from the dishonor-on-you,-dishonor-on-your-cow dept.
Submitted via IRC for Runaway1956
Update 5/17/2018: The FDA has now launched the website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives. You can view the list here. It includes notable medications, such as Accutane (for acne), Methadone (used for opioid dependency), and Tracleer (to treat high blood pressure in the lungs). The brand name drug makers to be shamed includes big hitters such as Celgene Corp, GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, Gilead Sciences Inc, and Actelion Pharmaceuticals Ltd, now a Johnson & Johnson company. Our original story, published May 16, is unedited below.
The Food and Drug Administration plans this week to effectively begin publicly shaming brand-name drug companies that stand in the way of competitors trying to develop cheaper generic drugs.
FDA Commissioner Scott Gottlieb told reporters on Monday and Tuesday that the agency will unveil a website on Thursday, May 17 that names names of such companies. More specifically, the website will publicly reveal the identity of 50 branded drugs and their makers that have blocked generic development. The website will also be updated "on a continuous basis" to list additional names.
In fielding questions from reporters, Gottlieb denied that the effort was a form of public shaming. "I don't think this is publicly shaming," Gottlieb said, according to S&P Global Market Intelligence. "I think this is providing transparency in situations where we see certain obstacles to timely generic entry."
Related Stories
Health systems representing around 500 U.S. hospitals have formed a not-for-profit pharmaceutical manufacturer called Civica Rx. The drugs will be cheap, and the CEO will not receive a paycheck:
A drugmaking venture backed by major U.S. hospitals has picked a chief executive officer, hastening the arrival of another threat to generic pharmaceutical manufacturers.
Martin VanTrieste, 58 and a former top executive at biotechnology giant Amgen Inc., will run the organization, a not-for-profit called Civica Rx. Dan Liljenquist, 44 and an Intermountain Healthcare executive, will be chairman. Health systems with a total of about 500 hospitals -- including Intermountain, HCA Healthcare Inc., Mayo Clinic and Catholic Health Initiatives -- will help govern the venture, alongside several philanthropies.
Civica Rx will work to combat drug shortages and skyrocketing prices for some treatments given in hospitals by manufacturing generics or contracting with other firms to make them. Generic drugmakers have faced scrutiny for raising the prices of certain older drugs, particularly when hospitals lack alternatives. The supply chain for such treatments has also been vulnerable to disruptions, leading to persistent shortages.
"Civica Rx will first seek to stabilize the supply of essential generic medications administered in hospitals," the group said in a statement. "The initiative will also result in lower costs and more predictable supplies of essential generic medicines."
The venture, announced by Intermountain in January, said it plans to have its first products ready by as early as next year. It's focused on a group of 14 drugs given in hospitals, but a spokesman for the group declined to identify them. Liljenquist said that the drugs are in categories such as pain relief, antipsychotics, antibiotics and cardiovascular treatments, including drugs that are stocked on so-called crash carts used in emergencies.
Also at NPR, CNBC, The Washington Post, and Forbes.
Related: The Cheerios Theory of Branded Medicine
Mylan Overcharged U.S. Government on EpiPens
Martin Shkreli Points Fingers at Other Pharmaceutical Companies
Amazon, Berkshire Hathaway, and JPMorgan Chase to Offer Their Own Health Care to U.S. Employees
Analysts Question Whether Curing Patients is a Sustainable Business Model
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
Martin Shkreli continues to run business from prison, report says
Martin Shkreli reportedly runs his pharmaceutical company from prison on a contraband smartphone. Shkreli continues to run the remains of the drug company that once earned him the title of most hated man in America, according to a story in the Wall Street Journal. He was convicted of securities fraud and conspiracy in 2017. He has served 16 months of a seven-year sentence in federal prison.
Shkreli is reportedly running Phoenixus AG, formerly known as Turing Pharmaceuticals. In 2015, when Shkreli was the CEO, Turing raised the price of the lifesaving drug Daraprim used by AIDS patients from $13.50 a pill to $750 a pill. The price hike sparked a public outcry.
The Journal says that Shkreli anticipates the company will grow more successful while he's in prison. He believes the company, of which he owns 40%, could be worth $3.7 billion by the time he gets out of prison.
On one recent phone call, Shkreli fired Phoenixus CEO Kevin Mulleady, the Journal reported. Shkreli reportedly later changed his mind, agreeing to suspend Mulleady rather than fire him.
Cartoon villain performance art.
Previously: Martin Shkreli Points Fingers at Other Pharmaceutical Companies
Martin Shkreli Convicted of Securities Fraud Charges, Optimistic About Sentencing
Martin Shkreli Lists Unreleased Wu-Tang Clan Album on eBay
Martin Shkreli's $5 Million Bail Revoked for Facebook Post Seeking Hillary Clinton's Hair
Sobbing Martin Shkreli Sentenced to 7 Years in Prison for Defrauding Investors
Related: Drug Firm Offers $1 Version of $750 Turing Pharmaceuticals Pill
Mylan Overcharged U.S. Government on EpiPens
EpiPen Maker is Facing Shareholder Backlash
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company
Scott Gottlieb walks through the revolving door to the Pfizer board
The revolving door turns again. After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world's largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines.
And in doing so, Gottlieb is also picking up where he left before joining the agency, since he had been on the board of several smaller pharmaceutical companies and was also a partner at a venture capital firm that invests in life sciences companies.
"This is classic and it's not surprising," said Sidney Wolfe, a founder of Public Citizen Health Research Group and a long-time FDA watchdog, who had expressed concern about Gottlieb's ties to industry before joining the agency. "Philosophically, he's returning to the ecosystem where he's most comfortable. And he'll get paid very well for it, too."
Also at Financial Times.
Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Drug Approvals Sped Up in 2017
Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation
FDA Labels Kratom an Opioid
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated] (including Pfizer)
U.S. to Make More Drugs Easily Available, Cutting Role Docs Play
Infamous ex-pharmaceutical executive Martin Shkreli is yet again in trouble with the Federal Trade Commission, which announced today that the convicted fraudster has failed to cooperate with the commission's investigation into whether he violated his lifetime ban from the pharmaceutical industry by starting a company last year called "Druglike, Inc."
[...]
At the center of the dispute is whether Shkreli's co-founding of Druglike runs afoul of his lifetime ban from the pharmaceutical industry, which was in response to Shkreli's infamous move to raise the price of the cheap, life-saving anti-parasitic drug, Daraprim, from $17.50 a pill to $750 a pill in 2015.
[...]
The FTC also noted in its court filing that Shkreli has so far failed to pay any of the $64.6 million in disgorgement he was ordered to pay alongside his lifetime ban.
Previously:
Martin Shkreli Launches Blockchain-Based Drug Discovery Platform
Martin Shkreli Accused of Running Business From Prison With a Smuggled Smartphone
Sobbing Martin Shkreli Sentenced to 7 Years in Prison for Defrauding Investors
Martin Shkreli's $5 Million Bail Revoked for Facebook Post Seeking Hillary Clinton's Hair
Martin Shkreli Lists Unreleased Wu-Tang Clan Album on eBay
Martin Shkreli Convicted of Securities Fraud Charges, Optimistic About Sentencing
Martin Shkreli Points Fingers at Other Pharmaceutical Companies
Related:
U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
EpiPen Maker is Facing Shareholder Backlash
Mylan Overcharged U.S. Government on EpiPens
Drug Firm Offers $1 Version of $750 Turing Pharmaceuticals Pill
In an effort to avoid being held in contempt of court, former pharmaceutical executive and convicted fraudster Martin Shkreli made an eyebrow-raising argument to a federal judge Friday, stating that his company Druglike, which he previously described as a "drug discovery software platform," was not engaged in drug discovery. As such, he argued he is not in violation of his sweeping lifetime ban from the pharmaceutical industry.
Last month, the Federal Trade Commission and seven states urged a federal judge in New York to hold Shkreli in contempt for allegedly failing to cooperate with an investigation into whether he violated the ban. The FTC said Shkreli failed to turn over requested documents related to Druglike and sit for an interview on the matter.
In the filing Friday, Shkreli claims that he responded to the FTC's requests "promptly and in good faith."
Previously:
FTC: Shkreli May Have Violated Lifetime Pharma Ban, Should be Held in Contempt
Martin Shkreli Launches Blockchain-Based Drug Discovery Platform
Shkreli Released From Prison to Halfway House After Serving <5 of 7 Years
Martin Shkreli Accused of Running Business From Prison With a Smuggled Smartphone
Sobbing Martin Shkreli Sentenced to 7 Years in Prison for Defrauding Investors
Martin Shkreli's $5 Million Bail Revoked for Facebook Post Seeking Hillary Clinton's Hair
Martin Shkreli Lists Unreleased Wu-Tang Clan Album on eBay
Martin Shkreli Convicted of Securities Fraud Charges, Optimistic About Sentencing
Martin Shkreli Points Fingers at Other Pharmaceutical Companies
Related:
"Pure and Deadly Greed": Lawmakers Slam Pfizer's 400% Price Hike on COVID Shots
U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
EpiPen Maker is Facing Shareholder Backlash
Mylan Overcharged U.S. Government on EpiPens
Drug Firm Offers $1 Version of $750 Turing Pharmaceuticals Pill
(Score: 2) by JoeMerchant on Sunday May 20 2018, @01:33AM (2 children)
Unfortunately, transparency often has the effect of publicly shaming entities with lots of focused power (money) that are taking advantage of less focused less powerful entities (usually ordinary people)... so why would the powerful encourage, or even allow it?
🌻🌻 [google.com]
(Score: 2) by driverless on Monday May 21 2018, @01:52AM (1 child)
It also, unfortunately, will have zero effect on the named corporations. Their business model is fairly close to corporate psychopathy, being named as immoral won't affect them one bit, that's their business model. Their investors may even reward them for it, because what they're doing maximise profits compared to allowing competing generics.
(Score: 2) by JoeMerchant on Monday May 21 2018, @03:08AM
It _could_ be the start of a political movement for legislation to speed generics to market... I'm probably too old to see that happen in my lifetime (said my 14 year old son.)
🌻🌻 [google.com]
(Score: 5, Interesting) by MichaelDavidCrawford on Sunday May 20 2018, @01:45AM (4 children)
My pdoc gave me the fantastically expensive Latuda for depression. It didn't do squat
But amitryptiline has been generic for generations yet works really well
But no one promotes it to doctors
Yes I Have No Bananas. [gofundme.com]
(Score: 1, Informative) by Anonymous Coward on Sunday May 20 2018, @02:40AM (3 children)
What generic drug makers don't tell you, but a good doctor will... "A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name." So you might be under dosed or over dosed with Generics.
(Score: 4, Informative) by Anonymous Coward on Sunday May 20 2018, @04:58AM (2 children)
That is actually a common misconception. The bounds of the 90% confidence interval of bioequivalence must be within those two limits. This does not mean that the actual drug concentration will actually be anywhere near those limits. The real difference is (usually) in the secondary effects of inactive ingredients and manufacture processes affecting the amount of time it takes to become bioavailable (the AUC) and the exact duration of said bioavailability. The different inactive ingredients and processes can also cause people to have different side-effects and contraindications for the generic.
(Score: 2) by arslan on Sunday May 20 2018, @11:06PM (1 child)
So what does all that mean to the lay-men? Here in oz, we're told, by the pharmacist at least, that generics and branded drugs have no difference apart from price..
(Score: 0) by Anonymous Coward on Monday May 21 2018, @01:34AM
First I want to clarify something. Latuda and amitryptiline are two different drugs. What MDC is talking about is not a difference of generic vs branded effectiveness.
As for your question, when it comes to treating your condition, there is no real difference between generics and branded. Generics are just as safe and effective as branded drugs in every real sense. The difference comes in two places. The first is when the drug reaches dosing level in your blood, which can vary depending on the exact formulation and cannot be more than a few percentage points from the branded drug. For standard ingested drugs, the difference is literally seconds. However, that can cause people to have placebo reactions that magnify the actual difference. The second is side effects. Generics can have different side effects from their branded counterparts because the INACTIVE ingredients can be different. Usually they just use cheaper fillers (AKA bulking agents) but other excipients can be changed as well (as long as it doesn't affect the AUC/timing too much). Again, even slight changes in side effects can be magnified by the placebo effect, but if you check the inserts, they are usually minor (think slight indigestion). Really, the only time you need to be extra careful is when you switch between drugs, e.g. branded to generic, generic to generic, or generic to branded.
A good video on the subject is here: https://www.youtube.com/watch?v=vqXrfzWgDkE [youtube.com]
(Score: 1, Interesting) by Anonymous Coward on Sunday May 20 2018, @01:48AM (11 children)
As someone with an incurable medical condition, I hope the pharma companies make lots of money. They are sure to invest some of it in research, which is the only hope that some of us have. Don't want to pay so much for acne medicine? So don't. It won't kill you.
(Score: 2, Insightful) by Runaway1956 on Sunday May 20 2018, @01:51AM (2 children)
Sounds like a shill? Smells like a shill? It's probably a shill.
(Score: 2) by bzipitidoo on Sunday May 20 2018, @04:46PM (1 child)
Sounds like sarcasm to me.
(Score: 2) by BK on Sunday May 20 2018, @05:15PM
But they forgot to set the sarcasm bit, or to use a sarcasm font, or even the sarcasm tag. Kids these days...
...but you HAVE heard of me.
(Score: 0) by Anonymous Coward on Sunday May 20 2018, @02:47AM
s/acne/AIDS/ (commenting for Mr. Shkreli while he's AFK)
(Score: 5, Informative) by MostCynical on Sunday May 20 2018, @02:48AM (2 children)
Your faith in pharmaceutical companies even wanting to invest in *cures*, let alone bother if they obscure, rare diseases, is... delusional.
Unless your incurable condition is "stupidity", or "delusional optimism".
"I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
(Score: 0) by Anonymous Coward on Sunday May 20 2018, @05:14AM (1 child)
Why would a pharma company want to kill off the cash cow that brings its insurance card to the pharmacy register monthly?
Everything is going to a rent-seeking subscription base these days... including life itself. Usually monthly.
( You can't even buy a can of beer these days... you can only rent it for an hour or so! )
(Score: 1) by khallow on Sunday May 20 2018, @12:50PM
(Score: 2) by crafoo on Sunday May 20 2018, @07:51AM (3 children)
Ironically, actually taking that particular acne medicine may kill you. It's one of the side effects. Of course they say it's rare, but once you personally know someone who's died from it.. well, death seems like a somewhat absurd side effect for acne medicine.
(Score: 5, Interesting) by bzipitidoo on Sunday May 20 2018, @12:55PM (2 children)
And there is a much, much better way to deal with acne: cut back on sugar. If you do have something sugary, in enough quantity that plaque rapidly builds up in your mouth, brush your teeth and tongue afterwards. I have also found that brushing my teeth can help curb cravings for sweets. Maybe the sugar loving bacteria in the mouth are able to influence their hosts to crave more sugar?
Big Pharma neglects to tell people stuff like that. I've concluded that capitalism has seriously warped our health care. Money is first. Patients are definitely secondary to money. That's why there's much more focus on treatments than cures, and all the myriad other tricks they pull to increase their profits at our expense, you know, expiration dates on medicine that are way too soon, the whole idea of marketing drugs directly to patients, bribing doctors, trying to scare people away from generics and Canadian drugs by slyly implying their quality is suspect, doing a little regulatory capture, and so on.
(Score: 2) by termigator on Sunday May 20 2018, @04:23PM
Also look at diet and the possibility of an allergy to what you eat.
I have a relative that had blood test showing they have an allergy to dairy. Once they stopped consuming dairy, their acne went away.
(Score: 2) by Mykl on Monday May 21 2018, @02:40AM
I had teenage acne until I stopped using soap on my face. As soon as I changed that (use soap on the rest of the body, just not the face), everything cleared up.
Probably not a cure for seriously bad acne, but for the standard-grade teenage type, it worked for me.
(Score: 0, Redundant) by khallow on Sunday May 20 2018, @02:05AM (15 children)
I'm underwhelmed by this. So companies are expected to voluntarily cooperate with competitors in order to undermine their own business? I get that the US drug market is ridiculously broken. But naive approaches like this are an embarrassment. I predict here that the billions of dollars per year in profits from continued inhibiting of generic drug competitors will buy a lot of apathetic, passive-aggressiveness from the guilty culprits even with this attempt at shaming.
(Score: 2) by Whoever on Sunday May 20 2018, @02:40AM (1 child)
That's because this is pure theatre. The administration think that Trump supporters will think he is doing a good job because of this, while the pharma companies have shown time and time again that they don't care about their image.
You should be underwhelmed.
(Score: 1, Funny) by Anonymous Coward on Sunday May 20 2018, @05:21AM
One would hope that Trump is about to show big pharma experience what negotiation is like with a sociopath negotiating for the American people.
One would expect that you are correct. It's pure theater to distract from passing more legislation for ensuring big pharma continues to set record profits.
(Score: 3, Insightful) by deimtee on Sunday May 20 2018, @03:20AM (6 children)
How about, if you want government-backed patent protection, you pay the price. And that price includes samples and disclosure of production methods.
Using patents and then pretending that the medical industry is a free market is laughable.
If you cough while drinking cheap red wine it really cleans out your sinuses.
(Score: 1) by khallow on Sunday May 20 2018, @03:50AM (5 children)
And pray they don't alter the deal further?
(Score: 4, Insightful) by deimtee on Sunday May 20 2018, @04:00AM (4 children)
The deal is you disclose your invention and the Government will enforce a monopoly on your behalf for an agreed time. After that time it is free for everyone to use.
Who is not living up to that deal?
If you cough while drinking cheap red wine it really cleans out your sinuses.
(Score: 1) by khallow on Sunday May 20 2018, @04:05AM
Both parties are living up to that deal. Just because something becomes free to use doesn't imply any obligation to help others figure out how to use it. The generics aren't under any obligation to reveal their trade secrets either.
(Score: 1, Interesting) by Anonymous Coward on Sunday May 20 2018, @05:26AM (2 children)
You're barking up the wrong tree. Many medicines that have been in the headlines for obscene prices are not under patent monopoly.
The problem is barrier of entry for independent manufacture of these medicines.
We need to reduce the barrier of entry for companies to add new generics to their brand. The free market is a valid solution for the scope of this particular problem.
There are many, many other problems with the price of healthcare in general, some/many of which the free market is unable to solve.
(Score: 3, Insightful) by Jiro on Sunday May 20 2018, @08:27AM (1 child)
There is no free market here. The competitor is not permitted to produce the generic until he does tests that require samples of the first company's product. If there was a free market, the competitor wouldn't need permission--they'd just do it. And if there was a free market, the first company wouldn't be the only source of samples anyway, since the fact that it is the only source of samples depends on the government-granted patent monopoly it had during previous years.
(Score: 1) by anubi on Sunday May 20 2018, @12:23PM
Yup, kill off the "artificial monopoly: legal extortion crafted by Congress", and stuff like this will be like going to the dollar store for a bottle of aspirin. I am quite happy my doctor finds quite cheap generics for what ails me. So far, everything has done what needed to be done.
My best take on this whole mess is that pharmaceuticals, like software, changes for increased profitability, with efficacy taking a distant back seat.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 0) by Anonymous Coward on Sunday May 20 2018, @05:07AM
The generic company needs to prove equivalence. They therefore need samples.
I suppose there is another solution to this. Cough up the samples, or we waive the requirement to prove equivalence.
(Score: 2, Flamebait) by frojack on Sunday May 20 2018, @06:27AM (4 children)
I didn't find the story, or the methods convincing.
An FDA doctor writes a prescription, and a generic company obtains the samples from a retail pharmacy.
There are enough exemptions in the law to allow this without the manufacturer ever knowing about it once the patents expire.
I don't believe EITHER of the two tactics are actually any impediment to obtaining samples.
I have heard of some manufacturers coming out with new patented versions, sometimes with a simple change in a non-active ingrediant, sufficiently ahead of the old patent expiration so that all of the old product will be gone from the supply chain before the patent expires. Then they could refuse to restart the manufacturer of the old product to supply samples.
But seriously, obtaining samples isn't that hard.
No, you are mistaken. I've always had this sig.
(Score: 2) by Jiro on Sunday May 20 2018, @08:31AM (2 children)
I would be very surprised if the FDA permitted illegally-obtained samples to be used in testing. I would also be very surprised if a doctor who tried this didn't get reported to the medical board and punished, if the company ever finds out about it. (And I doubt the required number of samples is small enough that one physician could get them anyway.)
(Score: 1) by khallow on Sunday May 20 2018, @11:43AM (1 child)
Why would you use such samples in testing? Those are merely to determine what additives are included with the active ingredients.
(Score: 1) by khallow on Sunday May 20 2018, @12:54PM
(Score: 3, Informative) by Whoever on Sunday May 20 2018, @04:01PM
Once again, you are writing from the perspective of ignorance.
There is a good article on the topic here:
https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive [hbr.org]
They also use captive pharmacies to limit supplies of their drugs to patients only (thus preventing equivalence testing).
(Score: 5, Interesting) by realDonaldTrump on Sunday May 20 2018, @02:13AM (6 children)
The middlemen became very, very rich. My administration is launching the most sweeping action in history to lower the price of prescription drugs for the American people. I call it American Patients First. We will have tougher negotiation, more competition and much lower prices at the pharmacy counter. And it will start to take effect very soon. America will not be cheated any longer and especially will not be cheated by FOREIGN COUNTRIES. It's unfair, it's ridiculous and it's not going to happen any longer. We will work every day to ensure all Americans have access to the quality, affordable medication they need and they deserve. And we will not rest until this job of unfair pricing is a total victory for the USA. It will happen and it's going to happen quickly. The American people deserve a health care system that takes care of them, not one that taxes and takes advantage of our patients, our consumers and our citizens. Time to derail the gravy train! hhs.gov/sites/default/files/AmericanPatientsFirst.pdf [hhs.gov]
(Score: 3, Funny) by Gaaark on Sunday May 20 2018, @02:30AM (2 children)
What? Like,......what the what???
Why the fuck am I thinking you're doing another good thing?!?!?!
Holy fuck, what?
My brain is 'sploding!!!!!!
What the smoked mackerel is going the feck on????????!
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 2) by realDonaldTrump on Sunday May 20 2018, @08:13PM (1 child)
Foreign Countries are forcing our terrific pharma industry to sell drugs VERY CHEAPLY. So the prices in the USA go sky-high. I'm calling on those Countries to end the price controls. So prices in America will come down to what folks can afford. America First!!!
(Score: 3, Interesting) by Mykl on Monday May 21 2018, @02:47AM
That's one interpretation.
The other is that the prices paid for pharmaceuticals overseas (combined government subsidy and retail price) represent the price that the drug really can be viably sold for, and the exorbitant pricing of the US reflects what the companies can get away with when the government makes no effort to protect its own citizens from being gouged.
It should be noted that medicine is not something that can be measured using market capitalism - there are too many influencing factors including patents, startup costs, inelastic demand from patients (who will pay whatever is necessary to stay alive) and all of the regulation that surrounds the market (providing a barrier of entry for other competitors).
(Score: 1, Touché) by Anonymous Coward on Sunday May 20 2018, @02:50AM
You misspelled American Patents First.
(Score: 2, Funny) by JoeMerchant on Sunday May 20 2018, @04:31AM
I find it very unsettling when either Trump makes sense...
🌻🌻 [google.com]
(Score: 1, Interesting) by Anonymous Coward on Sunday May 20 2018, @12:17PM
Let me try another tack at this:
Hawaii floods: In ‘despicable’ act, boater took stranded victims to sea, then demanded money to bring them ashore, authorities say. [washingtonpost.com]
Sick people. Stranded people. People who found themselves in a predicament by no fault of their own.
If a Corporation does stuff like this, its "business". If a person does this, its "despicable".
Now, consider the people who were doing this find a Congressman who will shake his hand and provide him with law and goons to keep anyone else from helping those folk.
Businesses are pretty good at finding Congressmen who will do just that.
And to think we still refer to a Congressman as "The Honorable". God a feel like I am telling a lie if I have to mouth those words.
Make America Groan Again.
(Score: 3, Interesting) by black6host on Sunday May 20 2018, @03:14AM (3 children)
So, someone please educate me. Are not these drugs covered under patents? And if so, and the patents have expired, which would seem to be necessary for generics to take root, why do they need samples? Should it not all be described, at least the important stuff, in the patent?
Sorry if I'm being dense here...
(Score: 1, Informative) by Anonymous Coward on Sunday May 20 2018, @04:12AM (2 children)
https://en.wikipedia.org/wiki/Generic_drug [wikipedia.org]
Basically, you need to prove your generic is the same as the Branded product, and you can only do that using comparisons. You also need to have chain of custody type documentation, so if the branded product manufacturer refuses to sell to you, and puts in their contracts that no one else can sell to you, it is very difficult to prove that your drug is the same as theirs. Just buying some off the street isn't good enough.
(Score: 2) by frojack on Sunday May 20 2018, @06:33AM (1 child)
Change the rules so that the generics need only adhear to the publised patent description, and let the original manufacturer explain why their submitted patent documents were erroneous for 17 to 20 years.
Put the risk on them.
No, you are mistaken. I've always had this sig.
(Score: 3, Insightful) by deimtee on Sunday May 20 2018, @09:13PM
The patented chemical is not the same thing as the FDA approved drug, and leaving something out of the patent description isn't illegal anyway.
So what happens when one of the unmentioned ingredients in the pill is something that mitigates one of the side effects of the patented drug?
Eg. an anticoagulent in something that would otherwise cause clots? The branded medicine works as claimed, people who take the generic have heart attacks and strokes.
Who is responsible? The branded company is certainly going to deny it, and legally they are probably right.
If you cough while drinking cheap red wine it really cleans out your sinuses.
(Score: 5, Informative) by Anonymous Coward on Sunday May 20 2018, @03:27AM (2 children)
There is a drug called colchicine. It was originally derived from the autumn crocus plant, and among other uses helps against acute gout attacks. The plant has been used against gout at least since the first century AD.
As a commonly used drug even in the USA before the creation of the FDA, it was considered by the FDA as "unapproved", meaning since everyone since the goddamn Roman Empire knew it worked, no one had paid to have studies done to prove it worked. So in 2009 the FDA agreed with a company called URL Pharma that they would do the tests and the FDA would grant them a patent for the drug. The previous generic version was sold for $0.09 per tablet; the FDA banned all generic versions and the now monopoly URL Pharma raised the price per tablet to $4.85 and now calls it Colcrys.
If you don't believe this, just consult the Wikipedia entry for colchicine.
For the FDA to try to lay the blame on pharmacy companies for doing what in many circumstances the FDA is directly enabling them to do, is gall on the level that only U.S. politics can achieve.
(Score: 2) by JoeMerchant on Sunday May 20 2018, @04:33AM
Blame it on a previous administration, we're cleaning house this term (said every new administration ever.)
🌻🌻 [google.com]
(Score: 0) by Anonymous Coward on Sunday May 20 2018, @05:39AM
This could be the part of it that seeks to maintain the status quo. The pharma companies better not complain about being put in the spotlight, because if they complain too much, people might figure out that the only reason why prices can raise so high is because of the monopoly status you identified.
So, if the pharma companies respond by lowering their prices, they can keep their monopolies and continue to price gouge, just at a level that's a little less obscene.
The only people who will continue to object to the situation is <sarcasm>just those crazy libertarians who think we should have a system of contracts and ancaps who merely want to reduce government regulation and overreach</sarcasm>.
Everybody else is perfectly happy with having a command economy for pharmaceuticals, <sarcasm>because that's not OMG socialism! if the economy is being commanded by transnational corporations</sarcasm>.