You think....well, that stuff may be needed by my family some day only the costs for these procedures will remain high for decades according to changes in patent laws meant to protect brand names. I want to look at patent law today to show how Obama and Clinton neo-liberals are installing a very Republican policy of getting rid of public health and making health Wall Street profit-maximizing.
If you look at Affordable Care Act and then at Trans Pacific Trade Pact---two Clinton neo-liberal economic policies---you see the movement away from businesses making and selling generics----WHICH ARE THE PHARMA MOST PEOPLE CAN AFFORD---and moving towards brand name patent extensions especially in this biotech medical arena that only a few will afford. The biotech word for generic is
biosimilar----they are not the same.
Keep in mind that 'only slightly different' in medical chemistry can mean life or death. It is not a small matter.
What is the difference between a generic and a biosimilar?
- BioSimilars vs. Generic Drugs: What’s In a Word?
"How do biosimilars differ from so-called generic drugs? Generic drugs are essentially “copycat” versions of small molecule drugs – drugs that can be synthesized in the lab by following standardized, pre-defined procedures. Using well-established analytic techniques, the generic version of a small molecule drug can be demonstrated to be chemically and structurally identical to the innovator drug.
Biologic drugs, however, are much more complex than small molecule drugs. These drugs are proteins that must be produced by a living cell – they cannot be chemically synthesized in the lab by following a standard set of procedures. The cell makes these proteins by following a recipe provided by a short sequence of DNA – a gene – that is inserted into the cell. Here’s the catch: even if two different cells are provided the exact same recipe, the final product may be slightly different."
Clinton neo-liberals always posing progressive sold the ACA as good for seniors allowing more funding for generics and closing that donut hole. What the ACA actually does is push seniors to privatized Medicare Advantage to get those generic savings----allowing no such savings with public Medicare. At the same time they are sending seniors to private Medicare for drug affordability----they are making it harder and harder for any business thinking of manufacturing generic drugs----at the same time strengthening the patent rights to brand names. THIS WILL PLACE MOST PHARMA OUT OF THE REACH OF MOST SENIORS.
Remember, they are now selling US drugs to the world's rich--they don't need US seniors with cost-cutting on the mind.
What the ACA does is ensure that these new biotech patents will be the only PHARMA game in town and that they will retain profitability with longer patenting rights. No generics in this biotech world because---the whole point of biotech is BIOSIMILARS PATENTED EACH TIME AS A DIFFERENT BIOLOGICS.
I know this is all confusing for the lay-person---basically Clinton neo-liberals made sure that old-school PHARMA with all its generics will die----and new school biologics will live free to do anything for profit. People will access biologics in the trials/validation stage---but if proved safe----these prices will soar.
NEW PROCESS TO FIGHT CANCER THROUGH BIOLOGICS----THE AFFLUENT WILL HAVE ACCESS. MAIN STREET WILL BE PUSHED TO THE CHEAPEST TREATMENT---CHEMOTHERAPY FOR EXAMPLE.
When they use the phrase----'innovator drugs' in biologics----it means product mill as single changes to biologics create biosimilars----a new brand name product. By creating law that makes generics unlikely---product mill brand name products will soar.....each geared towards smaller groups.
Biotechnol Healthc. 2010 Winter; 7(4): 22–23. PMCID: PMC3008392
The Biosimilars Act: Promoting or Discouraging the Development of Generic Biologics?
A tug-of-war between generic and innovator biologics seems to be where drug developers are headed.
JOANNA T. BROUGHER, ESQ, MPHJoanna T. Brougher, Esq., MPH, is an intellectual-property consultant and adjunct lecturer on health policy and management at the Harvard School of Public Health.
Signed into law by President Obama on March 23, 2010, the Biosimilars Act is part of the health-care reform provisions included in the Patent Protection and Affordable Care Act. The act outlines the requirements for determining “bio-similarity” and “interchangeability,” provides the timeline for engaging in infringement, and sets forth the exclusivity period awarded to the innovator biologic as well as the first-filer biosimilar.
Like the Hatch-Waxman Act, the Biosimilars Act provides innovator biologics manufacturers with market exclusivity and delays market entry for manufacturers of generic biologics. Moreover, the act presents higher hurdles for manufacturers of generic biologics to overcome before they can enter the market, effectively delaying generic competition for a longer period of time. Rather than promoting the development of generic biologics, the Biosimilars Act may instead encourage the development of new innovative biologics.
Biologics are defined by the Public Health Service Act as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product.” Drugs, on the other hand, are defined as small-molecule compounds produced by purely chemical means.
Biologics are quickly gaining in the pharmaceutical market. Of the top 15 pharmaceuticals on the market in 2009, about one third are biologics. In 2008, biologics accounted for about 30 percent of sales of the top 100 pharmaceutical products, and by 2014 are expected to account for half of all pharmaceutical sales. Moreover, biologics are being approved by the U.S. Food and Drug Administration at a higher rate than are the so-called traditional, or small-molecule, drugs, suggesting that biologics may soon overtake them in the marketplace.
Despite the growth and success of biologics, manufacturers of generic biologics have struggled to enter the market. Biologics are more difficult to replicate because they are derived from living cells, and their molecules can be 100 to 1,000 times larger than traditional drugs. Moreover, the costs to develop the necessary manufacturing capacity are greater because of the complexity of biologics. In addition, the FDA approval process for biologics is longer, more complicated, and, therefore, more expensive.
The Biosimilars Act may present higher hurdles for manufacturers of biosimilars to overcome before entering the market, says Joanna T. Brougher, Esq., MPH.
Go to:Exclusivity period
One way that market entry for generics is delayed is by the market exclusivity period awarded to innovator biologics. Whereas the Hatch-Waxman Act provides innovator drugs with 5 years of market exclusivity, the Biosimilars Act provides innovator biologics with 12 years of market exclusivity.During this 12-year period, the FDA is prevented from granting final approval to a biosimilar that references the innovator’s biologic. As a result, generic biologics must wait longer before entering the market.
Generic biologics are further delayed by the exclusivity period awarded to the first approved generic biologic. Under Hatch-Waxman, a 180-day period of market exclusivity is awarded to the first approved generic drug applicant, after which time subsequent generic drugs can enter the market. Under the Biosimilars Act, the period of exclusivity depends on a number of factors and can range between 12 months and 42 months. In a basic scenario, for instance, the first generic biologic can have an exclusivity period of one year after commercial product launch. Only after that one-year period expires can any subsequent generic biologics be approved. In another scenario, approval of subsequent generics may be delayed by 18 months, which may occur when there is a final court decision or dismissal (with or without prejudice) on all patents-in-suit against the first approved generic biologic. In other words, if the first approved generic biologic and the innovator biologic engage in patent infringement, the innovator biologic may maintain market exclusivity throughout the duration of the infringement suit, and only upon a final court decision or dismissal can the first approved generic biologic be rewarded with 18 months of exclusivity. If the innovator biologic can prolong the duration of the infringement suit to at least 42 months, any subsequent generic biologic must wait 42 months after approval of the first generic biologic product.
In the event that the generic is not sued for infringement by the innovator, any subsequent generic biologics must again wait 18 months after approval of the first generic biologic. Under this scenario, the innovator and generic manufacturers may enter into a settlement agreement that would allow them to share the exclusivity period. Use of settlement agreements can occur because, unlike with Hatch-Waxman, patent litigation is not required under the Biosimilars Act — instead, negotiation is encouraged. As a result, the innovator manufacturer can avoid litigation and negotiate a settlement with the generic manufacturer, thereby obtaining an additional period of marketing exclusivity as the generic manufacturer markets the innovator’s product and pays royalties to the innovator. During this exclusivity period, the innovator can control the market, delaying generic biologics competition by up to 18 months.
Go to:Implications for the healthcare industry
The hurdles presented by the Biosimilars Act may have significant consequences for both healthcare providers and consumers. Such hurdles, coupled with the initial difficulty of copying biologics, may discourage biologics manufacturers from even developing a generic version. Instead, they may choose to develop and commercialize an innovator biologic, leaving the biologics industry with even fewer generic options.
One consequence of limited generic competition is high prices, which may, in turn, affect access to biologics — if there is no generic version of a particular biologic, patients will be faced with paying a higher price for the innovator biologic. If the price is prohibitively high, patients may even have to forgo that line of treatment altogether. The public’s health, accordingly, may be affected by the limited availability of generic options.
On the other hand, by potentially discouraging generic competition, the Biosimilars Act may encourage the development of new biologic products. Rather than assuming the time and costs of replicating biologics that are already on the market, manufacturers may be more willing to develop new products that target different diseases and different populations. As a result, treatment options for more diseases may become available.
The Biosimilars Act may be considered to be the biologic industry’s response to the Hatch-Waxman Act. Although the act provides an approval pathway for generic biologics similar to the approval pathway for generic drugs, it may also present higher hurdles for generic biologic manufacturers to overcome before entering the market. These hurdles may effectively delay generic competition for a longer period of time and instead encourage innovation and the development of new biologics.
IT'S NOT PUZZLING FOLKS----IT IS WHERE GLOBAL POLICY TAKES AMERICAN MEDICINE.
The generics we have always been able to afford are now becoming less affordable was Wall Street is geared towards getting rid of anything that tries to interfere with highest market price. Now, businesses that would have jumped into the generics manufacturing are being paid by PHARMA not to create generics. That was not allowed before these health care reforms.
Look at the last article to where Trans Pacific Trade Pact being pushed by Obama and Clinton neo-liberals in Congress writes policy that makes generics a thing of the past world-wide----that is free market, deregulated naked capitalism----
The goal of Affordable Care Act is having over 80% of Americans on preventative care only----so making old-school PHARMA unavailable and/or unaffordable will lower longevity for Americans very fast
--THE PHARMA WE WILL BE ABLE TO ACCESS IS THE PHARMA WE NEED TO SET ASIDE---LOTS OF PAIN MEDICATION---LOTS OF DEPRESSION MEDICATION----LOTS OF ANTIBIOTICS----NOT SO MUCH CHRONIC CARE/HOSPITAL PROCEDURE.
The rising cost of generic drugs is even puzzling experts
Ben Allen, witf news | 12.11.14
For decades, generic prescription drugs have been considered the bargains of the pharmaceutical world. An industry group says Americans have saved more than $1.5 trillion in the past 10 years on brand name drugs, thanks to generics. But in recent months, prices on some of the most popular drugs have soared, and experts are trying to figure out why.
Buying generic prescription drugs feels like trading on the stock market for Cory Minnick.
"Just seems to snowball every month, it gets worse and worse. You see stuff you used to buy for pennies for a hundred, and now you're paying $70 to $80 just to get it in," he says.
Minnick, pharmacy manager at Royer’s on Sharp Avenue in Ephrata, Lancaster County, says he’s constantly checking with his three wholesalers to see what it’s going to cost to get a drug in the hands of a customer.
The popular antibiotic doxycycline is used to treat common problems like urinary tract infections and pneumonia. It cost a mere $20 for a 500 pill supply in October 2013. Yet this past April, its price had hit more than $1,800. Don’t do the math on the percentage increase, it could get ugly.
By the way, doxycycline has been on the market for 40 plus years, and the formula hasn’t changed. So what’s going on here?
Drugs have "life cycles"
"These recent drug shortage and price hikes illustrate a third stage of the life cycle of a drug that we haven't really paid much attention to yet," says Jeremy Greene, a Johns Hopkins professor and author of Generics: the Unbranding of Modern Medicine.
"What happens when a drug is no longer particularly attractive to generic manufacturers? Or when the interests of the generic marketplace continue to go towards the second pipeline, the pipeline of drugs that are going off patent now and the drugs that have been off for patents for a while are no longer particularly attractive and get neglected," he says.
Greene says drugs used to have two cycles – the brand name stage, where the patent protects the work done by companies like Pfizer, and helps them recoup their investment in research.
But then the patent expires, and all manufacturers have a shot to make and sell the drug, ideally, at a much lower cost.
That what Ralph Neas, President of the Generic Pharmaceutical Association is focusing on.
"It may go up 50% or a 100%, whatever it might but you’re still in the pennies and sometimes you get up to a couple dollars. A very few number are more than that," says Neas.
Here’s what we know: In 2010, the average cost of one of the 50 most prescribed generics was $13. In 2013, it hit $62.
That data comes from Catamaran, which manages pharmacy benefits for 32 million people.
Why are prices rising?
A lot of theories are floating around, but the most prominent ones deal with raw material shortages and less competition.
"The generics industry has really consolidated quite a bit in few years into several large companies, so it's no longer accurate to call the generic drug industry little pharma, as opposed to big pharma of multinational brands," says Greene.
It's a common refrain heard in every industry – through consolidation, companies can make more money because they can keep overhead down. And Greene says manufacturer in the health care world act like any other out there – always looking out for their best interests.
Adds Neas: "Well the margins aren’t very good. Remember, they're selling them for pennies. it’s very different than the brand business. It’s a robust industry, it's a successful industry, it's benefitted not just hundreds of millions in America but around the world, but it's also a demanding business, and the margins are low."
With all this said, one thing needs to be said – few are really noticing a change in what they pay.
That’s for two reasons: it’s virtually unheard of for insurance companies to adjust prescription drug copays in the middle of a year, and some of the increases may be built into monthly premiums for the whole system. That means even if you never get doxycycline, you still may be sharing in part of the increase.
It may not be long before plans start to adjust, says Sumit Dutta, the Chief Medical Officer at Catamaran, the pharmacy benefits manager.
"Now we may see two tiers, one for low cost generics, one for high cost generics, so that consumers can become aware of some of the drugs that may be hundreds, if not thousands, of dollars for a generic versus the ones that are less than $15 for a generic," says Dutta.
And that’s where the hit to the wallet could come.
At Royer’s in Ephrata, Cory Minnick is left to call for Congress to get involved, as much as he doesn’t like how that sounds.
"I don’t see an end game. It seems as though the manufacturers right now know what they'll be able to charge," says Minnick
"It almost, I don't want to call it collusion, but it almost seems like collusion because one of the manufacturers will raise their price, and sure enough, two days later, they're all up there at the same range, and certainly their manufacturing costs haven't increased that much in the same amount of time."
The federal government is also curious as well – the Department of Justice has subpoenaed generic manufacturers to get information on their dealings with competitors.
As for relief from the price hikes on pills that have been around for decades, well, the only answer right now is to swallow them.
One way to 'close the donut hole' is to end Federal Medicare and make it too expensive for seniors to access PHARMA-----that is how a Clinton Wall Street neo-liberal thinks.
Intellectual property is big in TPP and it includes all this biologic technology. TPP seeks to make sure nations aren't setting up generic mills as India did with old-school PHARMA.
How does all this relate to medical microchips? The goal of corporations seeking profit will be to use the American people during the development stages in lieu of clinical trials and then allow costs to soar once a drug or biologic seems safe enough. That's where main street access to these designer products will start and end. As with the J-CHIP technology I shared yesterday-----FIRST HUMAN TESTING IN 2012-----we already know they are creating a tiered health system that does not shy away from using American citizens as research patients just as has happened overseas for decades.
ALL OF THE CONSTITUTIONAL PROTECTIONS AND REGULATIONS THAT HAVE MADE AMERICA ONE OF THE BEST AND SAFEST IN THE WORLD IS BEING DISMANTLED.
Add to that the drive to sell their own patented products-----Johns Hopkins and UMMS are great big biologic product patent mills-------and health systems will be fleecing Medicare and Medicaid for what has always been Research and Development under clinical trials to subsidize this research even more. We are assured by FDA leader who is a corporate executive that FDA has a strong approval process and yet-----we see medical/PHARMA class action cases soaring from BAD MEDICINE.
All of this incentive towards getting innovative product to market combined with gutting of funding for staff, quality control, and oversight will take an already compromised health system to a dangerous level as they try to install technology that makes all this error increasingly likely. People may not be fearful of these new technologies----they are about how fast this is happening with a breakdown in regulations that protect.
Medical Errors Harm Huge Number of Patients
What will it take to make America’s hospitals safer?
By Steve Sternberg Aug. 28, 2012 | 5:25 p.m. EDT
Critics Question FDA's Approval Of Zohydro
February 26, 2014 5:00 AM ET Laura Sullivan NPR
How TPP Would Harm You At the Drug Store and On The Internet
February 24, 2014 Campaign For America's Future.
Intellectual Property and Drug Prices
One example of the way the intellectual property provisions favor giant, multinational corporations over smaller, innovative corporations and regular people around the world is in pharmaceutical prices.
A company with a drug patent is granted a monopoly to sell the drug at any price they choose with no competition. Currently a drug might be patented for a limited number of years in different countries. When the patent runs out other companies are able to manufacture the drug and the competition means the drug will sell at a lower cost.
Leaked documents appear to show that TPP will extend patent terms for drugs. Countries signing the agreement will scrap their own IP rules and instead follow those in TPP. So giant drug companies will have the same patent in all countries, for a longer period, and the patent will prevent competition that lowers drug prices.
Currently smaller, innovative companies can produce “generic” drugs after patents run out. Because of competition these drugs can be very inexpensive. Walmart, for example, sells a month’s supply of many generic drugs for $4, while drugs still under patent protection can cost hundreds or even thousands. This is of particular concern to poor countries that will be under TPP rules.
Please read Expose The TPP‘s section The Trans-Pacific Partnership and Public Health, which begins:
The TPP would provide large pharmaceutical firms with new rights and powers to increase medicine prices and limit consumers’ access to cheaper generic drugs. This would include extensions of monopoly drug patents that would allow drug companies to raise prices for more medicines and even allow monopoly rights over surgical procedures. For people in the developing countries involved in TPP, these rules could be deadly – denying consumers access to HIV-AIDS, tuberculosis and cancer drugs.