Posted on 04/07/2016 7:00:57 AM PDT by Kaslin
Last week, presidential candidate Senator Bernie Sanders joined 11 other members of Congress in sending a letter to the National Institute of Health (NIH), urging the agency to cut costs for the prostate cancer drug, Xtandi, by employing its “march-in rights.” These rights, which have never before been utilized by the NIH, were established in 1980 under the Bayh-Dole Act, which gives federal agencies the authority to license a patent when action is deemed necessary, primarily as an emergency tactic. Using this provision as their justification, lawmakers are requesting that NIH override Xtandi’s patent protection, which guarantees its manufacturers exclusive sales, in an effort to reduce the costs of the drug.
This request represents an enormous overreach by the government into U.S business and a major threat to the drug development process as a whole. However, Senator Sanders’ proposal doesn’t just have the potential to undermine the drug development system, it also poses a serious danger to the patent system by allowing the government to intervene in the protection of intellectual property.
The Constitution gives Congress the power to grant patents under Article I, Section 8, Clause 8. The establishment of patents is a key constitutional right and critical to fostering American innovation and growth for well over two centuries. Like the property rights our founding fathers valued in the highest degree, the protection of intellectual property has been key to America’s success, responsible for establishing us as a global leader across many industries. Undermining the patent system, even for just one patent in one industry, would call into question our nation’s entire system for protecting intellectual property and undercut a core American value that sets us apart from other nations.
Encouraging NIH to utilize their “march-in rights” threatens all of this and although Senator Sanders’ letter focuses on the biopharmaceutical industry, it’s not just one industry that should be concerned. Having federal agencies intervene in patents, as Senator Sanders would like, sets a dangerous precedent of government overreach into the free market. Furthermore, what he is suggesting is a complete re-interpretation of legislation. The Bayh-Doyle Act was adopted to assist in the manufacturing of products to meet need during health or other public emergencies. In 35 years, these rights have yet to be deemed necessary by the NIH.
Patents are critical for any industry (or innovator) that takes risks to develop better products that move us forward and the biopharmaceutical industry is no exception. Biopharmaceutical companies operate under a complex business model-balancing the needs of patients, the demands of investors, and the hefty regulations imposed by the government. In order to encourage the development of innovative drugs (like Xtandi), the industry relies on patent protections to justify their investments. Allowing the government to step in and alter this system would most certainly have dire consequences-namely, new drugs might not be developed.
In their letter, lawmakers requested NIH hold a public hearing to override Xtandi’s patent, which they believe would lower the cost of the medication. What they fail to realize, however, is that in their attempt to improve access to life-saving medications like Xtandi they are actually threatening the future of innovative medicines. If investors know that patents are no longer protected and returns will be limited, the incentive to fund critical research and develop new treatments will plummet. If we want to continue to see progress in medicine, or in any industry for that matter, we can’t let the government interfere in patent protections.
Attacks like this on individual drugs and their manufacturers won’t fix the systematic problem of rising healthcare costs in our country, in which insurers, hospitals, and healthcare providers all play a role. Targeting Xtandi individually and asking for more government intervention is not only a clear political move by Senator Sanders that won’t actually improve access to medicines for Americans, but a play that will also dismantle the entire patent system that protects U.S. innovation and specifically the development of effective treatments. With innovators on the cusp of major advances in disease areas like cancer, diabetes, and Alzheimer’s we need to be looking towards reforms that encourage drug development and accessibility, not misguided proposals that propel unnecessary and unwarranted government overreach in the healthcare market and everywhere else.
Unconstitutional..................
Unfortunately, price controls, in whatever form, will be necessary for medicines. While the drug companies may be entitled to $50.00 per pill they are NOT entitled to $750.00 per pill.
they pushed gabapentin for a million off label uses, even though most docs say it’s basically a placebo.
I have read a lot about its mechanism as compared to benzos and the benzos win out every time, regarding anxiety.
As for pain, though I think it was WAY overprescribed, oxy is miles ahead of gabapentin in controlling pain. BTW, big pharma PROMISED they would never push oxy for anything other than cancer.
But we knew that was a lie.
Now that millions are addicted, they come out with suboxone to treat the addictions. Can’t lose that way!!
The only thing that helps my head injury symptoms is klonopin.
Gabapentin, lyrica, and a billion other pills that wer supposed to help did nothing.
Since when has that mattered. 99% of the crap they do is unconstitutional.
What does the amount that the pill is being sold for have to do with the right of ownership?
CC
What does the amount that the pill is being sold for have to do with the right of ownership?
CC
We don’t have health care.
Too many people aren’t healthy.
All we have is “death delaying”.
Last time I checked, everyone dies. Its just a question of how much money other people are forced to fork over to delay someone else’s death.
From my perspective, I have pretty much nothing saved up for retirement, so why the f#*$ should I pay for someone else’s “health care”?
My retirement plan involves a cinderblock, handcuffs, and the reservoir. When I can’t work anymore, I will put both hands through the cinderblock, snap on the handcuffs, and step off into the reservoir or the (water-filled) quarry. Simple, and neat. (and full-proof)
Hhmmmm...our old dog is on Gabapentin. ..among others....been wondering whether it does any good. I hate that the solution to most physical problems is DRUGS.
Why do you believe that the pharmaceutical companies should not be able to set their own prices? I also note that you use the loaded term “entitled”, as opposed to the more frank term “deserve”, which is what you mean.
Leftists just do not understand that financial incentive is what drives creation & production of EVERYTHING. Take away the incentive for profit, and the motivation to create & produce evaporates (not entirely, but certainly at large scale). Yes, those medicines are expensive and the manufacturer is making a large profit at the probable expense of patients’ ability to afford them ... but if not for that large profit, there would be no incentive to create such medicines in the first place.
Amid the Left’s fondness for “redistribution of wealth” and “soak the rich” and “consequence-free sex” etc, they fail to see what ISN’T created as a result. They want to optimize what is (to their own flippant preferences), not realizing that in doing so, what is soon becomes replaced by isn’t.
Greedy rich? redistribute! ... why aren’t the productive, well, productive any more?
Consequences to carnal acts? control/abort! ... why is the population shrinking, and the tax base with it?
Medical costs too high? cut their profits! ... why aren’t lifesaving advances progressing?
Idiots. Think “value” just grows on unwatered trees.
Three conditions for a free market long known by economists:
In the American healthcare system all three principles are violated in spades.
Without that $750, they won’t have the incentive (or money) for another $2,000,000,000 in R&D for the next drug.
Hard to quibble about the price of a lifesaving drug that DOESN’T EXIST BECAUSE YOU DISCOURAGED ITS CREATION.
This is what PhRMA lobbied for, to give the government control over the industry so that they could leverage monopoly pricing power. They spent tens if not hundreds of millions lobbying for just that - and reaped enormous ill-gotten profits as a result.
The bird has flown, ship sailed, horse left the barn. Sanders’ proposal on one drug is completely insignificant in light of ACA, and Medicare Part D before that.
I’m sorry. It does NO HARM. Most harmless drug on the market, I think. So I would keep him no it, poor fella. What’s wrong with him/her?
I’ve taken maybe 30,000 pills in my life. Mom was hypochondriac nurse and when pop, who was on a lot of pills, died, she transferred them to me lol.
I probably need 200 my whole life, besides the klonopin, to treat infections etc.
Big pharma made a monkey out of me.
You go to CVS to get blood pressure, cholesterol and heart and diabetes meds and five feet from the counter are six aisles of the worst foods imaginable! lol
But no tobacco allowed!!!
> I hate that the solution to most physical problems is DRUGS.
It isn’t. The pharmaceutical culture really doesn’t solve too many health problems, it just puts people on drugs forever.
There’s no profit in a cheap cure, and thanks to the actions of the industry the government would come down like a hammer on anyone who discovered one that undermined a PhRMA profit center.
If someone developed a $1 pill that would cure cancer, do you think it would ever see the light of day?
Because the $750.00 per pill is not paid for with private money. It is taxpayer money. If they had to rely upon what folks would willingly pay out of their own private pockets they would not get $750 per pill or any sizeable fraction thereof.
May those who believe in the ridiculous concept of “Free Market,” need with regard to medications required for their sick child, a drug that moves in price from 50.00 to $750.00 per dose. Ownership cannot be used to injure others and that is a doctrine that is a thousand years old.
She is losing muscle mass, has slow growing cancer, and pain...she’s getting acupuncture too...lol...she’s our last dog...and...she’s old...15.5...but still gets excited about eating and walking.
.so she’s not ready for doggie heaven, yet.
You are correct...”solution” was wrong word...
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