reduction.
"I'd rather choose to not be a victim of other people's fears. "
Yes --- Outstanding line!!!
The supporters of the unconstitutional onslaught are either Cowards or else they are slimeballs with ulterior motives (relating to personal profit or personal power).
"the legitimate government interest is ... the safety of it's citizens..."
Are you so damn ignorant that you don't know that this it the fundamental lying argument that every single demagogue, totalitarian, and dictator of any stripe -- be it communist, fascist, divine right absolutist, or good old fashioned despot, has used since the dawn of time to try to justify abusive treatment of their citizens, and preserve the level of obedience needed to maintain power.
If you don't know this, then many quotes from history can be given to you. But, then if I gave some of them to you now, you'd go all Godwin on me.
What you lack is any sense that the principles of freedom upon which our country is supposed to stand are of absolute prime importance. Those who love freedom judge that freedom is worth taking risk. If that were not so, then our country never would have come to be. Despots on the other hand are inwardly cowards.
If freedom doesn't concern you, and all you care about it order and maintaining authority, then one doesn't need to guess very hard on whose side you would have stood in 1776.
As an aside, I suspect the only reason you are here commenting on Techdirt is to make sure that 4th amendment rabble-rousers don't rain on your COICA parade.
Next up, MS is going to sue over the ability to...breathe
MG Siegler has more withering criticism of Microsoft's lawsuit over at TechCrunch.
Its all about trying to use patent licensing to take some of the profit from someone else's product by making ridiculous claims of innovation where clearly Microsoft didn't invent anything.
To quote Siegler: "Next up, Microsoft is going to sue over the ability to type, look, and maybe even breathe."
The Makena situation is complicated, and it is a good illustration of unintended consequences of government regulation. If also demonstrates the consequences of lawsuits on the marketplace.
Despite the content of many comments here today, what this story DOES NOT involve is patents or research and development.
Rather what this story does show is how government intervention in the marketplace can produce an effective monopoly, even without a patent or other IP law at play.
Here are the facts:
--> Delalutin = Makena = hydroxyprogesterone
1) 1956: Delalutin is approved by the FDA for treatment of abnormal uterine bleeding.
2) 1970: FDA approves additional indication for treatment of uterine cancer.
3) 1973: Bristol Meyers Squibb requests approval for an indication to treat threatened miscarriage (The indication for which 'Makena' is now being marketed). The FDA denies this request, saying that there is too much risk of birth defects. This usage of Delalutin continues however as physicians prescribe it "off-label".
4) After patent expiration, multiple manufacturers produce/market hydroxyprogesterone in the US.
5) 1977, 1978: The FDA requires additional labeling warnings on Delalutin regarding birth-defects.
6) After the warnings are published, lawsuits blaming Delalutin for birth defects occur during the 1980's, prompting some manufacturers to withdraw from the market.
7) 1999: The FDA decides that further scientific evidence does not support the worries about birth defect risks, and the requirement for warnings against using the drugs in pregnant women are removed -- [but it's too late.]
8) 1999: Bristol, Meyers Squibb, the last remaining manufacturer, notifies the FDA without explanation that they had stopped supplying Delalutin several years earlier. [One may assume that BMS took this action because it was a low volume drug with low profit versus its legal liability.]
10) 1990's - 2006: Certain small companies in the "compounding pharmacy" business continue to supply hydroxyprogesterone to physicians who continue to use it off-label to suppress miscarriage.
11) 2006: The FDA begins a new safety initiative to remove unapproved or untested drugs from the marketplace. The FDA begins forcing compounding pharmacies to stop making hydroxyprogesterone ***[ This event in effect removes all competition from the marketplace. It sets up a situation where the first company to return to the market after having done the testing required by the FDA will have a complete monopoly -- and surprise! Thats exactly what happened. ]
12) Feb 2011: FDA approves Makena for treatment of threatened preterm birth. [Their pharmaco-economists decide that the market will bear a very steep price of 30,000 for a full treatment course. Given that this is in the same price ball-park as in-vitro fertilization procedures, and given that there's NO COMPETITION, what is to stop them?]
13) Mar 2011: Senators call for hearings so they can rant about about price gouging.
--> What they should be looking at is how government regulation (step # 11) has resulted in loss of competition. If Congress had real leadership, or if executive branch regulators cared, the focus of the discussion would be : --> How to preserve both safety and competition. For now however, encouraging competition remains an afterthought at best.
This should be Adam Smith 101, but so many people don't seem to understand so let me say it a few times: Competition, Competition, Competition!!
Unfortunately the 4th Amendment is that portion of the Constitution for which all three branches of government have long shown the least respect. A current paper by Orin Kerr, which will be published in an upcoming issue of the Harvard Law Review calls 4th Amendment Law "a theoretical embarrassment".
"Don't you know? Haven't you been reading TechDirt? The solution to making IP respectable is to abolish IP!"
Cut the bullshit.
There are a few abolitionists around here, but most regulars are not abolitionists. You will be hard pressed to come up with very many posts advocating that. What you will find is a lot of people who think the principle of fairness has left IP law and IP enforcement a long time ago. The current laws are neither reasonable, nor do they promote progress and productivity. They do protect the income of a very small group of people. This group rarely includes the actual creative individuals, but instead is mostly "suits". Meanwhile a barrage of disinformation and lobbying continues in an attempt to maintain the status quo.
"And please, don't confuse my interest in the legal arguments with my opinions about the policy arguments. They're two distinct things."
Hmm. Based on all you've said here in recent months, that's an interesting comment. I guess we'll see if you actually make any distinction between the logical basis for policy and the specific legal arguments needed to support that policy.
Jeez, why doesn't Krawczynski just call that innovative attorney John Steele so he can start one of those new-fangled reverse class-action lawsuits against the whole stadium who booed him.
You've had so many rebuttal arguments directed your way, but you remain unconvinced. Depending on where a person stands, that either says a lot about you, or it says a lot about the quality of arguments. Suffice it to say however, there is not likely to be any rebuttal that will satisfy you because you already have cemented your opinions.
AJ, you are passing judgement about whether it's grandstanding based on whether you agree with what is being said.
A person can be exactly correct in everything they say and still be grandstanding, so it's not the content of what is said, but the manner and purpose of the statements.
Morton is calling press conferences and making public statements, the facts of which may or may not be true, but an additional political message being transmitted is the following: 'Here's how we're attacking crime. See what a good job we are doing. Here's how valuable we are.'
In a government administrative job, this kind of behavior is good for your resume. It's good for your budget; and incidentally - it's good for campaign contributions to the guy who appointed you. That's grandstanding.
Now think about the definition of grandstanding. If you insist on stating that Lofgren is grandstanding, but you can't admit that Morton is doing it then I call BS. That's as good as admitting you have a bias.
On the post: FDA Suddenly Bans Drugs That Have Been On The Market For Decades
Re: Re:
The article is not about the development of new drugs. It's about restraining competition to manufacture and distribute OLD drugs.
On the post: FDA Suddenly Bans Drugs That Have Been On The Market For Decades
Re: Re: Re: Re: Re: Re: Re: And!
The outcry is all about government regulators gift-wrapping and delivering a monopoly to a single company.
Read my comment in the other post about Makena this week that explains how this happens.
Plain and simple, Monopolies are BAD. Normal market forces don't have the opportunity to work.
If you want to play the "safety card" and say the FDA is just protecting us from unsafe drugs, I argue 2 points in return:
1) These were old drugs with a track-record lasting decades. Little or no evidence of danger had arisen in that period
2) Monopoly is itself a safety issue, because if you can't afford a treatment like Makena that now costs $30,000, then your unborn child dies.
On the post: FDA Suddenly Bans Drugs That Have Been On The Market For Decades
Re: Re: Re: Re: Re: And!
However, what is known, is that BMS asked the FDA to rescind approval for the drug.
A reasonable guess would be that since BMS had decided that they would no longer market it [ probably because of lawsuits + low market volume], that they wanted to impair any other company from using the approval Squibb had obtained years before to bring it back to market. Perhaps this was a bit of preemptive restraint of the generic manufacturing companies who the "big-pharma" corporations have frequently sparred with over the years.
You can read more about it Here.
On the post: NY Times In Denial: Only Teens & The Unemployed Will Game The Paywall
Re: Wow
On the post: FDA Suddenly Bans Drugs That Have Been On The Market For Decades
Re: Re: Re: And!
Many of the drugs which the FDA have removed had no history of problems after having been marketed for decades. Now if you are suspicious, you can believe that maybe connections between regulators and industry provoked these actions, but more likely its a matter of bureaucrats being bureaucrats and wanting to make manufacturers meet current standards, rather than the standards which were in place when the drugs first came to market.
A few days ago the drug Delalutin = Makena was discussed on Techdirt, and I laid out what had gone wrong with the market in that situation. The sky-high prices with Makena didn't come about because of patents. The issue is exactly what is being discussed in this post --> Regulatory activity delivering a Monopoly to a manufacturer. Since I posted so late on that article, it missed the reading cycle so if you didn't see it, the explanation of what happened with Makena can be read here.
On the post: Homeland Security Says They Could Strip Search Every Airline Passenger If They Wanted To
Re: Re: Re:
I'd like to point out however that if you are going to make the rational risk assessment, then you do not have a winning argument. The number of terrorist attacks and the number of lives lost is minuscule compared to a host of other risks we face every day.
It's not logical when you consider the cost -- both in dollars, and also in lost civil liberties.
As was pointed out elsewhere in today's discussion, I don't want to be a victim of someone else's illogical fears.
As a taxpayer, I don't want the TSA to be adding billions annually to the federal deficit, and as a citizen, I don't want to be subjected to intrusive searches, and most importantly, I don't like the precedent that is being set, wherein the government thinks it is standard operating procedure to use intrusive searches on law-abiding citizens anytime there is a remote risk.
This precedent is dangerous because it delivers to the government precisely the powers needed to establish a totalitarian regime at some point in the future. I'm not way out there arguing that Obama is the next Stalin or Hitler.
I'm arguing that what is being done now will make it harder to resist should someone with those aspirations appear in the future.
To return to my first point in the post above -- what I said about dictators is exactly true. They have ALL insisted that what they were doing was essential to protect the safety of their country.
It is dangerous to unquestioningly accept that the government always knows best because the government is looking out for your own safety.
Our countries founding fathers had principles for a reason. The reason is that they were very familiar with the governmental abuses that had gone on in England and elsewhere in the 150 years the preceded the American Revolution. They were determined to create a system that would be resistant to the failures of the 17th century.
Let's not sacrifice those principles for a little better safety and short-term risk reduction.
On the post: Homeland Security Says They Could Strip Search Every Airline Passenger If They Wanted To
Re:
Yes --- Outstanding line!!!
The supporters of the unconstitutional onslaught are either Cowards or else they are slimeballs with ulterior motives (relating to personal profit or personal power).
On the post: Homeland Security Says They Could Strip Search Every Airline Passenger If They Wanted To
Re: Re: Re:
The 4th amendment gives us guidance as to what enables a reasonable search. It's called Probable Cause
On the post: Homeland Security Says They Could Strip Search Every Airline Passenger If They Wanted To
Re:
Are you so damn ignorant that you don't know that this it the fundamental lying argument that every single demagogue, totalitarian, and dictator of any stripe -- be it communist, fascist, divine right absolutist, or good old fashioned despot, has used since the dawn of time to try to justify abusive treatment of their citizens, and preserve the level of obedience needed to maintain power.
If you don't know this, then many quotes from history can be given to you. But, then if I gave some of them to you now, you'd go all Godwin on me.
What you lack is any sense that the principles of freedom upon which our country is supposed to stand are of absolute prime importance. Those who love freedom judge that freedom is worth taking risk. If that were not so, then our country never would have come to be. Despots on the other hand are inwardly cowards.
If freedom doesn't concern you, and all you care about it order and maintaining authority, then one doesn't need to guess very hard on whose side you would have stood in 1776.
As an aside, I suspect the only reason you are here commenting on Techdirt is to make sure that 4th amendment rabble-rousers don't rain on your COICA parade.
On the post: Microsoft Continues Its Backdoor Legal Fight Against Android: Sues Barnes & Noble Over Nook
Next up, MS is going to sue over the ability to...breathe
Its all about trying to use patent licensing to take some of the profit from someone else's product by making ridiculous claims of innovation where clearly Microsoft didn't invent anything.
To quote Siegler: "Next up, Microsoft is going to sue over the ability to type, look, and maybe even breathe."
On the post: Senators Want Investigation On Massive Increase In Drug Prices... But Will They Really Seek A Solution?
A Regulatory Path to Monopoly-- explained:
The Makena situation is complicated, and it is a good illustration of unintended consequences of government regulation. If also demonstrates the consequences of lawsuits on the marketplace.
Despite the content of many comments here today, what this story DOES NOT involve is patents or research and development.
Rather what this story does show is how government intervention in the marketplace can produce an effective monopoly, even without a patent or other IP law at play.
Here are the facts:
--> Delalutin = Makena = hydroxyprogesterone
1) 1956: Delalutin is approved by the FDA for treatment of abnormal uterine bleeding.
2) 1970: FDA approves additional indication for treatment of uterine cancer.
3) 1973: Bristol Meyers Squibb requests approval for an indication to treat threatened miscarriage (The indication for which 'Makena' is now being marketed). The FDA denies this request, saying that there is too much risk of birth defects. This usage of Delalutin continues however as physicians prescribe it "off-label".
4) After patent expiration, multiple manufacturers produce/market hydroxyprogesterone in the US.
5) 1977, 1978: The FDA requires additional labeling warnings on Delalutin regarding birth-defects.
6) After the warnings are published, lawsuits blaming Delalutin for birth defects occur during the 1980's, prompting some manufacturers to withdraw from the market.
7) 1999: The FDA decides that further scientific evidence does not support the worries about birth defect risks, and the requirement for warnings against using the drugs in pregnant women are removed -- [but it's too late.]
8) 1999: Bristol, Meyers Squibb, the last remaining manufacturer, notifies the FDA without explanation that they had stopped supplying Delalutin several years earlier. [One may assume that BMS took this action because it was a low volume drug with low profit versus its legal liability.]
9) 2000: Delalutin's FDA approval is withdrawn.
10) 1990's - 2006: Certain small companies in the "compounding pharmacy" business continue to supply hydroxyprogesterone to physicians who continue to use it off-label to suppress miscarriage.
11) 2006: The FDA begins a new safety initiative to remove unapproved or untested drugs from the marketplace. The FDA begins forcing compounding pharmacies to stop making hydroxyprogesterone
***[ This event in effect removes all competition from the marketplace. It sets up a situation where the first company to return to the market after having done the testing required by the FDA will have a complete monopoly -- and surprise! Thats exactly what happened. ]
12) Feb 2011: FDA approves Makena for treatment of threatened preterm birth. [Their pharmaco-economists decide that the market will bear a very steep price of 30,000 for a full treatment course. Given that this is in the same price ball-park as in-vitro fertilization procedures, and given that there's NO COMPETITION, what is to stop them?]
13) Mar 2011: Senators call for hearings so they can rant about about price gouging.
--> What they should be looking at is how government regulation (step # 11) has resulted in loss of competition. If Congress had real leadership, or if executive branch regulators cared, the focus of the discussion would be : --> How to preserve both safety and competition. For now however, encouraging competition remains an afterthought at best.
This should be Adam Smith 101, but so many people don't seem to understand so let me say it a few times: Competition, Competition, Competition!!
For additional info, you can read here and here, and, here and here
On the post: Appeals Court Says It's Possible To Challenge Warrantless Wiretap Law Without Proving It Was Used On You
Federal attitude: 4th amendment is annoying
On the post: Mom Sues Preschool, Claiming It Didn't Prepare Her 4-Year-Old For The Ivy Leagues
Re:
On the post: Administration's New IP Enforcement Recommendations Will Only Serve To Make IP Less Respected
Re: Re: Odd Headline
There are a few abolitionists around here, but most regulars are not abolitionists. You will be hard pressed to come up with very many posts advocating that.
What you will find is a lot of people who think the principle of fairness has left IP law and IP enforcement a long time ago. The current laws are neither reasonable, nor do they promote progress and productivity.
They do protect the income of a very small group of people. This group rarely includes the actual creative individuals, but instead is mostly "suits".
Meanwhile a barrage of disinformation and lobbying continues in an attempt to maintain the status quo.
On the post: More Reasons Why Homeland Security Seizing Domain Names Is Unconstitutional
Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re:
On the post: Rep. Lofgren Again Explains How And Why Domain Seizures Violate The Law
Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re:
I guess we'll see if you actually make any distinction between the logical basis for policy and the specific legal arguments needed to support that policy.
On the post: NBA Ref Sues Reporter Over Tweet
On the post: Rep. Lofgren Again Explains How And Why Domain Seizures Violate The Law
Re: Re: Re: Re: Re: Re: Re: Re:
Suffice it to say however, there is not likely to be any rebuttal that will satisfy you because you already have cemented your opinions.
On the post: Rep. Lofgren Again Explains How And Why Domain Seizures Violate The Law
Re: Re: Re: Re: Re:
A person can be exactly correct in everything they say and still be grandstanding, so it's not the content of what is said, but the manner and purpose of the statements.
Morton is calling press conferences and making public statements, the facts of which may or may not be true, but an additional political message being transmitted is the following: 'Here's how we're attacking crime. See what a good job we are doing. Here's how valuable we are.'
In a government administrative job, this kind of behavior is good for your resume. It's good for your budget; and incidentally - it's good for campaign contributions to the guy who appointed you.
That's grandstanding.
On the post: Rep. Lofgren Again Explains How And Why Domain Seizures Violate The Law
Re: Re: Re:
Now think about the definition of grandstanding. If you insist on stating that Lofgren is grandstanding, but you can't admit that Morton is doing it then I call BS. That's as good as admitting you have a bias.
(As if we didn't already know that)
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