But we can stop it now. Action Alert!
For some time now we have been explaining how the FDA appears to be trying to put compounding pharmacies out of business in order to boost the profits of its major client, the pharmaceutical industry. It doesn’t seem to matter to the agency that you will no longer be able to get critically important drugs, or your medications in the right form. All that seems to matter is Big Pharma profits.
We recently also described how part of this same process is not allowing doctors to buy drugs, primarily from compounding pharmacies, for “office use.”
This means you have to go to a doctor, be told that you need a B12 shot, go home while the doctor orders the B12, go back for the shot, and pay four to five times what the shot previously cost—on top of all the time, including recovery time, wasted. This alone shows how completely hypocritical the FDA is about reducing medical costs.
It is possible to fight back, primarily through Congress. In December 2015, our allies in Congress included a provision in an end-of-the-year spending bill that, among other things, directed the FDA to issue a guidance document clarifying how physicians and compounding pharmacists could continue “office use.” The language could not have been clearer: the agency was not to forbid “office use.”
Following Congress’ rebuke, the FDA did indeed release guidance documents pertaining to office use—but outrageously, the agency stated once again that traditional pharmacies cannot engage in office use. In other words, the FDA flagrantly defied Congress’ directive.
Even more unbelievably, the agency issued another guidance document that creates an exception to this ban. Traditional compounding pharmacies that are owned by a hospital or health system (which the FDA defines as a collection of hospitals owned and operated by the same entity) may continue to make customized medications without an individual prescription. They get “office use,” but no other doctors do.
The FDA discriminating in favor of hospital companies and handing them financial windfalls is nothing new. As we’ve noted in our coverage of laboratory developed tests (LDTs), we think part of the reason the FDA has been so hostile to innovators like Theranos is to protect the financial monopolies hospitals and a few large companies have over medical testing.
The creation of local hospital monopolies, probably influenced by campaign gifts and the like, pervades the entire government’s approach to healthcare. Medicare pays out more to doctors affiliated with hospitals, providing very strong direct government incentives for the creation of local monopolies centered on hospital-employed MDs (even though many don’t actually work on the hospitals’ premises). This also helps keep medical costs high.
It is time for the FDA to be held accountable for ignoring the expressed will of Congress, not to mention doctors and millions of patients who need their medications. There is currently an effort in the House of Representatives to withhold funding from the FDA until the agency fixes the problems it has created in the compounding industry, restricting consumer access to this vital branch of medicine. Perhaps the FDA will listen when its budget is in sufficient jeopardy.
Action Alert! Write to your representative in the House and urge him or her to support the FY 2017 appropriations language that would withhold funding from the FDA until the agency states how it will allow “office use” of compounded medicines to continue, and how the compounding of supplements will move forward and at reasonable prices. Please send your message immediately.
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9 thoughts on “FDA Defies Congress, Slips Money to Hospitals, and Stiffs Consumers”
Heck The What can one expect of the slime ball Bureaucrats, Politicians and so called new media for all they want is the Payola to grease their palms. The FDA for Payola from the Pharmaceuticals approves high profit, high price poison drugs that murder over 100,000 people each year and you are total guns are bad. Gun deaths are a piker in comparison to the murder for profit of the FDA and Pharmaceuticals. Of Course that does not include the thousands of toxic poison lace into the processed food that make you sick. Did you know that we hundreds of corrupt Federal Agencies that these slime ball Politicians installed to rule and I do mean rule and you have no rights for they are empowered to rob you of your money, steal your property and if you standup they can murder you with not recourse and all so the slime ball politicians can get the payola that greases their palms.
The FDA works for the president. As they say the fish smells from the head. President Obama could fix this by a single phone call to the head of the FDA, who works for him. Of course he will never make that call.
As one of 11 million + that has no safe asthma inhalers anymore, using compounded drops in the distilled water bottle cup attached to my liquid oxygen tank is the only way to get either a steroid or cromlyn without the preservatives that not just inflame but cause life threatening chemically induced pneumonitis plus severe exacerbations of my occupational asthma. (reduced cost is a savings of over $500 but who cares about reducing health care costs). The FDA DOES NOT KNOW WE EXIST , EVEN THOUGH THE MEDICAL COMMUNITY HAS FOR 30 YEARS NOW .as we are excluded from clinical trials for those with a heart condition cannot be in one for an asthma drug and those with chemical/toxic injuries do from day one as the heart over works to compensate. One has to be monitored by a cardiologist in order for pulmonologist to treat. and the FDA says ozone is good to breathe and has pushed concentrators and ionizing air purifiers since 2002 when they were near banning all ,So one has to use compressed air (green bottles) or liquid oxygen but life threatening also from low levels that inflame in minutes. Among us are the 2 million left to die after 9/11/01 in NYC and the nearly 1 million of us who already existed found ourselves I the midst of a real battle for life and treatment. I am nota doctor, but have seem some of the leading ones in the field since inured 1/10/89 and am living proof that with treatment accepted by the medical community one does not die in 3 to 5 years. as one once did…… and now is Linda Joy Adams
FDA officials seemingly onoing and deliberate strategies to put compounding pharmacies out of business also give the appearance that they ignore the fact that office use of compounded drugs may prevent or curtail the use of controlled drugs. For example, compounded methylcobalamin or hydroxocobalamin is a medically indicated treatment for neuropathy. Left untreated, many neuropathy patients will be forced to use controlled drugs to treat their pain. It begs the question of whether or not the FDA is precipitating prescribing of controlled drugs that may llead to addiction.
Interestingly, hydroxocobalamin is also an antidote for cyanide poisoning. It is on the WHO’s vital drug list and may be included in certain stockpiles. Unfortunately, the sole source generic contains parabens, and the only other commercially manufactured source received orphan drug status from the FDA and retails for hundreds of dollars per 5mL dose.
For about 25 years, I have been using herbs, oils, teas, vitamins. I’ve been getting acupuncture weekly, for about 2 1/2 years, for a back back problem. At 68, I have no health issues and my blood pressure runs about 90/60. Please help stop this, and all, government invasions into my health program.
Agree with you Cheryl! Keep healthy so we don’t need FDA. I cure my long term Irritable Bowel Syndrome disease without any FDA approved drugs. (actually these FDA approved drugs nearly kill me, that why i turn my back on conventional medicine) . I’m 50 and so happy much better health than when I was 20s.
Thank you. I had IBS and diverticulitis. Also, cured. Of course, getting divorced also helped a lot, with that problem. Stay healthy and keep up the good fight. We ARE winning.
Terminate the FDA! It’s just one of the many useless alphabet agencies. Let the lawsuits begin. When big pharma looses a few of them, then they’ll start paying attention to doing the right thing.
It would be nice if they were simply a “useless alphabet agency.” What they are, in fact, is Big Pharma’s primary dictatorial enforcement arm. Their objective is to keep the American public sick, hence reliant upon allopathic medicine.
The FDA has threatened family-owned orchards with utter destruction for advertising that organic fruit has nutritional benefits (these small fruit growers are forbidden to even LINK to scientific studies showing what natural foods are proven to be good for).
The FDA has denied producers of salmon, avocados, and grass-fed meat the right to say that their products contain “healthy” fats or oils because the FDA “deems” fat to be bad for us (while permitting high sugar products like Fruit Loops to place the word “healthy” on their packaging, because many such sugary confections are low in fat.
The FDA has recently announced their long awaited “deeming” rules for electronic cigarettes, which will effectively destroy a $4 billion industry which is currently saving millions of lives, (they are handing it over to Big Tobacco, who are costing us billions yearly in medical costs, as well as millions of lives). Clearly the growth in popularity of a product which is weaning Americans off combustible tobacco products (and has killed no one) bites deeply into the paychecks of not only Big Tobacco, but Big Pharma and the TLA “health” agencies as well (ACS, ALA, AMA, etc.)
The FDA is doing all this while approving big ticket foods and drugs like aspartame, GMO products, and Vioxx for those monster corporations able to pay for approval.
Big Pharma will not lose the lawsuits you speak of, Centurion, because they are too big to fail, and purveyors of allopathic medicine have been granted broad immunity from prosecution for the harm they do.