On Saturday the compounding bill passed the House by voice vote on motion to suspend the rules. The Senate could vote on it as early as today. URGENT Action Alert!
As we reported last week, the compounding pharmacy bill we had been warning you about was scrapped because of the outcry from consumers like you. The new bill, HR.3204, the so-called Drug Quality and Security Act, was passed by the House of Representatives in a voice vote.
This means of course that there is no record of anybody’s specific vote. The chances of changing it in the Senate now are very low, but they could take up the bill under unanimous consent and voice vote as soon as today or perhaps tomorrow, so please write your senators one more time—and phone them as well!—because miracles do sometimes happen.
Let’s keep in mind the reasons why this bill, despite numerous improvements, is still so bad:
- The new bill contains sections that would ban doctors from prescribing compounded nutrients delivered intravenously unless they are on a pre-approved list, have a USP monograph, or are components of FDA-approved drugs. Imagine: your doctor cannot give you an IV containing natural vitamins and minerals unless these ingredients happen to be in some FDA approved drug! Moreover, such IVs are some of the best tools that integrative doctors have.
- The language about needing to have a USP monograph or being components of FDA-approved drugs came from an old section of the Food, Drug, and Cosmetics Act that had been deemed invalid by federal courts, so in 47 states, physicians have recently had the freedom to prescribe and dispense compounded nutrients of their choice by IV. If the new bill passes, this will become illegal in all 50 states, at least until another legal challenge can be mounted.
- The bill makes the falsification of a compounded prescription a federal criminal act. The trouble with this is that states are supposed to have jurisdiction over the practice of medicine. This will take the federal government even further into the doctor’s office.
- Also in this new bill, compounded “copies” of FDA-approved and marketed drugs would still be considered illegal. This would enable drug companies to raise prices on some drugs to astronomical levels.
As the Senate prepares to pass this, these very bad provisions notwithstanding, we should remember that we were successful in changing many troubling elements of the original Senate bill. For example:
- The previous version of the bill would have allowed the FDA to identify bulk ingredients not “suitable for compounding” based on “public health concerns” even if they have a USP monograph. We managed to strike the language that a USP monograph would not provide protection. Since important ingredients like estriol have a USP monograph, this change will ensure that estriol is protected from the FDA and remains available for the millions of women who rely on it! This was a major victory.
- We ensured that compounders could make non-standardized dosages of drugs so you can have the right dosages instead of cutting pills in half.
- The new version of the bill maintains the standard we inserted (from current law) for “difficult to compound.” Previously the bill had no standard, giving the FDA too much flexibility to ban whatever they wanted. It also doesn’t include time-released medications among those supposedly “difficult to compound” and therefore banned.
- The provision that compounders needed to perform random controlled trials in order to meet a “safety and efficacy” standard was removed. This was a backdoor approach to banning compounded medicines, because everyone knows that no one could afford to pay for those trials of non-patentable drugs, and RCTs in any case are inappropriate for individualized medicine.
- We were also able to remove the requirement from the previous version of the Senate bill that doctors must substantiate the need for a compounded prescription.
- And the bill no longer sets up the impossible to measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales or require physician reporting within a few days.
We will develop a strategy for how to deal with the remaining problems in the bill if the Senate passes it as expected. As noted above, this will probably involve challenging some of it in court.
URGENT Action Alert! (1) Please send your senators another Action Alert email, and ask them to amend the Senate compounding bill immediately. Then (2) PHONE your senators on the off chance that someone is still there—use our Action Alert for your talking points. Most senatorial staffers are out since the government has shut down, so when you phone, if you don’t speak to someone in the senator’s office, call back again when the government opens back up. We cannot stress how urgent this is—please take action TODAY!
stop infringing on the rights you claim to be protecting. !!!!
Vitamin C is used to remove toxins in the hospital. Many will die if vitamin C and other vitamins can no longer be used intravenously. That would be a form of genicide.
When will government get out of our personal choices as to how we take care of our health. Bill’s like this just invade on our personal freedom to take care of our health in a way we feel fit. Of course, we all know where bill’s like this come from. Special interests like Big Prarma that don’t wan’t competition from natural medical. And these polititions in their pockets ought to be run out of office. It is my body, and I will take care of it as I feel fit. I wan’t my choices, and the government should not limit them.
Please stop this bill. Senator we need freedom not restrictions that benefit pharmacy companies.
I have been writing each time this is necessary to save my life and the lives of others who use this form of medicine by personal choice. Why this is even any issue is beyond me to comprehend that we as individuals no longer have the personal right to make our personal choices for our bodies!! I find this a disgrace that we are treated less then animals without a voice!
Lets get real here and value the life source that gives our lives there per source of living well and remaining healthy!!
Thank You….Ditmitria Letsos-Davidson
Yes, my son would have been left to deteriorate from black mold toxicity on traditional pharmaceuticals. If it were not for integrative health physicians and IV compound medicine we truly do not believe he would have survived.
I feel strongly that this flawed bill should not become law. It has the stamp of Pharma all over it. It has become clear over the past few decades that medicine as it is practiced today is a very flawed science. Orthodox medical practice is brilliant at treating emergent conditions, but has very little to offer patients with chronic illnesses. Many patients have had to cure themselves with the help of creative doctors by researching and applying remedies outside the orthodox medical box. How can you take this away from them, when no effective alternative may be available?
Ever since Western medicine realized that intelligent people actually used alternative methods of treating themselves, standard practitioners wanted to control them even though they know little of nothing of the techniques and indications. Macular degeneration is a prime example. I have studies at least six persons who have benefited by compounded medicines when they were totally left to go blind by very highly trained specialists who called them incurable. It is safe and fairly easy to boot, and costly. I do not want these persons to tell me what does and does not work.
I meant “not costly.”
freedom of information on heath matters is very important
This is a negative decision, and the Senate must correct it. It is serious in its potential effects on health care.
Your Newsletters and articles are an absolute must — so valuable for keeping readers abreast of issues that demand our immediate participation.Thank you for all you do. Now we need to do our part.
Please amend the Senate compounding bill immediately. I use the compounding cream daily and my hormones are finally normal. I think like a normal person for the first time in two decades!
Do not homoginize and monopolize our health information.
Please do not take away an effective alternative compounded medication that is working for my back pain. I also use several other compounded meds that I would not otherwise be able to obtain. None are paid for by my insurance as it is not on my Medicare Part D “list” thanks to the FDA and the government advise from the AMA. Senator Durbin, you should stick to bills that you have personal knowledge of and not cater to Big Pharma.
Dear Senator xxxxxxxxx,,
Please amend the new Compounding Pharmacy bill to remove all the unnecessary restrictions that would limit my health freedom. Stricter sanitation standards should be all that is required for now. Compounding pharmacies save the U.S. healthcare system, because users of such medications are proactive in caring for their health and not a drain on the system. Most health insurance companies don’t cover compounded medications anyway so this is just a tactic by the pharmaceutical corporations to use their revolving door buddies in the FDA to enlarge their monopoly on medicine.
Thank you for your assistance on this matter. Thank you!
Sincerely,
Please stay out of peoples FREEDOM OF CHOICE in using safe alternative choices for treating their OWN BODIES. Please repeal the bill that makes compounding illegal. In my experience our Doctors DO NOT KNOW or HAVE the TIME to research what works for the INDIVIDUAL Patient therefore we as individuals should be able to seek out remedies that WORK and not have them illegal because the DRUG COMPANIES want to make MORE $$$. They do NOT care about the individual patient…they only care about the BOTTON LINE $$$!!!.
I am a cancer survivor please, pay attention to this matter as it is crucial to my to my health and well being. Without IV nutrition or Bio-identical hormone replace treatment my life is not worth living. My doctors rescued me from depression and chronic fatigue. I have a 12 year old child that I want to give her the healthiest possible mother that I can. She nearly lost me to cancer and later to depression and fatigue. I was practically bed ridden for an entire year after chemo unable to function normally. Now, I can cook her meals, drive her to school, take her to the library, be active in the community, work on family projects together, and most importantly; she sees me happy. I did not hear her laugh for almost two years due to my condition but, she does now, because she got her mom back.