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Here We Go Again: FDA Defies Congress

Here We Go Again: FDA Defies Congress

And hobbles your doctor. Action Alert!
In the waning days of 2016, the US Food and Drug Administration (FDA) ignored the expressed will of Congress. The agency completed a “guidance” document that prohibits traditional compounding pharmacies from stocking doctors’ offices with custom drugs.
In December 2015, Congress included a provision in an end-of-the-year spending bill ordering the FDA to issue a guidance document clarifying how physicians and compounding pharmacists could continue the “office use” of drugs. These are custom drugs that a doctor keeps on hand for immediate treatment use. Congress could not have been clearer: the agency was not to forbid office use. The FDA has now answered—by ignoring it.
The FDA now wants the doctor to have to prescribe the drug—to have it compounded separately for each patient, and then administered on follow up visit. This is not only dangerous for patients who need immediate treatment. It also vastly increases the cost of the drug, wastes patient and doctor time, and is gross interference with the practice of medicine, which is supposed to be regulated by the states, not the federal government.
It’s increasingly obvious the FDA is a rogue agency unaccountable to the American people and the elected officials chosen to represent them. The FDA’s action is the latest evidence to support our long-held contention that the agency’s real goal is to eliminate traditional compounding pharmacies altogether. We think the agency wants to force all traditional facilities to register as outsourcing facilities, because under recent legislation, what can be compounded at outsourcing facilities is completely at the FDA’s whim, and can also be very narrowly defined. We can also expect the surviving pharmacies to be owned by Big Pharma.
We must not let the agency get away with this.
Action Alert! Write to Congress and voice your disapproval of the FDA’s thumbing its nose at Congress—and offer your support for compounding pharamacies.
Other articles in this week’s Pulse of Natural Health:
Worse than Zika, but Ignored. Why?
Mumps Outbreak: The Real Cause

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16 thoughts on “Here We Go Again: FDA Defies Congress

  • barbarakelly


  • Jeff

    What about negative medical events of compounded drugs? Where are these reported? FDA regulated drugs have problems, what controls compounded drugs? What programs proves their effectiveness?
    How about a discussion of compounded drug issues. After all, if FDA regulated drugs produce negative outcomes, then why wouldn’t compounded drugs?

    • Mike+Ike

      The article doesn’t discuss negative events from compounded drugs because they are EXTREMELY RARE, Jeff. In fact, compounding pharmacies exist mainly so that doctors and patients have access to drugs without or reduced preservatives and additives that CAUSE ADVERSE REACTIONS in some patients. They also compound vitamins, minerals and hormones that are inherently safer than drugs. The FDA regulates compounding pharmacy facilities already for safety, Jeff. The FDA’s agenda is Big Pharma’s agenda. They don’t need to dictate what these pharmacies compound, what doctors prescribe, and what patients need in the way of compounds with a proven safety record, just because they’re not patented by Pfizer, et al

      • ARJAY

        The FDA also said that walnuts are a drug (not a food) if the label on the package shows ANY health benefits. Walnuts have NOT BEEN PROVEN SAFE as a drug!
        Really, FDA?!?!
        People have been eating walnuts for CENTURIES, but not proven SAFE?!?!?!?!
        CONFLICT of INTEREST, if I ever heard of one!!!!

    • ca_ssandra

      Jeff- Per reporting from ANH a while back, the FDA deliberately ignored the problems with one compounding pharmacy in order to damage the entire industry. The dangers of approved drugs are so vastly pervasive compared to a few errors with compounded drugs that it is mind-boggling that the FDA is trying to destroy compounding, altho it is obvious their purpose is to eliminate ALL competition for Big Pharma, sort of like organized crime.

      • Bruce Stewart

        The problem with the compounding pharmacy was very rare and really had nothing to do with the compounding but poor quality control in their very large operation. The compounding pharmacies I am aware of make one prescription at a time. Compounding is very necessary because we are all different in our genetic makeup and there is no one-size-fits-all drug. Female hormone replacement therapy is one of the best examples. Sorry lady but you have to take this much estrogen and progesterone because that’s how the FDA approved the pills.

  • Tom

    Jeff, what about pharma shills like yourself? Why should the the pharmaceutical companies be allowed to mislead the public by paying people to put fake comments on the internet?

  • archer

    Just in please go to the Autism Action Network on 1/10/17 Robert F Kennedy, Jr has been asked by President elect Trump to chair a commission on vaccine safety and scientific integrity.
    This is phenomenal news there may be a letter at the site (newsletter members get it in their inbox 🙂 people can send to support President elect Trump please fill it out and send your big thanks.

  • M. "Wyatt" Howell

    https://uploads.disquscdn.com/images/5c115cdb9fa0a712104c6f5a5a36cbf7a2a0abf2ffe152b8b6d53a93d6dbb316.jpg What happens when Congress has been a group of brain-dead criminals for so long. No one takes them seriously, because they are mostly pansies (not all, but most). The FDA is also one of those agencies that have no Constitutional constraints. Why not remove the Director ? Why not clean house ?
    This is a slap in the face to every American. …not to mention we need a completely new conservative, morally balanced Congress. Picture is how FDA tests for drugs and food toxins.

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