An almost certain-to-pass bill with a new and noxious provision may be voted upon this weekend, and we need your help to stop it!
The Senate compounding bill we have been telling you about has now been scrapped because of the outcry from consumers like you. They started over from scratch and made many improvements. But they also added a new and really bad provision.
This section of the bill would ban the delivery of compounded nutriets delivered by IV (directly into your veins by a doctor) unless they are either on a pre-approved (USP Monograph) list or are components of FDA-approved drugs!
Think of that: a doctor may not be able to give you a vitamin or mineral you need unless it is not already in some completely unrelated drug! A doctor could use vitamin C because that has been included in some FDA-approved drugs as an additional ingredient. But he or she could not order some other vitamin or mineral which does not happen to be an ingredient of an FDA approved drug. How can this possibly make sense?
This provision resurrects section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C). Section 503A has been deemed invalid by federal courts: it’s currently the law only in the fifth circuit, which is comprised of three states—Texas, Louisiana, and Mississippi. This new bill would supersede the court decisions and make it the law throughout the country.
Besides making compounding nutrient IVs illegal unless they are pre-approved or contain elements already in FDA-approved drugs, section 503A also says that each state has to enter into a Memorandum of Understanding with the FDA. This Memorandum of Understanding would likely be used to severely limit interstate sales of compounded medications.
In other words, you might not be able to get the compounded medications you need from your pharmacy of choice. If a state doesn’t sign the Memorandum of Understanding, a mere 5% of the total prescription orders for any pharmacy in that state may go into interstate commerce. FDA has total discretion in the matter.
In many cases, what you or your doctor wants won’t be available inside the state. The only way to get it is to go to a leading compounding pharmacy out of state. But you may not be able to do that anymore if this provision becomes law. Or you may have to settle for an in state compounding pharmacy that is not the one you know and trust. Either way, vital compounded medications such as bioidentical estriol or customized thyroid medications could be at risk.
As we mentioned, some items in the new Senate compounding bill address earlier concerns we had and thus represent an improved version:
- The new bill doesn’t tell compounders that physician office use of their drugs can only represent 10% of sales (how would they be able to know?) or require physician reporting within a few days. But—and this is a serious “but”—all office use compounding (that is, compounding in the physician’s office in advance of a patient prescription) would have to be done by an “outsourcing facility,” which would be limited to a pre-approved list of medications.
- The bill doesn’t include time-released medications among those supposedly “difficult to compound” and therefore banned—though the bill still authorizes FDA to develop a demonstrably difficult to compound list.
- On the downside, as in the old Senate compounding bill, compounded “copies” of FDA-approved and marketed drugs would still be illegal, even if customized dosages are needed for the patient. This would enable drug companies to raise prices on already sky-high-priced drugs.
P.S.: Monsanto Rider Appears Dead
All thanks to your efforts!
Please don’t think your calls and letters don’t matter—they do. The Monsanto Protection Act has apparently been stripped from the Senate’s version of the government funding bill! You spoke out and our allies in the Senate listened.
This provision, which strips federal courts of the authority to halt the sale and planting of potentially hazardous genetically engineered crops and which was inserted at the last minute in a funding bill back in March by allies of Monsanto and other GMO companies, now appears to be history. Sen. Barbra Mikulski, chair of the Senate Appropriations Committee, said, “My promises made are promises kept. . . . There’s no reason for [the Monsanto Protection Act] to be included in a short-term CR [Continuing Resolution].”
Thanks to you and the many groups fighting alongside us, the Monsanto machine did not get their way! But now we need your help once again to protect consumer access to important individualized compounded medications. Please don’t let them make some really important compounded IV medications illegal! Someone you love may desperately need them. Please read more about this terrible provision on our website, and take action immediately!
Population Control Is The Name Of The Game.
We don’t need this.
Thank you for keeping me informed on the health issues before congress. I hope our representatives have the knowledge of health issues before signing a bill to limit our access to all health promoting substances. Thank you
Ron Rowe
This is outrageous. Hands off our natural therapies and stop with the corruption. We have had enough.
FDA has full list of many short falls, please keep FDA’s “green hands” off! Where is another Regan to cut Red Tapes off.
I expect FDA to attempt to outlaw food in hospitals. Nothing but drugs.
Dear Sirs
This will set back the Advancement in Medicine, we have managed to obtain in the last years.
If Science waits for “Medicine Based evidence”, this will take 10 to 20,
years to get to the public So patients like autistic children and chronic toxic patients will be condemned to die or get secluded in special psychiatric facilities with no hope to get cured….
by the contrary this IV vitamins have recuperated more than one of my Autistic patients, and saved some chronic patients with strange diseases.
Don’t make a mistake….look at the real science facts….don’t trust epidemiological studies
20 years……too late for many
I understand Congress is about to cut my lifeline. I was apparently born with the inability to absorb adequate amounts of vitamins and minerals from my food. but it wasn’t diagnosed until I was 40. For the past 46 yeaars, I have relied on megadoses of these supplements to keep me alive and fit. If you pass this bill to restrict access to the supplements I need, I will probably go to my reward in short order.
You are a politician, not a doctor. Please do not try to decide what is right for me and the many others in a similar position. I am an intelligent, productive citizen of this country and I believe I should be allowed to remain that way for as long as possible. Please vote against Section 503A of the FD & C Act. I want to live.
Thank you.
I get scared when politicians without medical degrees start sticking their fingers in my doctors business, leave him alone and let him do the job for which he was trained for and you were not.
Those in the AMA should study the new finding about how healthful and beneficial natural products in Nature can help and keep humans whole and healthy. Chemicals take a long time to leave the body even after their limited beneficial help. Vitamins are helpful and needed by almost every human alive today, Why do you want a law to prohibit us from treating ourselves the way we wish.
I believe that restrictions of use of vitamins and minerals are more misguided than not, and should not come from legislation but rather be science-based or practices-based. We have a good system, but we are doing some things wrong and the pressures of economic interest will continue to exaggerate some dysfunctions. Leave out these restrictions and concentrate on fixing the drug approval pipeline, please.
Senater Cornyn –
I urge you to protecct Consumers’ Right by allowing individualized coompounded medications. Do not allow the Monsanto’s to make this type of medication “illegal” !!
Many people need customized medications – many of the current drugs have far too many side effects… It is not “one size” fits all !
Thank you for voting to do the right thing.
As a senior in college, following a head-on freeway accident caused by a drunk driver trying to commit suicide, I was left to suffer from a mysterious illness for the next five years that baffled twenty-five different doctors. Finally, of all people, a nun at my parish told me that she had a friend who had a similar experience and she had a compromised immune system that left her hypersensitive to medications, foods and chemicals that never bothered her before the accident. Long story short, I started seeing holistic doctors who used nutrient IV therapy.
I went from being totally disabled, barely able to read or do math calculations,unable to work or drive….to restored health thanks to my IV therapy. It’s been 37 years, I still need an IV 1 to 3 times a year, but instead of racking up tens of thousands of wasted medical bills on futile treatments….I am well enough to travel to Europe and advance my 30-year writing career. I COULD NOT have regained or maintained my health…I would have been unable to enjoy my family and my life if not for those IV’s.
I will fight to the finish to make sure the most effective, affordable life-enhancing therapy available to me is not taken away from those of us whose quality of life depends of it !!! DON’T STAND IDLY BY ON THIS ONE PEOPLE !!!! I sure as heck am not !!!!
Please amend the new compounding bill immediately, this is wrong.
please publish what senators are sponsoring it.
please amend the new bill!!!
•The new bill doesn’t tell compounders that physician office use of their drugs can only represent 10% of sales (how would they be able to know?) or require physician reporting within a few days. But—and this is a serious “but”—all office use compounding (that is, compounding in the physician’s office in advance of a patient prescription) would have to be done by an “outsourcing facility,” which would be limited to a pre-approved list of medications.
•The bill doesn’t include time-released medications among those supposedly “difficult to compound” and therefore banned—though the bill still authorizes FDA to develop a demonstrably difficult to compound list.
•On the downside, as in the old Senate compounding bill, compounded “copies” of FDA-approved and marketed drugs would still be illegal, even if customized dosages are needed for the patient. This would enable drug companies to raise prices on already sky-high-priced drugs.
Please don’t ban IV vitamins or any natural cures. Please fight big pharma. Let drs. Use vitamins and minerals.
who keeps adding these unreasonable issues? This is over and over again. We need to find out who is behind this. What lobbyist and what representative and senators are buying into the crap. Then we go to the polls. Is it the same senators and reps?
additionally we need to know how much money these congress people are receiving for this. That is the real issue. We need the names and numbers.
Please consider the life renewing properties of vitamins and minerals on their own merit. They are often far more beneficial than any synthetic pharmaceutical drugs. The patient should be allowed a choice. Remember Hippocrates.
My wife CAN NOT absorb some synthetic drugs and it damages her health. If this bill is passed my wife will not be able to get the medicine she can absorb in her system. It is time to tell the big pharmacueticals start healing people and stop being drug pushers.
Please do not pass any bills taking away the right to receive IV vitamins and minerals, or the natural supplements. If I did not have these items, I would starve from lack of nutrition because of my many food allergies I suffer with everyday. Please I beg you to not pass this bill. If you my blood will be on your hands. Thank You Nila Calbo
Please do not pass any bills taking away the right to receive IV vitamins and minerals, or the natural supplements. If I did not have these items, I would starve from lack of nutrition because of my many food allergies I suffer with everyday. Please I beg you to not pass this bill. If you my blood will be on your hands. Thank You
The FDA clearly has proven they are not interested in the health and safety of people. Otherwise half the approved drugs wouldn’t have been approved in the first place. We can blame big pharma for this.
Let compound IV’s be legal. Let it be the Doctor’s and patient’s own business.
Totalitarianism anyone?
The government needs to stay out of medicine, schools, religion…… They need to grow up and learn to do whT is right for all people…and quit thinking they r above the law.
I respectfully demand that the bill to make IV nutrients, compounded hormones, etc be vetoed. This would be a travesty of great proportions to say nothing of a infringement of our Constitutional rights. Thank you very much for your cooperation in this matter.
Dont take away my iv vitamins.
I need these vitamins for my chronic illness.
Why. Can’t the govt stop destroying this country and keep their noses out of places it does not belong?
Why when something that is clearly unhealthy for the people they support?
This is unbelievable!!! How can congress be bought by big pharma thereby reducing the public’s options in their own health care. DO NOT PASS THIS BILL!!!!!
Please reconsider the use of nontraditional medicines. In this era of high drug costs, natural medicines meet many special needs. Patients are not cookie cutter characters. Each boy, every need is unique.
Our bodies need vitamins and minerals to survive. I highly object to this bill allowing only drug form. It just wipes out any natural aid to those who need it whilst only making Big Pharma richer and more in control. Druds are drugs and Big Pharma can keep them but natural resources should be with those who know what they are doing and Big Pharma is not it.
I completely oppose this bill. Its obviously intended to sweep more money to the pharmaceutical companies.
THANK YOU for keeping us updated and educated on these issues! Everyone needs to take these attacks seriously and take action or we will certainly loose our right to choose what supplements we wish to take. Enough is enough already! Don’t just sit there! We’ve got to be proactive! Spread the word! Get busy! Write to your representatives and educate them! Let them know they are being watched with regards to this issue and how they vote.
Protect our freedom to choose!
Please don’t let some really important compounded IV medications illegal!
Please let those who new medication have it….There maybe a day you need it
Why does ANH support compounding pharmacies so strongly? These companies are not much different than Big Pharma, except in scale. Their raw materials often are purchased directly from Big Pharma. I don’t get it. Please explain.
So sad for people out there including myself who need these special treatments/medications to try and love normal. We cannot allow these freedoms to be stripped from us!
by natural means just like your website nevertheless you need to examine your spelling with several of this blogposts. A number of them are rife together with punctuational problems so i to uncover the item quite irritating to express to the fact on the flip side I am going to undoubtedly revisit again.
People like myself rely on nutritional IV’s for survival. I had a bowel resection and suffer from malabsorption because of it. Other’s have inability to get enough nutrients because of severe allergies to many foods, therefore, are deficient in many vitamins and minerals. Please vote to help us whom rely on these IV’s for survival.
Sincerely,
A Swire
This is a Wonderful Website
Please do not interfere and please allow us the freedom to take vitamins.
What gives poloticians the right to tell people what they can or cannot use or take into their bodies.? What happened to ‘Human Rights’. I use only supplements, vitamins and foods/herbs to keep me healthy. I haven’t consulted a doctor for years.
What is the results of this bill? Did it get passed with such abuse included in it?