FDA Just Approved the World’s Most Expensive Drug

July 10, 2019

…that will cost $2.1 million.

The Food and Drug Administration (FDA) recently approved a gene therapy drug for a form of spinal muscular atrophy (SMA). Novartis is pricing the drug, Zolgensma, at $2.125 million, or $425,000 per year for five years.

The drug is meant to treat children under 2 years of age with SMA, an inherited disease that, in its most severe form, can cause infants to die or require permanent breathing support.

Novartis faces competition from Biogen for an SMA gene therapy drug. Biogen’s product, Spinraza, was approved in 2016 and also comes with an eye-catching price tag. Spinraza requires regular spinal infusions that cost $750,000 in the first year, then $375,000 per year thereafter.

Novartis noted that it is working with insurers to implement pay-over-time and other schemes to help patients get the drug.

This is par for the course for Big Pharma and our crony medical system. Many blockbuster drugs will soon be off-patent and open to generic competition. Drug companies have also had difficulty developing new drugs. To make sure profits don’t suffer, Big Pharma is focusing on developing expensive drugs for rare diseases that can get expedited approval through the FDA’s orphan drug program. Orphan drug designation gets drug companies prolonged market exclusivity, waived FDA fees, and tax credits on their research and development costs. Big Pharma can then charge exorbitant prices for the drug, justifying the high price because targeted disease affects so few people.

Recall, too, that the FDA has allowed drug companies to steal natural substances and turn those into expensive drugs. CBD oil has been available in supplement form for years, but the FDA just approved a CBD drug for a rare form of childhood epilepsy that will cost $32,500 a year. L-glutamine can be purchased for $10 dollars a bottle, but the FDA approved an L-glutamine drug that will cost $40,000 a year. In both cases, the drug company can petition the FDA to remove the supplement version from the market, eliminating competition that could provide consumers access to an affordable option for these natural substances.

It’s no secret that healthcare is a disaster in this country, with skyrocketing medical costs. We can’t hope to address these spiraling costs if we keep taking cheap, safe, and effective natural medicines and turning them into expensive drugs.

84 responses to “FDA Just Approved the World’s Most Expensive Drug”

  1. Robert McKinnie says:

    Banning natural cures in favor or exhorbitantly priced artificial clones benefits no one. Doing so is simply catering to corporate welfare. We need to be concentrating government and private resources to better health through natural health.

  2. Mel White says:

    Putting profit before human life, what SCUM.

  3. Betty says:

    Other than the $$$ they will make, are you sure that this is not a means to eliminate poor people? Gentrification of the earth? Hmmm. probably no drug to keep humans from dying from global warming though.

  4. Chester Vidacovich says:

    Big Pharma’s greed knows no bounds. We need a man like Teddy Roosevelt (the trustbuster) to put these rapacious idiots in their place.

  5. Mary Helen Venos says:

    What is the point of having a drug that NONE but the ultra rich can afford? It is disgusting. The drug companies have completely lost their sense of doing good for humanity… if they ever had it. I hope the decision makers rot in hell.

  6. Yvonne Segal says:

    The entire medical system in this country needs to be revamped. Citizen’s health should not be for sale, traded on the stock market and included in the GDP (gross domestic product.)

  7. Carol L. Book says:

    Drug companies are being given power they shouldn’t have. If it doesn’t stop, people are going to die.

  8. Robert Wolpa says:

    Outrageous but not surprising. The time is coming when ALL pharmaceutical companies be nationalized.

  9. Cheryl Fontaine says:

    As long as we have republican congressmen taking big payoffs from pharma drug prices will continue to skyrocket..

  10. mahowPlease proectProte says:

    Please protect consumer access to checp. life saving , safe and effectve natural medicines.

  11. Rita Butler says:

    Instead of investing in these drugs with exorbitant prices the FDA should be supporting alternative and holistic treatments that could help so many people without huge costs or side terrible side effects. They should also be working with other agencies to clean up our water, air and improve our soil. They should ban chemical, energy and the MIC companies from further polluting our environment. This would do way more to improve the health of people in this country than a few super expensive drugs.

  12. Jamie Tsitouras says:

    There is no reason to keep affordable medicines and supplements from the market just for the sake of greed. This is unconscionable.

  13. Andrew Jacobson says:

    Why would sane people allow or accept this abomination of human decency to occur? Answer: We live in a world that is insane and our leaders lack the courage and commitment to humanity to intervene on our behalf.

  14. jim says:

    How about doing something positive for the public good instead of greedy corporations, like for the reason you were originally founded?

  15. Mark Krause says:

    Nothing surprises me about Big Pharma and The FDA . Because of fraudulent medical devices I have worked with , I formed a group – FDA : Can We Trust Them ? I am a Laboratory Technician , Hospital . About CBD Oil , my mom has Parkinson’s , and I may be getting it , , , people should just be able to self medicate with home grown marijuana plants and the Government should just keep its face out .

  16. Donna Phillips says:

    It is past time to do what is morally right and responsible. It is NOT responsible to price drugs for thousands of dollars yearly. It is GREEDY and WRONG in every sense of the word!

    Does anyone in the drug industry consider the possibility of their loved ones needing a remedy that costs that much? It seems that they don’t.

    Why does a country that had the capability to put a man on the moon – which made them the envy of the world – not wish to continue to warrant that envy by caring for their citizens through development and pricing of medicines at a reasonable cost – that even the poorest of citizens could afford – without choosing between putting food on the table and their health?

    Franklin Delano Roosevelt is turning over in his grave…

  17. Alan Wayland says:

    Argh. Take their protections from the politicians they have in their pockets.

  18. joe Spies says:

    This is absolutely outrageous – how can our government/politicians stand by and do NOTHING??????

  19. raquel says:

    why don’t you allow a link. I would like to send this to my network and cannot do so as I cannot copy your link to the article.

  20. lyn buerger says:

    Unfortunately, we have learned that MONEY is the power in our country and in most of the world. I am coming to the realization that it is time for our planet to rid itself of it’s parasites and start to heal it’s self and maybe do a better job on the next go.

  21. I didn’t know that L-glutamine is a supplement for childhood epilepsy, or for epilepsy period. Some told me that is was good for treating gut health problems, digestive system issues. Does this supplement help with that too, or is it just for treating epilepsy??

  22. Mort says:

    My daughter-in-law is a PHD and works for Novartis in Canada researching mainly cancer drugs. She tells me that Big Pharma” can spend hundreds of thousands on developing just one medication, ensuring that the results are safe and effective. Much research results in failure or abandonment of a certain attempt; so they turn to something else, but the money has been spent but is not recoverable and the costs are passed on to all projects.
    I’m not defending Big Pharma’s seemingly exhorbitant pricing, but unless they recover all expenses, they will not be able to continue their research. As for executive salaries, just ask any NFL or NBA team — you get what you pay for!

  23. Ted nelson says:

    Keep up the great reporting very much appreciated

  24. Jay says:

    Drugs only treat symptoms. Dr. Linus Pauling said all disease starts with malnutrition. Nutrition is much less costly and no side effects.

  25. Sheila A. Rosart says:

    It is disgusting that the FDA aids and abets the thievery and cruelty of big pharma!

  26. R Austin says:

    OUTRAGEOUS to charge struggling families with a sick such an expense!!
    Please think if it were you and you had an average median income?
    What would you do?

  27. Earl E Stevens says:

    The price is NOT justifiable.Earl.

  28. What in the world is wrong with drug companies and governing agencies like the FDA. The drug companies charge outrageous amounts for new medicines that have the power to save lives and idiots like the FDA approve of it. When is this practice going to change? Remove all the big shots at the FDA and put in restrictions on what is considered proper on pricing. Too many drugs cost much more than they need to. It is time to remove and replace people or whole agencies that operate with the people not being considered as important enough to make cures affordable.

  29. JB Marks says:

    The government and pharma companies need to be stopped ripping off the people across the board. Both are lining their coffers at the expense of those people that need help medically. It is a disgrace the greed that is involved and the corruption

  30. Daniel Safron says:

    How the FDA and Big Pharma operate is truly cruel, heartless, inhuman and not characteristic of a free country, as consumers need to be able to buy affordable supplements.

  31. Daniel Safron says:

    They’re not into healing people, but into creating lifelong customers.

  32. MK Perris says:

    Isn’t that just typical – take away the plants that can help us and replace with drugs that few can afford!!!
    Get back to basics folks – grow your own food, exercise and feed your mind with positive thoughts and ideas. Create communities – get neighbours to take care of neighbours.
    Form associations – we need to keep fighting for our natural health that works much better than any drug!

  33. Lynn says:

    That’s horrible. We need to be able to use the least expensive remedies possible. Otherwise people won’t be able to afford simple things such as cbd oil.

  34. Donna Greenberg says:

    The FDA needs to clean house ! Evidence of all the big Pharma employees they have there ! It should be against the law ! Shameful the cost of the medication. No one can afford it and not insurance company will cover it. , so what’s the point !

  35. Michael Kavanaugh Jr says:

    There are times where making a profit is not the moral thing to do – and taking advantage of someone’s health problems is one of those times.

    All medical care except certain vanity medical procedures should be provided as a not for profit service.
    And those vanity procedures should probably be just banned outright as harmful.

    We need to go back to when most insurance plans were a nonprofit service model and many hospitals we’re as well.
    Greed is NOT good – it is a single

  36. Debby Klein says:

    Those protections would force drug companies to not be allowed to remove natural holistic items.

  37. Jan stalnaker says:

    this is disgusting and totally unacceptable…big Pharma needs to be held in check…profits over
    people’s health is grotesque…

  38. Donna Leveron says:

    More of the out-of-control greed by big pharma.

  39. Rebecca Jamin says:

    This is absolutely criminal! This is nothing more than organized crime, legalized and endorsed by these alphabet agencies. They are preying on the parents of gravely ill children and it’s sickening. Take away what Mother Nature has provided us for the almighty dollar. These pharmaceutical companies and the FDA care 0 about the very people they are supposed to protect and help.

  40. jorge jtamargo says:

    Let me get this right the government give a financial break to these companies to create a special drug, and after these financial breaks they are allowed to raise the price of drug to whatever they wish, even Thu these financial breaks was given by in actuality the tax payer who now has to pay a his or hers complete life earnings to get,unless very wealth to get these drugs . This must be one of those special deal that was done by the king of deal makers Mr. Trump , and if by previous administration must be a Corporate controlled Republican sponsored bill .

  41. A Knight says:

    This is shameful. It’s all about money, not about helping human beings. . If there is a drug that can help people, it should be made affordable enough for people to be able to get it.

  42. How many times have we heard the nations leaders tell the population that they were going to give us medical protection at a reasonable rate. All the leaders have to do is step in an curb this idiotic plan of any drug company to enrich their pockets. It used to be that when a cure was discovered for a problem it was met with reasonable care and the public could enjoy the findings. Now we pay the piper and thos2e that need it the least profit by it. Lets show a “standard” price of medical help to all as was promised.

  43. Evelyn Dreher says:

    The FDA should be shut down. It’s clear that they are bought and paid for by big pharma. Who’s is regulating the regulators???

  44. The FDA should be shut down. It’s clear that they are bought and paid for by big pharma. Who’s is regulating the regulators?

  45. Yaping Tao says:

    All diseases are manmade, God has given each of us a perfect self functioning body, any human intervention will only confuse the body normal function.

  46. vivian idriss says:

    At some point, even legislators and Big Pharma heads will be in a position where they need some of these drugs that are so expensive, or they will no longer have access to a natural substance because the FDA, in hopes of more profit, has outlawed it. Legislators, please do your job. Work for the people who elected you, or quit your position. Quit working for special interests. This is in humane and criminal.

  47. vivian idriss says:

    Legislators need to stop working for the special interests and Big Pharma, and start working for the people who elected them. One day, you will need one of these drugs that are priced out of reach, and you will not have the privilege of the natural alternative, since it was outlawed in favor of more drug company profits. Shane.

  48. Carol Stevens says:

    unbelievable……..just how much money is enough for pharmaceutical leeches?

  49. Deanne Luzaich says:

    This is an outrageous price for any kind of medicine ! Nobody can afford that and the FDA is ridiculous to approve it .

  50. Patrice Burke says:

    A drug that is meant to cure children’s spinal muscular atrophy (SMA) should be within the financial grasp of all parents, not just the very rich. Why then is the price going to cost as much as two or three middle income Homes. This is deplorable. Our worst nightmares have come to life.

  51. Rhonda Reed says:

    Drug companies should not be able to take a natural substance, market it as their own, raise the price and eliminate competition for the sake of a CONCEPT… MONEY (or filthy lucre). This is wrong.

  52. This is patently absurd, esp. with the increasing evidence that mesenchymal stem cell therapy can address the symptoms of spinal muscular atrophy more cost-effectively.

  53. Jan Shima says:

    Drug Companies taking natural substances and turning them into drugs is a crime. This cannot be allowed and we need to speak up. There should be laws preventing them from doing it. Who in Congress will write a law to prevent this???

  54. Debbie moore says:

    It is WAY PAST TIME for the pharmaceutical companies to be capped! The ceos etc do not need to be paid these hellish salary’s and it is insane that they are grossing the profit they are every 3 or 4 months. If this continues I think there should be a law letting American citizens the right to mail order their scripts from Canada. I am lucky enough to be able to drive to Canada for what I might need. So if they continue to have trump in their pocket and to screw the American citizens in this way it is time for us to zScrew Them

  55. Marcey E Siegel says:

    How can the FDA have the chutzpa to take safe and natural supplements away from those who use them effectively?!!! I know, I know…follow the $$$. UGH.

  56. Bev Greenlee says:

    And you wonder why health care is for the shareholders and pharmaceuticals. God help us all. These Science of Stupid people at the FDA should all be fired! And fired by Trump because there is no reason why natural health should be on the bottom rung of treatment. Keep everybody sick, take all our money and what do you have? A sick welfare state, run by a bunch of arrogant, ignorant, elitist wonk. The FDA and CDC work for the people remember? You know those useless eaters that pay taxes on worthless dollars so that you can live high on the HOG. Do the right thing FDA and start working for us.

  57. Cindy Rose says:

    I find this appalling as a consumer & healthcare professional. This is one of the reasons are healthcare system is falling.

  58. Sharon says:

    It should be against the law for big pharma to profit from natural products we are already using that work. It’s like, they can “shut us down” but we can’t shit them down over a natural plant that God gave us ? The pharmaceutical companies have been way too powerful long enough. The FDA, FTC & Big Pharma have gone too far. It’s time our congressman acted !

  59. khali says:

    They have not regards for human life, all they think is of money, incredibel!!!

  60. Warren says:

    Does this sound like monopoly? The USA broke up the telephone companies years ago to prevent total control. Now Big Pharma is trying to monopolize the sale of L-glutamine to make sure they make their money and no one else can. I believe L-glutamine was around and made by the creator in which they got the ideal.
    “the FDA approved an L-glutamine drug that will cost $40,000 a year.”

  61. Robert Hoekstra says:

    The ability of the drug industry to petition the FDA to remove a supplemental version from the market and eliminate any competition in the process doesn’t provide consumers access to an affordable option for natural substances. The ability of the drug industry to squash the competition compliments of the government regulators who are beholden to the drug industry that their supposed to be regulating smacks of something Orwellian.

  62. B Sampsel says:

    This is what happens when Government can regulate something. Payoffs, favoritism to one company over another, etc. This has been going on since Teddy Roosevelt started his wars against corporations to select his favorites (lookup what he did to catsup companies back then).

  63. Ken says:

    We need to get financial support for the FDA back to where it used to be: the US Government.

    Currently, the FDA is financially supported by the very group the FDA “controls” (of course, “We the People know” what that means – FDA is actually controlled by the group it “controls”)!!

  64. Deane Johnston says:

    Absolutely appalling what BIG PHARMA is doing to our health care industry!!!!!!! And killing thousands, to boot, with ALL their MANY prescribed medications. Seniors seem to be the targeted market.

  65. Walter Comer says:

    Big Pharma and trump are disasters. I have a rare disease called Erdheim-Chester disease. I can’t get the cure due to pricing. Who cares? I’ll be dead, soon!
    Sincerely,
    Walter Comer

  66. Walter Comer says:

    Big Pharma and trump are disasters. I have a rare disease called Erdheim-Chester disease. But, I can’t get the cure because of pricing. Who cares? I’ll be dead soon.
    This country elected a billionaire from realty? We have four more years of this garbage after this term, unless trump invokes some kind of law that requires him to stay in office.

  67. Terry L Leland says:

    Time to gut the FDA. They stand with big Farmacon and Not the people.

  68. Charlene Sugihara says:

    This is a shameful form of robbery! The FDA should be investigated for its cronyism with Big Pharma.

  69. Richard Wissler says:

    The FDA is now a for profit concern with agreements deals and kickbacks with probably every major branch of medical management. GEE, What a surprise ! We are cattle to be milked. If you are just learning this you have been asleep, OR you are in on the take..This is just a ploy to play on the emotions of wealthy people with sick kids and they’ll probably make millions with it. All our shock and outrage will not do diddley to change it. they win we lose ….. Gosh !

  70. Leni Michaels says:

    How, in good conscious can these companies charge these insane prices. And at the expense of defenseless children.

  71. Dr S Barnes says:

    So much for free market economics and the American legal system!

  72. Stay healthy says:

    This is why our insurance rates are so high. Pharmaceutical drugs are driving medical costs. This is criminal that they are charging do much for this drug. This is to keep the stock price high not to help anybody. Generics were accused for price fixing so the competition is more of an illusion than reality

  73. Karen L Kirchdoerfer says:

    It’s no secret that the FDA is a wholly-owned subsidiary of Big Pharma. They are a disgrace!

  74. Ruth A. Yacko says:

    It is bad enough that the prices of all Big Pharma drugs are over-priced to say the least. Furthermore it is criminal to develop drugs for such diseases that will grant them skyrocketing prices using such devices as “Orphan drug designation.” And then to make sure the only help for patients is through their medications; they make absolutely or try to that the natural application is made illegal. They have been doing this since the beginning when medicine became what we have now. An example would be aspirin using the salicin acid (sp?) from the Willow Bark. Didn’t their influence began around the 1900s when with the support the corporate bigwigs of the time teamed up with them to destroy or try to alternative medicines such as herbal an homeopathy. Currently their influence is through a powerful network of lobbies. We must continue to fight wherever we can for alternative medicine and supplements.

  75. Bonnie Abbott says:

    This is insane….stop the pharmaceutical acquiring control of natural substances.

  76. Linda Becker says:

    Stop using pharmaceuticals. Find a good herbalist; Chinese Medicine Doctor; Homeopathic Doctor; Functional Medicine Doctor and find your way back to health. Taking a pill does not create health, it just suppresses body’s cries for help.

  77. Sue says:

    Inhumane greed.

  78. Michele Ortolano says:

    Sickening

  79. Karen says:

    How is it that pharmaceutical companies are allowed to have supplementals removed from the common market – especially things like CBD oils that can be purchased in organic form from producers who have researched and worked with unhealthy individuals with tremendous success for much, much less cost? This is disgraceful!

  80. Donna Estes says:

    Allopathic medicine is a joke in this country! Doctors prescribe too many drugs, drugs that are really needed are very costly and the pharmaceutical companies are their own regulators and do whatever they damn well please. It is a travesty. Also the fact that they want to dictate what happens to a persons body is just wrong!!! I will never be told I have to get a certain treatment, drug or vaccine!! The FDA and other watchdog agencies that are supposed to be looking out for the people have slapped us in the face by bedding down with lobbyists and money or favor contributions. Makes me unproud to be an American. Corruption at its finest! These exorbitant prices only bankrupt people with sick children or family members. I know research and development are costly, but there’s too much corruption for me to feel sorry for any filthy rich corporation who runs roughshod over its customer/patient base.

  81. Ron Shields says:

    Natural products have fewer side effects if not at all and far less expensive.

  82. Shirley Walker says:

    It’s time we all stand up to big pharma & fight to keep our natural supplements available on store shelves. Big pharma does not have any of our best interests in their sights. Only money & how much can they make from it. The insurance companies need to tell them to make it affordable or take a hike!

  83. Sarah dixon says:

    As usual I just can not understand how FDA and big pharma live with themselves knowing these are life changing meds and no one can afford them.
    Shame on you, all of you…..
    What if it were your kid?

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