This will create a much more expensive “generic” drug.
The healthcare cost are about to skyrocket, but they will use the Pharmaceuticals RESEARCH as the corruption. The Pharmaceutical companies are OK with it, because their prices will increase for drugs that they have already classified as generics.
The GOVERNMENT – PHARMACEUTICAL complex.
IT’s the GOVERNMENT stupid.
When the government says that it’s “centralizing” something it means that it’s creating a monopoly.
Don’t get me wrong. Some (very few) monopolies are needed. Food and some defense and even MONETARY institutions. But, no one asks me about these things. So, maybe they should not, yet what about consulting HISTORY? These same mistakes have been made time and again by the SAME people (entities). They are faceless, mere characters. Can people be reduced to mere characters? Yes. Generally, yes. The creation of the individual is the UNIQUENESS. But when you characterize people in general terms, generally, they can be placed into the same bucket. So, can Governments. Forget the names. LOOK at what they ARE.
America has been Communized. They never had to fire a shot.
Did anyone take a vote on this? How was this even decided?
Senate? Congress? Nothing. This was done by EDICT !!!
Where’s the media? Who’s watching the government?
FDA Suddenly Bans Drugs That Have Been On The Market For Decades
March 24, 2011
from the perfect-gin-and-tonic-for-fun-and-profit dept
As Techdirt recently discussed, the drug pipeline is running dry, as Big Pharma’s patents are beginning to expire, and the drug companies are freaking out. For years they have beenspending more money on research and testing and getting fewer results. This year alone they are going to have 11 patents expire on drugs that bring in approximately $50 billion in revenue to the big pharma firms. Of course, the flip side to this is that consumers can start saving about 95% on the price of those drugs, as generics hit the market. The drug companies have gotten to a point where the incremental increases in efficiencies are so small as to be meaningless. What is coming is more personalized and targeted treatments for diseases — treatments that do not require bulk production of a specific chemical, but individual testing and personalized care, and not lifetime treatments and repeat sales, but cures. The treatments will be expensive to begin with, but they will become less expensive over time. The business model of healthcare is about to change dramatically, and Big Pharma needs to do something to maintain their profits. Unfortunately, they seem to have chosen the path of regulating the competition out of existence, rather than competing and innovating.
One way the drug companies have been coping is to repackage and rebrand health food supplements. Drugs like Lovaza, which is nothing more than the fish oil you can get in health food stores, and lovastatin which has been in use for roughly a thousand years (800 AD) in the form of red yeast rice. In the case of lovastatin, the FDA banned the supplementsbecause they are “identical to a drug and, thus, subject to regulation as a drug.” That is very convenient for the drug company, which now charges monopoly rents on the product — which can increase prices at ridiculous levels.
More recently, the FDA banned 500 prescription drugs that had been on the market and working for years. To be fair, it was really 50-100 drugs (pdf), made by different companies, but that just highlights how there was actual competition in the marketplace for these drugs, which has now been removed. For all of the drugs, there is either a high-priced prescription version, or all the small manufacturers have been removed, leaving a virtual monopoly for one or more larger companies. This process began in 2006 when the FDA decided to remove marketed unapproved drugs (pdf).
The reasoning is that these drugs weren’t ever technically “approved” by the FDA. While the FDA has been around for about a century, the business of having the FDA first approve drugs before they could go on the market came about closer to fifty years ago, and a bunch of “unapproved drugs” that were in common usage before that never got approved. The FDA is targeting many of those, even if they have a long history in the marketplace. Conveniently, of course, there always seems to be a pharma company with a monopolized substitute ready.
In 2006 the first “new” monopoly that was created by this FDA process was for the malaria drug quinine sulfate. This left only Mutual Pharmaceutical Company to manufacture quinine in the US (pdf). While malaria is not a disease that affects many people in the US, it is big business worldwide. Malaria causes 300 to 500 million infections and over 1 million deathseach year. Treating this disease with quinine used to cost pennies a day. In fact, the British turned this treatment into a cocktail, the gin and tonic (quinine water).
Another drug removed was the antihistamine carbinoxamine, which was created prior to needing FDA approval, in the early 1950s. It was approved by the FDA in a slightly modified form in 2006. It is now sold exclusively by Mikart, Inc and Pamlab, LLC with no future competition because the FDA has banned all 120 other versions of carbinoxamine. You can imagine just how much that must increase the profits for Mikart and Pamlab on carbinoxamine, though that seems to come at the expense of consumers.
It’s really nice being granted a government monopoly.
As for the drugs now being banned in this latest purge, you can argue that it’s not really 500 drugs, because many are different combinations of the same 50 to 100 drugs. To be sold, these disapproved drugs will require drug trials and certification — a massive and expensive process. Under current law, after successful completion of FDA trials these drugs will be granted approval. But in every case these trials are almost certainly not necessary. And, “coincidentally” in almost every case, there is a chemically similar patented version ready to go. This is a pure money grab: replacing old tried and true drugs, with monopoly priced prescription drugs. It just requires removing competing drugs from the market to increase profits.
And with that, I’m off to go have a gin and tonic, while it’s still legal…