Posted on 08/29/2011 7:39:56 AM PDT by Marty62
But the obvious question is, when an already broke nation can not afford this monster, who will decide which patients win the medication lottery? The Doctors-No The Death Panel-probably The Chinese- most definitely.
Reality can be very ugly.
There are several reasons for these ongoing shortages, Jensen said. Most are due to problems in manufacturing, ranging from contamination to late delivery of raw materials. Other problems include misprints in the drug’s label or packaging and increased demand, she said.
Some people believe the FDA is causing part of the problem by not quickly inspecting plants to allow them to start producing the drug again, but Jensen challenged that notion.
“If the company is having a quality issue, the company doesn’t have to wait for an FDA inspection to restart the manufacture,” Jensen explained. The agency attempts to work with the companies to get drugs back into the market or tries to locate other sources for these drugs, she added.
However, Jensen noted that since most of these drugs are generic, companies don’t make much money on them and may, in some cases, opt to discontinue them.
Joseph M. Hill, director of federal legislative affairs at the American Society of Health-System Pharmacists, said that, “from our members’ perspective, it is kind of a crisis.”
“We are seeing a shortage of critical drugs in the areas of cancer therapy, pain medications, including anesthetics, and some nutritional products. Some of these are products that people cannot do without,” he said.
Another reason for the shortages, may be that companies are using them to increase prices, Dr. Otis Brawley, chief medical officer at the American Cancer Society, said.
“There is a pattern here. The drugs for which there is a shortage are the generic drugs, where the ability to make money is not as great,” he said. “If the drug is off the market, they can reprice it.”
While many of these delays are due to real manufacturing problems, “there are instances where I am certain that manufacture was stopped because they wanted to raise the price,” Brawley said.
http://news.yahoo.com/cancer-drug-shortages-getting-worse-fda-says-181011925.html
Maybe Obama will take over the pharmaceutical industry, too.
How low can these money hogs go? From the sty to the sewer to...........hell.
Any time the government gets between a consumer and a producer, market chaos results....................
“Maybe Obama will take over the pharmaceutical industry, too.”
Well, yeah, of course. There is a crisis, immediate don’t-read-the-bill government action is required.
I don’t believe the talk about how FDA and the Feds are not involved in the root cause of these shortages.
It is more expensive to produce drugs that require complex procedures.
Labeling? etc. Hardly. The situation exploded in 2010.
With the windfall that Big Pharma is expecting from Obamacare, any old excuse will do while they reduce costs=maximizing profits until their ship comes in.
THIS IS A MORAL AND ETHICAL ISSUE.
For any industry to claim clerical errors for 2 years when patients lives are at stake is unconscionable.
And people die!
It is not only “cancer” drugs.At any given time,we get memos at work ,stating that morphine,various anti-biotics etc..are in short supply.There was a recent problem with heparin .Seems to be happening more within the last 3 yrs or so.
Something’s up.
They’re hitting each and every industry at the various choke points.
They know how a capitalistic system works. And they are leaving no stone unturned in their broadbased attempts to undermine that system.
This is just one example. Yes, the consequences of these moves are serious. But when has bad outcomes ever stopped the left?
They’ll just blame it on whoever they feel like targeting at that particular moment.
While many of these delays are due to real manufacturing problems, there are instances where I am certain that manufacture was stopped because they wanted to raise the price, Brawley said.
This does not make any sense to me. It seems to fit into the standard template of blaming the big pharmaceutical companies. Generic drugs can be marketed once the original patent for the proprietary drug expires. A pharmaceutical company gets exclusive rights to a particular drug for a given period of time, and generally prices them high to cover the developmental costs. Once the patent expires, any company can produce a corresponding generic drug. These companies do not have the development costs to recoup for this drug, so all they have are the basic manufacturing costs. It should be possible to make just as much money producing the generic drug as the original company did when it had exclusive rights to the drug. If the drug is popular, it seems to me, there would be plenty of incentive for some drug company to produce the drug - all other things being equal. At least that's how it seems to me. I welcome any further illumination on this from FReepers who may have specific knowledge on the subject.
If there's a Ritalin shortage, there will be a completely new reality beyond ugly.
since the FDA will give preferential treatment to China, can we expect safety?
Have you heard of the IPAB--the "Independent" Payment Advisory Board? This is a non-clinical board that selects medical care based on its cost-benefit ratio. It's part of Obamacare, and it has big pharma scared.
How might an IPAB-run healthcare system work? It will necessarily look to generics as the first option in any doctor-prescribed script. That goes from anti-biotics, to cardio-vascular meds, all the way to oncology drugs.
If you're prescribed an older, less-efficacious generic, you'll have to prove it's not as effective for you, before you receive a script for a newer medicine. Don't get me wrong, generics were brand names at one time, and many of them work quite well. but considering that generics will be the first, and perhaps even the second line of treatment in most disease states, how will that be good for Big Pharma?
I wonder if it’s the beginnings of rationing.
This situation began in 2010. Obamacare signed into law by President Barack Obama on March 23, 2010.
Big Pharma was against HillaryCare. But somehow jumped on board with the ObamaCare bandwagon, even to the point of running ADS to support it.
Blaming big Pharma is not the issue. This is a moral and ethical issue. Big Pharma cut a deal for their stockholders.
Obamacare gets it’s fascist medical plan.
It is that simple and that evil. Government and Medicine should NEVER be partners. People die when that happens.
Yeah I know Grants and all. But this is the GOV TELLING med what to do. Big difference.
Yes.
The original company can make changes to the drug and keep exclusivity that way.
3.How long is exclusivity granted for?
It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge (PC) 180 days (this exclusivity is for ANDAs only)
See 21 C.F.R. 314.108 New Drug Product Exclusivity.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm
Not as bad as if there were a bi polar med shortage.
The point of my post number 10 (above) was that the blame was being focused on the Pharmaceutical companies. It think that it is something else. I think it was Thomas Sowell who said that there is no such thing as a shortage. There is only a shortage for given product at a given price. When the free market operates, there are no shortages. Cancer drugs are a dicey example, because of the life and death implications, but the laws of economics apply nevertheless. If the government is going to dictate how much it will pay for a certain drug, for example, it should come as no surprise that there will be a shortage at that price.
Still doesn’t make a lot of sense. Some of these conditions they say are causing current shortages have existed for many years. Well, unless they can say that the shortages are of generics of drugs which only recently lost their patent protection and competition forced the prices too low.
More information is still needed, and where are our great, investigative journalists to get to the bottom of the problem. Maybe they just aren’t interested while Obama is in the WH.
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