Chris, while I agree that there are shortages created without reason, I would argue that without the proft motive, we would not even have drugs like Doxil.

Why do people always have to look for conspiracies in everything. Drug manufacturers do not intentionally shut down production lines to cause shortages. If you had any clue of the time and expense involved in stopping and starting production on a drug, you would recognize the absurdity of this suggestion. It is not like just throwing a light switch the restart production, it takes a lot of time and manpower to get the facility back up and running. Manufacturers also do not make up claims of quality controls issues. Admitting to quality control issues brings extra scrutiny from the FDA, something no drug manufacturer wants to bring on themselves. I will agree that a drug company may stop making a drug if it becomes no longer profitable to do so, but this is a very rare occurrence. Usually a company cease production when the demand drops to a point where it can not justify keeping production going. This is usually due to a new drug coming out that works better and will result in the old drug's production dropping to the point where it may be profitable for only one company may continue to make it.

Shortages arise for a number of reasons. First, there may be a shortage of the precursors needed to make the drug. These precursors are usually made by other companies that the drug manufacturer has no control over. Second, a manufacturer may have quality issues develop with their production leading to a temporary shut down to address that issue. Third, shortages may develop due to the companies simply making too little of the drug. This happens with drugs that are not made continuously, but made in batches meant to last through the year. If the company under estimates the need due to changing demand, a shortage my develop. Lastly, a shortage may develop because demand for a drug exceeds the production capacity. This can happen either due to an unforeseen increase in demand that manufacturers had not planned for or due to the loss of a manufacturer due to something like a company going out of business or a natural or other type of disaster like a fire that closes a facility.

It is good to see the FDA paying mroe attention to the supply of critical drugs and trying to be more proactive to prevent shortages. They have a long way to go based on the number of drugs currently in short supply.

Saving a human life should not be done for a profit -that's really disgusting !

Any drug company allowed to sell in this country that makes a cancer drug should be required by LAW to provide adequate amounts for any person requiring it.

YOU CAN'T TELL ME THESE SOB'S ARE NOT MAKING ENOUGH MONEY.

Jaga, are you saying that drug companies should make their products out of the goodness of their heart? If so, we can go back to using leaches to cure disease. Nothing is free and unless there is a motivation for innovation, things won't be produced. Look at the lack of success in the renewable energy sector.

That's my point. BD

IF they want to do business in the USA they should have a humanitarian component to that business model.

So the FDA. With Prez O's Instruction. is importing the drug from an Indian Company. Kudos to ALL Three

I agree with Chris. If a drug company stops production of a drug, it should immediatly have its patent expire so that anyone can make generics of it.

JS in SD...you raise some legitimate points. But the fact that the drug was readily available outside of this country would seem to refute your arguement.

As for seeing "conspiracies" everywhere...it's no "conspiracy" that companies are in business to maximize profits. We see plenty of examples of this every day. From Enron traders laughing about grandma not being able to pay her electric bill to banks selling investments that were specifically designed to fail and then profiting from that failure. BP knowingly using equipment that had failed safety inspections. Southwest Airlines bribing aviation inspectors. Media companies hacking and deleting the messages on a dead gils answering machine. The list goes on...and on...and on...

Maybe a better question would be...why do you pretend that an inhuman entity (a corporation) is going to act with human compassion or according to human values? Because they're run by humans? That's debatable.

Why should companies care about someones life, when they can make "real" money on shortages! And c'mon do you really believe that the FDA would not take into account the lives of all the people affected?

First of all i am being sarcastic! I wish our medical industry was privatized where competition would bring prices down, and companies who provide a "good" service and product would still reap there own reward, but for this sham of a governmental department called the "FDA" only allows for what they deem to be good for corporations profits first, before peoples health and lives!

Cancer is a HUGE ($$$) industry. If you have never seen the documentary "Burzynski"....you must watch it....it show a man, who has a way to treat cancer without the use of chemotherapy, and has a better survival / cure rate than any other treatment around, and the FDA, The NCI (National Cancer Institute), the state of Texas and the US Government all took Dr. Burzynski to court to have him stop this treatment....in court, his patients came to his defense, and the court did not want to hear them, because (here is the craziest part) the case was not about the patients being cured, it was about Dr. administering an "unapproved" treatment. It is disgusting to see what really goes on!

Chris, the drugs in question are no longer patented, but generics.

Here's the problem, there is very little profit margin in these drugs. Lets say a drug takes 10 dollars to make with a 1 dollar profit margin (Note this is nearly 5x the estimated profit margin of generic drugs, usually hovering at 2%). Year 1 they make 1400 and sell 1300. They have made 300 dollars, but they were almost saturated, so they increase their supply to 1500 for estimated demand increase. Lets say demand stays the same at 1300, now they have lost 700 dollars, over double the profits from the previous year.

When dealing with items of low cost margin, industry will always try and estimate demand. This will lead to some years of too much supply, other years of too little supply. On top of that the FDA has almost a 2 year registration process for new drug manufacturers for even generics, which means the market place will always be behind when demand starts to increase rapidly. It simply can't keep up.

The only true solution to this would be for the government to buy X amount a year and pad in a 5% margin of over-demand estimation to cover times when demand increases more than expected. This would cost taxpayers money.

To say this is about "greedy pill manufacturers" ignores BASIC ECONOMICS. This isn't a hard topic to dissect. Wish people would think logically about the causes for actual shortages into jumping into irrational emotional ALL CORPORATIONS ARE EVIL!!!1!! rants.

The masses around the world and the various governments have been pouring money into cancer research which would include the drug treatments.

The masses in this country i.e. the USA, have given enormous amounts of monies through out the years for cancer treatment research for as long as I can remember.

So why is it that there are folks giving the impression that it is only the drug companies who are putting up the billions of dollar for cancer treatment and research R&D?

When do the masses get some of their money back that they have given to help create these drugs?

Where does NIH get the majority of their money from to do their research? No doubt from our govt using our taxes that we have had to pay.

It is time that healthcare in this country should not be for profit. The pharma folks have been getting a pass for nothing, because of this belief about them putting up all the money for R&D when it is not true period.

The cost of these drugs and treatments are nationalized yet the profit from these drugs and treatments are privatized.

What's new..... same old same old capitalism of skrw the American people period.

Another critical shortage (a children's cancer treatment) in the same month appears not to be a coincident. I wonder what the real reason is for having so many shortages for major medicines.

All that needs to be done is require that drug designers cannot also control the means of production.

Allow them to reap the rewards for patenting a drug, but under no circumstances should they also control how many supply lines are producing it. Instead the designers make their money from the licensing of the patent to the producers (just require that the license is based on time and not on rate of production, otherwise nothing is solved).

The best part is that the producers will produce the drug to meet the demand, if they do not, there are other producers that will in their place. If the government needs to boost production due to orphan illnesses that do not have enough demand to spur supply, that's where subsidies could come into play.

seriously,

but that basically means you are for getting rid of the patent system.

@ Jonathan-1917156

How so? I'm not taking away the designer's reward for designing, I'm just creating a physical and operational divide between the businesses that design and the businesses that produce.

There are tons of inventors in the world that make money off of licensing their patents, why shouldn't drug designers?

Heck, I'd be fine with the drug designer being able to also manufacture, but the law should state that they cannot ever be the sole producer of any drug.

Considering the fact that the pharmaceutical companies are raking Americans over the coals on drug prices while they are miniscule by comparison (in most cases) in Mexico and Canada, I see these companies as abusing monopoly power to drive prices waaaaaaaaay up. The fact that generics are low priced also serves to drive the point home that the costs of production are miniscule.

On life saving drugs, this issue is blatantly unethical and is a drain on the US citizenry for their largesse.

Also, on an "eggs in one basket" angle, this is risky, as can be seen in the article(s) related to this FDA decision...why was a single company in charge of producing an entire nation's life saving drug(s).

that whole eggs in one basket thing is actually the point of a patent. It is a legislated monopoly.

Hmmmm....US citizens can't get drugs from Canada by mail or by going there and bringing them back legally.............but in a remarkably instantaneous amount of time (FDA-wise) we are bringing in drugs from India.

OK, does this mean we trust Indian drugs and can buy them over the internet............No, it means that we artificially restrict drugs to "protect" our drug companies..........Even the ones who are making most of their drugs overseas. Good for capitalism bad for patients' bank accounts to have to pay inflated prices

OBXRon

By buying drugs in Canada and bringing them into the US, you are destroying the planned nature of the Canadian drug system, where each province negotiates with each of the drug companies what they expect the supply to be, at a discount. So when an american goes and buys drugs from one of the canadian provinces, it is essentially taking drugs away from the Canadians for whom those lower prices were negotiated for.

Maybe the solution for the US is to devise a planned supply system were needs are predicted, and the drug company is paid for meeting that supply rather than paid for the drugs that they sell.

Anyone who want to believe that these drugs are not cashcows for these companies need to have their heads examined. Imagine paying say 2 to 5 thousand dollars per dose for a cancer treatment drug? No profit huh, especially when the masses have contributed billions of dollars in donations to cancer research and treatment throughout the ages.

There is no profit in a cure, there is only profit in the treatment especially in the USA where we have a for profit healthcare system.

Look at the HIV/AIDs cocktail that is being used in Africa for example, it cost pennies on the dollar for treatment and their patients disease is under control while here in the USA it is not and is starting to spread again. Some patients cannot even afford the treatment here in this country because of the cost.

I am so tired of hearing the drug companies are spending so much money for R&D crap. How about NASA and all the monies that this country's citizens put up for these missions and for R&D to take place in zero gravity etc. Many of the new technologies were given to these corporations for development, yet we pay the exorbitant price for the product afterwards.

People need to start thinking for themselves instead of just accepting the stuff the media etc pushes. Was watching to a newstalk program recently, where the guest was trying to state that the upward price of gas could be problematic for President Obama's re-election because he did not agree to the Keystone Pipeline and the drilling in protected public lands blah blah blah.

He was also trying to give the impression that we needed to drill more in those protected public lands in Alaska etc to gain energy independence. LOL The host reminded him that oil harvested in the USA is sold on the world market to the highest bidder and thus would not bring us any closer to being energy independent. LOL He could not continue in that vein when he realized the host was not going to let him get away with making obviously false statements.

Now we have been told all sort of untruths about all sort of things throughout the years from about the efficacy of the war on drugs decreasing the amounts of illegal drugs coming into our country, to a public not for profit healthcare plan like Medicare For All will produce death panels, to importing drugs from Canada or Europe is not safe and a lot of nonsense inbetween including that the housing bubble was caused by a bunch of poor people buying homes they cannot affford. All the while to keep the status quo of skrwing the masses. Well most of us know that these things are not true.

This idea that big Pharma is not making enough profit is nonsense. Celebrex used to cost 10dollar per pill. I was prescribed some by doctor and remember what the bill stated. Is it any cheaper now I havent the faintest idea. For example imagine an anti-allergy nasal mist cost 175 dollar per little bottle, etc. If something like that can cost that sort of money imagine the cost for cancer treatment drugs especially the newer drugs on the market. Even some generics are still very costly. Why? Manufacturing these drugs are done in countries like India, Pakistan, China to cut cost. So these companies are indeed making obscene profits whether we want to believe it or not.

Other countries do not pay the same as we do for drugs, for them the cost is lower, yet we are constantly bombarded with the talk about the cost of R&D. It was once noted that these drugs R&D are paid for by the American masses while other countries received the benefit of lower prices. That is because those countries have their not for profit national healthcare plan in place unlike us. thus have clout when purchasing in bulk.

Why is it that we cannot import drugs from Canada at a cheaper cost? Why is it that the Medicare Part D cannot import drugs from Canada? Why is it some drugs are not allowed to be used or imported here from Europe? These are drugs that have been used for years for treatments over there? Could it be because it would be cheaper?

Ranted out....

Peace... etc etc etc...

if it costs 6000 dollars per dose, but the company is restricted to charge 5000 dollars per dose, then the company loses 1000 dollars per dose.

Now I don't know the numbers for these drugs, but a lot of drugs have EXTREMELY high fixed costs and small markets which means that the pricing needs to be high to justify even producing the drug. Usually when situations like this happen, the reason why it is difficult to find supply is because the market is actually quite small, so the company tends to keep production rates low.

As for your Canadian prices rant, you obviously didn't even read what I said. Canada doesn't have an open drug market, it is MANAGED, meaning that the drug companies are essentially paid to provide a certain quantity of drug over a certain period of time, to meet CANADIAN needs. That means that if americans go to canada and buy drugs to bring back to the US, that is potentially going to cause shortages for Canadians. So I guess you don't give a @!$%# about the lives of Canadians, or the taxpayers that often subsidize these drugs for the Canadian market.

Then the USA can do the same deal with the drug manufacturers in Canada. We already have managed care in the USA too so why is Medicare Part D costing so much? Isn't it because some of these polititians have made deals with the drug manufactors in the USA to pay a higher price for the same drugs?

I do not have a problem with these companies making a profit, but I do have a problem when they make a profit at both ends... i.e the get tax breaks etc and also can sell their drugs at a higher cost in the American market, something they cannot do in other countries from the look of things.

Price gouging for something that is necessary to save lives is wrong imo.

And maybe the US should do the same thing, but PLEASE don't suggest that americans get their drugs from Canada, because the system in Canada (which generally gets the same drugs from the same american pharma companies) just isn't capable of taking on the extra demand of americans buying drugs from Canada.

Jonathan-1917156

that whole eggs in one basket thing is actually the point of a patent. It is a legislated monopoly.

Indeed, and I'm fine with that when the patent is for a new type of aircraft or whatnot...but we're talking about life-saving drugs here, not just any innovation, but one that directly has an impact on whether someone withers away and dies from an otherwise preventable illness.

I don't want to take away the rewards for innovating, that's why charging a royalty (not denominated by quantity produced, but by duration) is fine in my eyes. The problem with allowing a drug company to also control the sole means of production poses both a logistical risk and the potential to exercise a conflict of interest in a highly inelastic market.

Canada doesn't have an open drug market, it is MANAGED, meaning that the drug companies are essentially paid to provide a certain quantity of drug over a certain period of time, to meet CANADIAN needs

Yes, but Mexico does, and the same prescription drugs are far and away cheaper there as well. Drug designers are exercising price discrimination to maximize profits and they do this by segmenting their market. For example, look at the prices of movies and software in the US and elsewhere. Notice how much a DVD costs in the US vs. Asia? They segment the market artificially by utilizing "country codes" which are designed to do nothing more than prevent a person from watching a DVD that doesn't have a compatible code with their player. This is to allow a pricing disparity to exist much in the same way that one creates a dyke to reclaim and develop land that is effectively below sea level.

If drug companies were operating at narrow margins, then there would be such a massive market for generics to pick up the slack!

If the US did not allow the drug companies to segment their market here in the US, the prices of the drugs would plummet and the designers would have to produce much more to maintain profitability. There would always be the exception with regard to orphan illnesses, but the government already subsidizes their support...I would boost such subsidies simultaneously of my lift & separate strategy ^_^

Typo "If drug companies were operating at narrow margins, then there WOULDN'T be such a massive market for generics to pick of the slack.

First, a patent is a patent. The problem in this case isn't the patent, but the market. These types of drugs are generally VERY small market, meaning that there probably isn't going to be any more manufacturers willing to get into that market, and pay the patent fee. So again, we get back to 'invalidating the patent'. There are MANY patents for life saving devices or drugs, they are no different from any other patent.

Because the market for these drugs are generally extremely small, it means that the manufacturer needs to either produce far more than is needed, and lose money on unsold drugs, or they produce about what they think is needed and run the risk of a spurt in demand causing a shortage. That is the reality of production planning, and the only way that the economics of it is going to change is if the company is all of a sudden paid to produce a larger than needed quantity (supply managed production instead of demand managed production). The US government, hell US policy refuses to produce using that philosophy, so it just isn't going to happen. The patent system has NOTHING to do with that.

And as far as Canada is concerned, you didn't mention mexico, you mentioned Canada, all I tried to do is say WHY that can't happen with regards to Canada. As far as Mexico, there are very legitimate issues with regards to the integrity of the mexican drug supply and I personally wouldn't trust it.

And if drug companies were operating at narrow margins, there may not be a problem with supply of existing drugs, but there sure would be a problem with the development of new drugs.

There are already special rules on drug patents, they have significantly shorter lifespans than technology patents do...there most definitely is a patent issue here. Also, take a look at the drugs that are in short supply, these are chemotherapy drugs...there is A LOT of demand for these medications...we're not talking about anti-venom for coral snakes here.

Also, I did mention further subsidizing orphan diseases to assure an adequate supply when the R&D and deployment is more costly than the market demand can support to generate a supply.

And as far as Canada is concerned, you didn't mention mexico, you mentioned Canada

I did mention Mexico, it was in my post #1.16 about midway when I also mentioned Canada ;P

As far as Mexico, there are very legitimate issues with regards to the integrity of the mexican drug supply and I personally wouldn't trust it.

I haven't heard of any problems stemming from people traveling across the border to Mexico to buy drugs from legit pharmacies, I've only read about people getting scammed with fake drugs they buy from unauthorized dealers in the US.

Also, regarding Canada, would you like to explain the rationale regarding how a country with a far smaller population and volume-purchasing-power is able to exercise a cut rate for drugs compared to the US? Or is it that Canada refuses to pay the prices that the US pays for the same drugs, and thus the drug company slashes the rate so that they can make more money by meeting Canada's demand.

Price discrimination my friend

And if drug companies were operating at narrow margins, there may not be a problem with supply of existing drugs, but there sure would be a problem with the development of new drugs.

Wake me up when the drug companies aren't leached tightly onto the hides of university graduate labs for most of their new designs.

I still don't see an argument against separating a drug company from its ability to also be the sole producer of its design. They still stand to make billions off of royalties of their patents, if anything, separating them from production actually spurs them to work harder at innovation because they won't be tied to the logistics of deployment. Additionally, they could still produce if they wish, but they would just not be the sole producer

Also, regarding Canada, would you like to explain the rationale regarding how a country with a far smaller population and volume-purchasing-power is able to exercise a cut rate for drugs compared to the US? Or is it that Canada refuses to pay the prices that the US pays for the same drugs, and thus the drug company slashes the rate so that they can make more money by meeting Canada's demand.

There are several reasons that you need to look at in combination (not just one reason but all of them together).

1) Canada is not a core market, with 1 10th the population, it can't be, therefore the market that Canada provides is on top of the sales in the primary market (in most cases the US, but in others, europe). This means that the 'fixed costs' associated with the research and development and initial production are already generally covered.

2) Canada pays the companies to fill a certain supply, or within a minimum and maximum supply, meaning that no matter what, the drug companies get paid for a particular amount of drug production regardless of actual demand

3) Because of 2) the different provinces (it is done by province, not by the federal government) negotiates a discount rate for that guaranteed supply of drugs.

Now in the United States, the VA is able to do number 3, but the Medicare Part D bill specifically forbid medicare from negotiating discount rates for volume. This way the pharma companies can get maximum revenue with increased sales.

In the case of the drugs in the article however, none of this is affecting it other than item number 2. If the drug companies were paid say to guarantee a certain supply, and that supply provided a reasonable buffer in terms of actual demand and the supply, then the problem would be resolved. But those drugs are NOT high volume drugs, they are EXTREMELY specialized limited use drugs. This means that the planning of the drug company needs to balance out how much they produce with the risk that they will have a lot of unusable drug being made, losing the company millions. Sometimes it works, sometimes it doesn't.

In the case of these drugs, I seriously doubt that there is even enough demand to justify any company becoming a second source. These are again, not high volume drugs, they are very specialized.

1) Canada is not a core market, with 1 10th the population, it can't be, therefore the market that Canada provides is on top of the sales in the primary market (in most cases the US, but in others, europe). This means that the 'fixed costs' associated with the research and development and initial production are already generally covered.

The costs are asymmetrically allocated against the customers that are most willing to pay those costs. Companies will charge what the market will bear. The interesting thing is when there are massive disparities in regional supply/demand equequilibria (hence my analogy to a dyke allowing one to develop land below sea level)

Ordinarily, when a region doesn't have a massive amount of nascent demand and or wealth, products are ordinarily far more expensive because the region cannot negotiate a discounted price because the demand isn't great enough to attract a greater supply (hence a naturally higher equilibrium). Like auto parts in South America or Levis Jeans in Eastern Europe...this is partly reflected by differences in PPP

What's interesting is that the USA, with all of its wealth and its still extremely highly educated and high demand for the latest in innovations that it would negotiate a lower price than countries with less internal wealth and nascent demand...yet it does not.

Ordinarily, an unrestricted market will purchase inputs from the cheapest supplier (assuming homogeneous quality). Yet prices of the same products are vastly different in both Canada AND Mexico compared to the US...AND the US has the highest nascent demand!

Software and movies have country codes to segment American and Asian and European markets; drug-makers lobby Washington to hold the American market hostage.

2) Canada pays the companies to fill a certain supply, or within a minimum and maximum supply, meaning that no matter what, the drug companies get paid for a particular amount of drug production regardless of actual demand

Agreed, Canada has great pharma-planning...but it doesn't explain Mexico, and it doesn't explain why both Canada and Mexico have lower costs of drugs when nascent American demand is greater both in aggregate and per capita (in some respects).

3) Because of 2) the different provinces (it is done by province, not by the federal government) negotiates a discount rate for that guaranteed supply of drugs.

Perhaps the US citizen pays more for drugs because we have not organized a vast purchasing agreement with the manufacturers...but it doesn't explain why Americans cannot mail-order drugs from overseas but have to physically travel outside the country to do it.

Why are we locked-in?

In the case of these drugs, I seriously doubt that there is even enough demand to justify any company becoming a second source. These are again, not high volume drugs, they are very specialized.

I was deliberate when I mentioned coral snake anti-venom above

Wyeth management was looking to make themselves an acquisition target and they started shutting down their lower-margin operations to boost their sale-price...it attracted Pfizer...just don't ever get bit by a coral snake, because now you probably can't be treated.

your first comment is true in a non managed market, but as I have said, Canada is a managed market, and they buy a volume amount and therefore get a volume discount. The drug companies are willing to do this because Canada isn't a core market. This causes the economics to flip.

As for mexico, I have no clue, and I refuse to even go there due to certain activities of corruption that occur there and are systemic. I tend to pay very little attention to the country, and while that may be considered ignorance on my part and I should learn about what is happening there, I personally wish to remain ignorant about that country.

Talk to the fda about the regulations, my only comment with regards to Canada is again related to the issue that if people take the supply from Canada, then Canadians will all of a sudden be short ended. As for the laws, I believe the law is an FDA law that prevents people from mail ordering, but the Canadian government (the federal one) has stated that if the problem becomes serious, that legislation would be drafted that would ban the export from Canada, right now there is no ban on export because it was never considered a problem. (in actual fact, when the canadian system was put in place, Canada was having to pay the higher prices, but that problem has reversed now).

Well I don't know about the coral snake thing, I was referring more to the cancer drugs, of which I have been a recipient of a few of them in my 3 bouts of cancer.

Look, I am not saying that the system is perfect, hell it is far from it, but the system needs to be fixed in a way that doesn't take away peoples rights, and essentially nullifying some patents isn't the solution (unless you want to do away with patents altogether). What might need to happen is that once the FDA approves a drug, the company needs to guarantee supply. In the case of coral snake antivenom, that would be VERY difficult to determine how much is needed during any given year, so supply planning would be very sketchy.

@ Jonathan-1917156

I still disagree with you regarding how you jump to nullifying patents simply by my suggestion of separating the developers from also being the exclusive producers. These two things are not one and the same...sure there's overlap, but leasing the patents is still a massive revenue driver and these companies would still stand to make billions.

Honestly, my primary concern with such a system would be that these designers would refuse to lease in general, or would require such a prohibitively high price to play, it wouldn't solve anything and actually make things worse. Or that they wouldn't pursue drugs where they didn't anticipate a high bid on their patents...but again, that's part of where my subsidy suggestion would play to.

Anyway...agreed, super-complex problems, no easy 10-step solutions...lots of conflicts of interest, lots of corruption and politicking, lots of genuine challenges and logistical nightmares.

Care to take a crack at what you think may work?

not anymore, once I sell my company, I am gone, so I won't have to worry about it.

gee, thanks

;P

hehehe

fire up our manufacturing facilities or is this just a back door way to export more jobs

What manufacturing facilities?

Although hard to find on a prescription bottle (as this is repackaged from the pharmacy stock bottle), a large number of drugs are not made in this country) the R&D maybe done here and the production off-shored (Puerto Rico, UK, Canada, Israel, India, Italy, Sweden come to mind) and rebranded under a US manufacturer. This is much more obvious if you have an un-repackaged drug (Intravenous vials, inhalers, tubes of skin and eye creams and ointments, etc.

Example - Flovent HFA (fluticasone inhaler) Branded by GlaxoSmithKline, Research Triangle Park, NC 27709; made in Scotland.

I've made a number of drugs as one of the guys working on the floor. I'm American working in America. I can assure you there are manufacturing facilities.

The shortage was created on purpose to increase the demand and as a result the cost passed to those suffering. This is a sick society where gread took over everything

Jaga, your whole rant is completely wrong. There is nothing true in what you stated.

@ Jesse-Az

Agreed, the likelihood that Jaga is correct is miniscule, and such allegations (if true) could probably attract some serious prison terms for those involved if Jaga is correct.

My major issue here is that we put the manufacture of an important drug in the hands of one producer!

Aside from the obvious that pharmaceutical companies regulate price by restricting product (in many instances), from a logistical standpoint we should have redundancies built into the system so that life saving drugs are plentiful and that the risks of complete catastrophic failure is reduced because there are multiple parties producing simultaneously.

mFDA's Lipodox deal is a temporary, limited arrangement with Sun Pharma Global FZE and its distributor, Caraco Pharmaceutical Laboratories Ltd. The agency has authority to import foreign drugs on a limited basis in rare cases of a shortage of critical drugs.

FDA officials said that they had previously inspected the Indian firm, which already exports the drug to other companies.

Both of the drugs mentioined above are out of their period of patent protection. They are low earners, and not on the front page of big pharma. The blatant hipocrisy of the government and big pharma, proven by this article, big pharma and the FDA's own admissions, is that it is not AS profitable to make these drugs "here" as it used to be - that is the reason for patent protection - but the government WILL NOT ALLOW US CITIZENS TO BUY DRUGS THEY (AND HOSPITALS) ARE WITHOUT - even if it causes larger increases in the disease(s) even unto death.

I know, in my heart, if any of those children's parents knew that they could buy the drug they needed for their children from India, WITHOUT RETRIBUTION FROM THE GOVERNMENT/FDA, they would have done so in a heartbeat. Now, there has been irreperable harm done to both classes of patients by greed.

Americans have shouldered the majority of R&D in big pharma, by paying prices higher than anywhere else in the world - that's fine, it is just a continuation of the American Way - the USA gives away millions upon millions of tons of grain and foodstuffs, foreign aid to 150 countries (most of whom don't like us), etc., and refusing to let Americans, who have footed this bill for so long, buy available drugs from FDA inspected plants, is abominably fascist IMHO.

@ Steve-614202-1507121

Agreed +1 for you

I would fear that if we take away the profit motivation, we would not see companies investing in R&D to produce newer, better and more effective drugs. Reaserch takes money. There would be some endowments and philanthropical types who may give to research, but would it be enough to fund the research?

Bookem' DannoI would fear that if we take away the profit motivation, we would not see companies investing in R&D

If drug companies would stop plastering the airwaves with ads encouraging people to diagnose themselves the money could be applied to R&D. Also, the federal government (you and me) has traditionally supplied R&D money through grants to universitys - unless the republicans have also decimated this portion of the budget.

A lot of companies are too risk adverse to do discovery level research. That takes academic research which is funded by grants, some private, some public. Republicans had a pretty big attack on the NSF back in 2010. The NSF is one of the major grant providers for discovery-level research. They invited the public to submit examples of stupid grants to use as cannon fodder for cutting scientific research. It was called YouCut. Last I knew, there's been calls to cut grants for Arctic research, the kind of research that could extend our economic exclusive zone in the arctic and secure oil reserves.

jrae-1215199:

If drug companies would stop plastering the airwaves with ads encouraging people to diagnose themselves the money could be applied to R&D.

They run those ads to increase demand for their few experiments that actually result in a successful drug. Putting a dollar into advertising results in them making well more than that dollar back (else they wouldn't keep running the ads). It is profits from these drugs that allow them to do ANY R&D. Putting the advertising money into R&D instead of advertising would just result in them having less to spend on R&D. If a drug company doesn't make money, they don't make drugs for very long (or employ manufacturing and R&D staff or pay property, business, and income taxes).

As for running ads encouraging people to self-diagnose... First, if you have much experience with the mainstream medical system in the U.S. (and I suspect probably most everywhere else), doctors spend little time with each patient and often miss things -- an informed (i.e., one that is engaging in what you refer to as "self diagnosis") patient is significantly more likely to have a successful outcome (for example because they recognize due to an ad that the set of symptoms they are experiencing may be related and not just "normal aging" and therefore mention the symptoms to the doctor even if she doesn't ask). Second, all the drugs we are talking about here are prescription drugs and if a doctor doesn't think they are appropriate, she should not prescribe them no matter what the patient requests - if a drug is being mis-prescribed due to advertising, that's the doctors' failings, not the drug company's failing.

Reaserch takes money.

It is apparent that the only drug R&D is done buy private ventures. Here is a novel idea, how about use some public grants funds for drug R&D and profit? How many research papers do we really need on Virginia Woolf?!

Yes! Please don't forget that MANY of the major drug companies actually simply buy patents from Universities and merely spend the dough necessary to carry the designs through FDA scrutiny.

We have a nice system with regard to publicly funded R&D, I think that we need to work on removing the conflicts of interest between design and production however.

Why do men pay more for health insurance then women? Why do women like you insist I pay for your birth control? What happened to personal responsibility. You are a sad person that puts birth control over finding a cure for a life threatening disease.

Kevin -

Why do men pay more for health insurance then women?

Because actuaries know that men's health expenses are higher than womens.

Why do women like you insist I pay for your birth control? What happened to personal responsibility. You are a sad person that puts birth control over finding a cure for a life threatening disease.

Apples and oranges Kevin.

The cost of birth control is a fraction of a pregnancy taken to term, and even a smaller fraction of a pre-term pregnancy that ends up in a neonatal ICU. You want health costs even higher, stop paying for birth control.

The really sad person is one who fails to distinguish the difference between the cost of care at the present and the cost of finding cures for life-threatening diseases.

http://www.health-insurance.org/woman-health-care-costs

Actual Differences in Health Costs – Women vs. Men

Ironically, because women are more conscious of their healthcare and visit doctors more regularly than men, health insurers charge that they cost more to insure than men. This disparity of costs for healthcare coverage can best be seen by comparing cost quotes online for women and men of exactly the same age and health risk and with the same medical pasts.The difference in quotes can range from hundreds of dollars a year to over a thousand!

In fact, the average difference is 35% more for a woman's health insurance plan – just to have the same insurance coverage as a man! This percentage also fluctuates depending on the state in which you're being insured. For example, in Texas, women aged 25-29 pay 40% more for coverage than men of the same age. In Nebraska, the cost difference is a more modest 32% more for a policy than a man in the same state has to pay. As a woman moves away from the age of child-bearing, the percentage rate drops to only 38% more than a man would pay. But women in Iowa and Ohio pay an astounding 49% more for the same coverage as men of the same age and medical history!

Just one moire glaring reason we need a universal single payer health care system.

Not a bad conclusion..

But this is 'Merka. Healthcare isn't about healthcare, it's about money. That's all it's about..

We haven't quite evolved to the point where healthcare is actually about creating, and maintaining a stronger, healthier, more prosperous society..

Someday maybe. But I wouldn't hold your breath..

we have as much right to birth control paid for by insurance companies as men have the right to have viagra paid for by their insurance companies

I'm not sure that I think insurance companies (or medicare) should be required to pay for Viagra. However, at least Viagra is (if properly prescribed) treating a dysfunction -- i.e., the body is not working the way it is "supposed to" and Viagra is compensating for that to restore "normal function".

Birth control, on the other hand, is preventing the body from functioning as intended (i.e., as it evolved to). It's very odd to expect an insurance company to be required to pay both for compensating for a "broken" reproductive system (i.e., paying for fertility treatments) AND to pay to break it (i.e., paying for birth control).

It's true that birth control probably saves insurance companies money in the short term. It's pretty cheap compared to a pregnancy and if the insured is going to move onto another job/insurance company in the next few years, slightly encouraging birth control by paying for it may stick the next insurance company with the cost of pregnancy rather then the current insurance company. So, if I were an insurance company, I'd probably pay for it just to save money (at least on policies aimed at lower income folks - no rational person who can afford birth control would not buy it out of their own pocket if insurance didn't cover it).

Birth control is like toothpaste, healthy food, gym memberships, and having a roof over your head. All may improve health and reduce health care costs. None, however, treat an abnormal medical condition (unless "being a woman" is considered to be be an abnormal medical condition - not a view I hold). None are unanticipated expenses (that's what "insurance" is intended to cover -- unanticipated and typically large expenses) any more than getting a haircut is an unanticipated expense. None are appropriate for "insurance" coverage. Perhaps they would be appropriate for some sort of "volume discount" bundled prepaid contract deals - just as joining CostCo is for some people.

Any requirement that health insurance companies include coverage for birth control simply spreads the cost of birth control across all women of a given age range (since gender and age may be used in determining insurance premiums even under the PPACA) - including those who don't use it (for example, lesbians, celibate females, those married to men who have had vasectomies, those who are infertile, those who insist their partners use condoms, and those whose religious or moral beliefs preclude them from using birth control).

Kevin, I am an actuary and please let me inform you that women pay a lot more for health care in their younger years because of pregnancy and childbirth. As people get older men start to pay more because they tend to have more illnesses, particularly sudden death type illness that cost a lot (think heart attacks) and at that age women are not having children so they cost less to cover. And for the record, most insurance companies have little or no issue with paying for birth control as it's much cheaper then paying for pregnancy, childbirth, and subsequent coverage of the kid. Fights over birth control are a political issue stemming from giving religious nuts power.

The industry practice and regulation has morphed from the deliberate and painfully slow process that served us well in the days of Thalidomide into a set of fast-moving goalposts that makes a process completely fine one year and unable to guarantee quality the next.

The american people should be way more concerned about drug shortages than how often the Obama's go to Church.

Petty partisan politics are and always have been a diversionary tactic.

you're wearing a tin foil hat rigth now, aren't you?

Really? That's the ONLY reason?

Is it better that an effective life saving or life extending drug had never been developed or that it had been developed but was in short supply occasionally? I suppose the former case seems "fairer" (everyone dies that could have benefited from the drug since they have no idea it could have existed) while the latter seems "cruel" (a few people die while most survive the disease) to some (not me though).

Note that in 1900, no one complained about the limited supply of any of the drugs that we've seen shortages in recently -- or any of the very effective drugs that have been created in the last thirty years by for-profit corporations and haven't happened to be in short supply and have extended lives by millions of person-years.

Anyone who wants to eliminate the profit motive from medical research must either believe politicians will do a better job of gathering and allocating resources OR they really don't want to advance health care -- they just want to make sure that everyone has the same crappy healthcare.

The "gathering and allocating" resource wisdom of government is unclear - note the deficit, the battle over tax rates, cash-for-clunkers, Solyndra, Katrina, California HSR, the Big Dig, oil well safety regulation in the GOM.

Oh, and can you imagine President [Romney, Santorum] signing a bill to fund research for a more effective and safer "morning after" pill?

Where would all the folks who have already been treated with this drug be if the pharmaceutical company didn't bother to develop the drug in the first place?

Because, of course, wild animals and humans 1000 years ago never got cancer. I suppose the first case of cancer was when, in the mid 1800's or something like that (I actually don't know when the first "unnatural" forms of pest control or "synthetic" fertilizers were introduced).

Although, I would agree that people probably got cancer less frequently 1000 years ago. But that's probably because they didn't live long enough to be at high risk because they usually died first of some disease/condition that is treatable/preventable today (such as antibiotics for bacterial diseases, vaccines for viruses - oh, wait, those are 'big pharma' products).

A decade ago (I was too lazy to look for more recent data), the median age of cancer diagnosis across all types of cancer, both genders, and all races was 67 years old. If I recall correctly, a white male who reached 10 years of age (i.e., beyond infant mortality effects) had a remaining average life expectancy of 51 or so years (i.e., would "on the average" obtain the age of only 61 before dying). Generally, people just didn't live long enough to get cancer as often.