What happens when you cross a proven natural treatment with a crony medical system? A monopoly. Action Alert!
New information has come to light that poses a threat for continued consumer access to intravenous vitamin C (IVC), a potent, safe, and natural treatment for viral and bacterial infections and some cancers. It is a blatant example of our crony medical system. If we don’t stand up and send a strong message to Congress and the FDA, affordable IVC will be a thing of the past.
In 2017, McGuff Pharmaceuticals received FDA approval for an IVC product for the treatment of scurvy, and thus market exclusivity. The FDA notified other manufacturers of IVC that they must stop producing it, giving them a one-year grace period that has now expired. McGuff has subsequently raised the price of IVC.
Some historical context is necessary to understand why and how this happened. The FDA first targeted IVC after the launch of its Unapproved Drug Initiative in 2006. This document laid out policies of enforcement discretion for drugs that were being marketed without FDA approval. IVC had been approved for safety under the original Food, Drug, and Cosmetic Act in 1938. In 1962, Congress passed a law requiring drugs to prove efficacy in addition to safety. Drugs that were approved for safety between 1938 and 1962 could remain on the market for the time being, but a separate process began to assess the efficacy of these products. Drugs that were found to be effective would still require FDA approval (IVC fits into this category); drugs that were found ineffective would be pulled from the market. It is likely that IVC was not seen as a priority in 1962 but came onto the FDA’s radar in 2006.
From the FDA’s Summary Review of McGuff’s product, we know that FDA was in communication with McGuff in 2007 regarding the status of IVC and the need for FDA approval. In the years that followed, McGuff was in regular communication with the FDA regarding the approval of an IVC product.
In 2010, McGuff received a warning letter from the FDA that, among other things, ordered the firm to stop marketing IVC because the FDA determined it was an unapproved drug. At this time, ANH-USA sprang into action to get the FDA to back off IVC.
Note that McGuff received Orphan Drug Approval for its IVC product. The Orphan Drug program provides economic incentives for drug companies to produce drugs that treat rare diseases that affect less than 200,000 people. Orphan drug status entitles a drug company to tax credits of 50% of the clinical drug testing cost, waived FDA fees, and other assistance and support from the FDA. Most importantly, orphan drugs enjoy a longer period of exclusivity: seven instead of five years.
Taking advantage of the Orphan Drug Program is a familiar move. We’ve seen it done with Epidiolex, the CBD drug. Epidiolex won orphan drug designation for the treatment of a rare form of childhood epilepsy. The drug maker now has a government-granted monopoly on the CBD market, knowing full well doctors will prescribe Epidiolex (which will cost $32,500 a year) off-label to patients for many ailments. We will likely see a similar scenario play out with McGuff’s IVC. It has won FDA approval as an orphan drug for scurvy, but since it is now the only IVC product on the market it will be prescribed off-label for a variety of illnesses.
Here’s the main point: taxpayers are subsidizing the creation of drug monopolies that are driving up the cost of healthcare and hindering our access to healthy products.
The FDA-created monopoly on IVC will hurt patients. This is a medicine that is ubiquitous in integrative medicine practices as a key ingredient in Myers’ Cocktails, chelation, and cancer IVs. IVC is not normally covered by insurance, so patients need to pay out of pocket. Intravenous administration of nutrients is crucial, as it allows patients to achieve serum concentrations of nutrients that are not obtainable through oral administration. For example, vitamin C’s antiviral effect has been demonstrated to occur at 10-15 mG/dL, a level that can only be achieved intravenously.
Cancer patients require multiple vials in a single session and can have multiple sessions per week. IVC is also a potent antiviral, so these patients will also have to pay a premium or simply go without it.
Like CBD, the case of IVC is a prime example of the crony medical system—a cheap, safe, and effective natural medicine widely available to consumers is once again turned into an expensive monopoly drug. We must demand that the FDA not enforce market exclusivity for McGuff’s IVC product.
Action Alert! Write to Congress and the FDA, urging the agency to exercise enforcement discretion and allow other IVC products in the market. Please send your message immediately.
108 comments
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We need to stop this madness and put the CITIZENS of this country ahead of profits. We only get one life to live!!!
The FDA has run amok, and must be reigned in for the benefit of informed, adult, American consumers.
Regulations like this always appear to be about profit and feel anti-competitive in nature. This is yet another example of the kind of cronyism which lead to the 2016 electoral upset which got us President Trump, and a welcomed rash of Originalist thinkers on many a federal bench.
I would ask you to rethink this rule for the good of patients who are admittedly out of the norm, for it is that spirit which made an America inevitable in the first place. It is for their love of liberty in the face of everything normal in the world that we enjoy the greatest experiment in government in the world- the nation which has created more wealth and higher standards of living for more people than anyone else in history.
This is true not only of IVC but of many natural, safe and effective treatments and many lies for profit that the FDA cooperates with at the least.
Our system is immoral. It is a business for profit instead of a healing organization for human care and protection.
Medicine in the USA is a monopoly for profit killing all its natural healing competitors.
We must make available all healing practices to all people and have people be free to choose.
This would be financially bad for the monopoly because it will save millions of lives at low costs.
This is not right!
Congress/FDA Please excercise enforcement discretion and allow other IVC products in the marketplace. Thank you.
This action, like so many other “deals” between the government and BIG Pharma is unconscionable! Merck Pharmaceutical’s VIOXX killed my son in 2005 with the FDA KNOWING for quite some time that the drug was deadly. My Son was 38 years old and left behind a widow and a 1 ½ month old son. I am the grieving mother. I will do anything that I can to put a stop to the obscene greed driven duplicity between our government and the industry. I do no have money to contribute but I can write and call.
There are others in my family that are battling cancer and this IVC issue affects them.
I am so sick and tired of our corrupt government keeping actual healthy natural ways of getting healthy from us. This is just another one of many stories I have heard. It MUST stop. NOW.
I’m afraid that I don’t understand. IVC is being banned because McGuff manufactures it? Or because McGuff has been ordered to stop making it?
Market exclusivity for ANY medication is a terrible concept. This does not ‘serve the public’ as you a charged to do.
To the FDA,
Why do you keep making natural products be treated as drugs are supposed to be treated and vetted, and then take the right to produce them away from all but one company who then raises the price out of reach for all but you who make money off it! This is an outrageous thing you do! You are supposed to be a watchdog to protect the consumers, not to protect the companies who market products. Stop what you are doing and do what you’re supposed to do – making available to consumers what will really advance health and well-being, not sickness! Keep IVC a product that is produced by multiple vendors. Competition in the marketplace insures quality and fair prices to us consumers!
Why don’t you allow sharing for this material to reach more people?…your actions would have wider visibility and, certainly, far more influence.
Please allow people to make up their own minds, do their own research and decide what is best for them medically. With the invention of the internet – people can make informed decisions, without the FDA putting their nose into every little thing. Not to mention the fact that Big Pharma owns most politicians…..
THE FDA continues to get too big for their britches, said as nicely as I can muster. Too far reaching, folks.
How will be ever learn to use anything that is not pharmaceutical if it is not available,, especially if it has a current safe track record? The FDA is setting up pharmaceutical companies to be the guiding force in health care.
IVC should be available to anyone who wants an alternative cure. It works.
I have ductal breast cancer and chose a natural treatment. Latvia has been curing cancer for years with virotherapy. The US is supposedly testing it but is taking too long. This therapy kills both the mother and daughter cancer cells without side effects. Big Pharma doesn’t want it on the market. I think we should be able to choose our own options. Doctors should know about them too. I found out about IP6 (Inositol Hexophosphate) and Inositol from my friends who do medical research at Duke University. One of the researchers is a doctor and hates not having these options to give to her patients. Big Pharma needs to butt out of medicine. Patients health should be more important than the nighty dollar.
Please don’t enforce market exclusivity for McGuff’s IVC product and allow other more natural and affordable IVC products.
Leave IVC alone!!!’ Many lives depend on it. There is no good reason for all of us haggling about a substance has been around for many decades and is proven safe given properly. What did you go after chemotherapy drugs and pharmaceuticals that kill people people. This pogrom on vitamin C is it completely Unjust, unneeded, and based on nothing but stupidity and greed!
It is of paramount importance for the FDA to continue allowing use of IVC supplying patients with the necessary nutrients. Battling cancer and other diseases is not just a matter of taking the requisite treatment but also addressing the other nutrient requirements that are, apparently, overlooked by the FDA. Singling out a single manufacturer to be the sole producer, and that then raises the price so that it is prohibitive to the patient is irresponsible, and isn’t directed in the best interest of the patient.
I am writing to urge you to exercise enforcement discretion and allow other IVC products on the market.
Thank you for your attention.
IT IS ABOUT THE PEOPLE. IT IS NOT ABOUT CORPORATIONS MILKING OR BILKING THE PUBLIC
Quit letting people die or live in pain because of your greed. You will all go to hell know that.
Integrity over profit
Compassion over profit
Respect over profit
Stop codifying the BIG PHARMA. People need low cost simple treatments not high cost smoke and mirrors.
Let’s stop catering to the big drug companies
Having been a certified chelation therapist I know how important IVC is too many people. Not just for Chelation but high dose Vitamin C for cancer as well as many other diseases. Frankly, it heals! Plus increases the immune system therefore keeping alive! This is so simple because now it is a necessary part of life and so vitally needed! Wake up!
I am writing to express my disgust and opposition to the systematic monopolization and suppression of effective, affordable and non-toxic treatments for consumer health related issues. It’s one thing to have a bevy of toxic drugs available for everything under the sun – at least we can avoid them – but to keep affordable, non-toxic remedies such as intravenous Vitamin C from consumers is criminal. I am so sick of our health (excuse me SICK maintenance) system. PHARMA along with help from the FDA has become nothing but a drug cartel that bullies and kills people. The third leading cause of death is properly prescribed medications and medical errors in hospitals. Great.
PLEASE allow other IVC products to enter the consumer market. We desperately need them.
It becomes more and more evident that American install an administration that is favorable to promoting research into cures for diseases that incorporate both pharmaceutical and natural approaches. It becomes more and more essential that Americans stand up for their rights to select both approaches as the situation warrants.
To Congress and FDA,
To allow exclusivity to Mc Guff’s IVC products on the market that benefit people in so many ways, otherwise that would be a monopoly. We will sue to maintain our freedoms!
Intravenous vitamin C should not be a monopoly for one drug company, McGuff Pharmaceuticals.
Prices for single source drugs always skyrocket and prevent broad access to them due to cost.
Other drug makers should be not only allowed, but encouraged to also produce intravenous vitamin C.
To whom it may concern,
I am disappointed yet again by our public officials at the FDA in their potential decision to create an exclusive right to distribute a therapy that was previously available from multiple sources. This amounts to an unfair business practice and goes against our capitalist, free market system. Having multiple sources ensures a steady supply and keeps prices in check. We’ve experienced similar poor decision making around other therapies creating an unnecessary monopoly. Such practices do not reflect well as to the integrity of your management of the nation’s pharmaceutical industry. Allow others to produce this product without exclusivity limiting the availability to those who need it in the marketplace. One day you, or a loved one may need one of these therapies and it will be unavailable – how will you justify your decision to allow this to happen then? Where is your moral compass?
The very history of intravenous vitamin C (IVC) being an approved treatment under the FDA since 1938 tells us what the current status should be: approved and with no exclusivity for a 2006 applicant.
The McGuff company’s status of “Orphan Drug Approval” is unjustified. Clearly many other companies were supplying the product since 1938 and any of those qualify to share the right to manufacture and distribute IVC.. Another reason to avoid an Orphan Drug Approval is that the price of the IVC should be kept at as low as possible since insurance puts the payment costs completely on the patient.. Unlimited companies who qualify should be allowed to produce and distribute IVC to have competitive pricing. The MCGuff company has not innovated nor have they improved upon the treatment. There is no reason to limit the production and distribution of IVC for anything other than basic standards of reliability, accurate labeling and safety. Absolutely no Orphan Drug Approval should be granted for IVC, to McGuff or any other company..
Please stop destroying our freedom to choose natural supplements for healing and restoring health. I used high dose IV Vitamin C to heal from Breast Cancer. Until FDA decision-makers and leaders of congress experience for themselves or their families the horrors of cancer and other diseases that these natural substances cure they will not understand the need for them. It is all about the money and kick-backs you receive for your vote to destroy what is not a money-maker because it is from nature. When you have no cure left for your spouse or your child perhaps maybe you will understand the mistake you are making in taking away our rights to choose what God created in his Farmacy, rather than what has been created in man’s flawed poisonous Pharmacy that is working slowly to destroy mankind.
The FDA was created to protect people. Don’t let government agencies abet the predation of Americans by corporations
Please do not allow a monopoly on IVC products.
It seems the FDA is more interested in protecting
Their friends in the pharmaceutical business than
Promoting health and wellness.
This is outrageous! We the consumers and the patients need to have access to Intravenous vitamin C. I have had IVC and benefitted from it as a cancer patient. Please exercise enforcement discretion and allow other IVC products in the market.
We don’t needs medicinal monopolies controlled by big pharma!
Linus was right
I strongly disapprove of turning products that arise from the natural medicine market into expensive commodities controlled by a single company. This avaricious and destructive behavior must be stopped. I suggest law suits against companies that attempt to monopolize these markets, and criminal charges against those who actively seek to deprive others of important life cures.
To whom it may concern:
Please allow IVC products in the market without turning them into a monopoly drug!
Please do not let the FDA enforce market exclusivity for McGuff’s IVC product!
Thanking you in advance.
Kathryn Thompson, private citizen
This is hideous. Hospitals in Mexico have been giving IV VITAMIN C to cancer patients for at least the past 50 years as have many other countries.
This is awful, sad, disheartening, and downright depressing. WHY WOULD THE FDA CREATE MONOPOLIES? To help the citizens of the US, it should be helping create competition. Healthcare costs in the US only seem to be going up. It is unsustainable and people are dying because of it…
We need to outlaw the FDA !
Please allow other IVC products in the marketplace
Until we carefully chose the members of the FDA and EPA as well as insure that President Trump is aware of the problem and the need for radical change, we are stymied. WRITE YOUR CONGRESSMAN!
I call ‘big pharma’ GREEDY, HEARTLESS, PREMEDITATED MURDERERS for good reason This is just one more!
the FDA’s bed is getting larger…pretty soon it will crack and fall apart. and I will be there with million others to fire up the kindling wood.
Like CBD, the case of IVC is a prime example of the crony medical system—a cheap, safe, and effective natural medicine widely available to consumers is once again turned into an expensive monopoly drug. We must demand that the FDA not enforce market exclusivity for McGuff’s IVC product.
Please exercise enforcement discretion. Allow other IVC products in the market. Thank you.
My wife is a Cancer survivor and has benefitted from Intravenous Vitamin C. We pay out of pocket and it is not cheap. Orphan drug approval will make it unaffordable to many other Cancer patients.
Please allow all pharmaceutical companies to prepare this vital nutrient in IVC form. Most people do not have the disposable income to spend on higher priced IV vitamins that are essential for many conditions and diseases. Furthermore, there should be healthy competition in pharmaceutical prices.
There should be no favored pharmaceutical companies, they should all be treated equally.
Big Pharma is like the Medicine Mafia, also the FDA, who are they to make that determination that will alleviate the effects of Cancer, or eradicate it!!! As concerned citizen, we must stand up, as a nation and a law should be created to have the right to choose Natural Medicine, etc. For ones health.!!@
Campaign Financing is Corruption at it’s highest, Especially from the Pharma Cartel. This is why CBD, bio-identical medicines and lifesaving supplements like Vitamin C IVC are kept off the market. It’s a disgrace to the medical industry as the Pharma Cartel funds the Universities as well. So we have doctors that know very little about these life saving methods. One has to fight to get hospitals to use such beneficial treatments. What happened to the hippocratic oath? It’s been lost. “I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to any one if asked, nor suggest any such counsel. Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and CORRUPTION.” We’ve strayed so far.
FDA – Do Your job!
Please do not grant monopoly status to manufactures of intravenous Vitamin C (IVC) solutions, nor move to ban the use of IVC as treatments as a routine medical use to combat infections and cancer.
Taxpayers are subsidizing the creation of drug monopolies that are driving up the cost of healthcare and hindering our access to healthy products.
Allow CBD are the market. I have a right to the therapies I want to use.
I know you risk losing FAT REELECTION CASH from the pharmaceutical industry, but you don’t work for them–you work for us–citizens of the United States. In fact, you’re supposed to be protecting US from THEM.
Like CBD, the case of IVC is a prime example of the crony medical system—a cheap, safe, and effective natural medicine widely available to consumers is once again turned into an expensive monopoly drug. We must demand that the FDA not enforce market exclusivity for McGuff’s IVC product.
Please keep natural products on the market without over regulation.
WHAT are you thinking – depriving patients of ways to recover and get well?
Continue to allow Vitamin C IV therapy at an affordable cost and do NOT preclude other providers
Such a straight forward low cost way to get well with IVC infusions for cancer and other patients. We must recognize the efficacy and the ability to keep costs down .
This is so outrageous!!! I am fed up with the FDA not working on behalf of the people. This has to change. FDA must allow other IVC products in the market.
Please do not take away our right to choose alternative medical treatments.
So fed up with a corrupt government and corrupt medical system taking health from safe vitamins and foods and calling them drugs to benefit corporate coffers and stiff the public and taxpayers!!!
The karma of greed and harming others for grotesque profit is a heavy load.
I pary for those participating in the corruption be they corporate CEO’s, Board members, Government agencies such as the FDA, EPA, FCC, NIH, CDC or politicians.
As a citizen I am nauseated and angry for the sell-out that harms U.S. Citizens!
Government tyranny, collusion, and abuse of power. If the FDA were the President, it would be impeached. If there are any libertarians out there, call Sen Rand Paul or anyone else in the elected government sensitive to preserving our freedom over that of large pharmaceutical corporations.
One more case of the taxpayer covering the cost for the opportunity to be ripped off by a greedy company!!! People will die from your callous behavior!!!!
Allow IVC drugs 2 stay on the market
Once again the FDA is creating a monopoly enabling a single producer to control the marketplace. Sadly, it is a natural product like vitamin C.
Exercise discretion and allow other IVC products in the market.
Why not take buffered C. Ready mixed from the store/supplier or buy Mg, Ca, etc. citrate and mix 1 to 100Vit.C. Ii take up to 10-15gms a day to prevent recurring skin cancer, after surgery.. a runaway case. No gut problems. Slightly loose bowel approaching 20gms.
As an integrative veterinarian I use IVC frequently. This therapy has helped me to improve the health of many of my patients and often has saved their lives. Cost often is a limiting factor for treatment. The cost of Vitamins C for i.v. use from McGuff has risen considerably already. Competition from other compounders could help to keep the expense down.
I will not beg the ruling powers in this world for mercy It will be ordered in a court of law There is a time for everything under the sun. God’s law will over rule what they have done. Its coming.
We must stop the high prices of vital drugs, including drugs for cancer..
Urging you to exercise enforcement discretion and allow other IVC products into the market.
IVC products hsve really helped me in the past. Please allow IVC vitamin C and others!
I get the impression that liposomal Vitamin C capsules can be as effective as IV administration. We often use them.
The safety and efficacy of Vitamin C is beyond approach. There are exactly zero good reasons to restrict it in any way.
McGuff Pharmaceuticals is using the Orphan Drug Program to take advantage of Americans,
particularly those battling cancer, to generate profits from a safe, natural therapy which has
been in use since before 1938: intravenous Vitamin C. With costs equaling the average income
in many regions of the U.S.A., this is unacceptable.
Members of Congress take an Oath to uphold the Constitution of the Untied States of America, as part of a government that is supposed to be “Of the People, By the People, FOR THE PEOPLE…”
– NOT corporations.
Allowing corporations to create monopolies of safe, natural therapies under the Orphan Drug Program is, in our view, an abuse of power by the FDA. It is clearly the duty of Congress to
halt the abuse of laws and/or regulations by corporations in their pursuit of profits – especially
where this creates needless hardship for many Americans who can then no longer afford certain
safe natural therapies, especially those with a long history of use.
Thank you for HALTING the abuse of the American people (real people, aka ‘natural persons’) by corporations in their irresponsible pursuit of profits, especially in the areas of health, drug access,
and medical care.
I agree that the FDA seems to be making decisions based on financial incentives for business rather than for the benefit of the American public. Some of the compounding law as seem authoritative and because on pharmacy made a mistake, the entire population of the US no longer have affordable access to therapies that work. The one compounding pharmacy should have been out of business for what they did. However. it is nearly impossible to have a doctors office make a Myers cocktail for me based on what I need because there are more than 3 ingredients. I interpret this as an assault on my personal by the FDA.
STOP the exploitation of Americans by pharmaceutical corporations.
McGuff Pharmaceuticals is using the Orphan Drug Program to exploit people, particularly folks
fighting cancer, to generate profits from a safe, natural therapy which cost them ZERO in reasearch and development: intravenous Vitamin C. This safe, natural vitamin therapy has been in use since before 1938. The monopoly McGruff enjoys under thee ODP allows them to charge unjustifiable prices, with annual costs adding up to amounts approaching the average yearly income
in many regions of the U.S.A. This is NOT acceptable.
Please exercise your enforcement discretion and allow other IVC products in the market..
Ethics, ethics, ethics. Greed, greed, greed. How about decision-making without $ attached? I dare you.
It is time for our news networks to inform the public what Congress and the FDA have done to limit access to health alternatives.
Perhaps if they had cancer, they would be looking for a comphrehensive approach to wellness.
Please exercise enforcement discretion and allow other IVC products in the market.
Stop marketing IVC now!
Stop messing with our medical coverage. Trump care is a farce.
It’s a shame
Are you in the job of protecting drug monopolies or consumers? There is no risk for taking Vitamin C, and you are raising the price in favor of a drug monopoly. Please allow consumers the same options for IV vitamin C that they have always had. Our health care is already expensive. Why make it out of reach?
The world is starting to look more closely into the System that deprives us of our health choices–for profit; whose side will you be found to be on?
IV vitamin C is a safe and non toxic treatment for many medical conditions and should not be removed from the medical armamentarium. It is my feeling that IV Vitamin C be allowed to be produced by several pharmacies!!
Dear Congress.
This is the Land of the Free. Please do not take away our right to choose what is best for OUR bodies. Please do not let Big Pharma, the FDA and the CDC control what happens to our health. Please educate yourself on the many benefits of functional medicine.
Thank you for paying attention to this very serious matter.
Please please leave Vitamin C IV alone. It has also helped me tremendously.
If this goes the way you want it to go Many people who depend on this will suffer on your hands. Do you want that?
I wouldn’t want that.
I am horrified that any medical care would be exploited for profit in such egregious ways as what is happening with IV vitamin C and other alternative treatments. No drug company should be allowed exclusive rights to such treatments and then raise the price astronomically. This is a crime, and the FDA is colluding with it. PLEASE PUT A STOP TO THIS INJUSTICE!
I urging the FDA to exercise enforcement discretion and allow other IVC products in the market.
The idea of patenting an essential micronutrient just because it treats its own syndrome of definciency is patently ridiculous.
Please support vitamin c drips
It is tiring to have to always force the FDA to do its job of protecting the public instead of doing as they are told by the pharma and medical industry. We have the right to use whatever we choose to treat illness.
This arbitrary ruling will result in needless illness & possibly DEATH for those who can not afford the exorbitant & unreasonable price. What if you or a loved one needed this medicine?
Cancer patients deserve dignity and choice when considering treatment.
Vitamin C IV saves lives. I have used it numerous times for infection and prior to surgery. It is safe and highly effective. Allow this wonderful life saving product to remain accessible to patients.
Shame on you!
Now that McGuff Pharmaceuticals has raised the price for Intravenous Vitamin C, please do not let them have exclusivity for a natural remedy.
Thanks for your consideration.
Please save IVC therapy
Please leave the iv vitamin c as an option for people who need it. It has not caused any adverse affects to people.
To all Congress and the FDA,
Please do not enforce market exclusivity for McGuff’s IVC product. We need other IVC products on the market to ensure all people will be able to access them in an affordable way. Do not make it a monopoly. Thank you.
IVC (intravenous Vitamin C) has been offered inexpensively to many
sufferers of bacterial and viral infections, cancer, and other ailments that do not respond to oral administration. This has been a lifesaver for countless patients.
Now comes a pharmaceutical company product, that is backed by the claim of exclusivity. Why? Because the FDA enables pharmaceutical companies to establish monopoly control of crucial substances such as IVC, at which point their prices skyrocket, becoming unaffordable to most patients. This is medical negligence in my opinion. The Hippocratic oath requires that you first Do No Harm. The FDA aids the pharmaceutical companies in Doing Harm by denying patients access to natural substances at affordable prices.
It’s all about the money when it should be all about protecting patient access to lifesaving products. It’s high time the FDA started putting patient needs first and that needs to begin NOW.
Enforcing market exclusivity for IV Vitamin C(s…ascorbic acid, ascorbates) by one manufacturer will drive up prices for a natural substance that has a long track record of safety., and ever increasing peer reviewed publications proving its efficacy and utility in multiple diseases, including scurvy,cancer, viral infections,etc,etc, etc.
Please exercise enforcement discretion regarding this, to allow and foster a competitive market, allowing greater access , with more production and lower costs,to physicians and their patients!
Sincerely,
F Alex Leon, MD
IVC products are an important source of adjunct therapy. Please don’t restrict the access to this modest measure at helping so many at reasonable & manageable costs. Don’t make it an exclusive, one provider product.
Linus was right