The FDA Appears to Be Breaking the Law in Its Continuing Campaign against Compounding

May 12, 2015
Category: Reform Healthcare

The agency seeks to remove a safe and useful compounded drug from the market without any public input. Action Alerts!
Over the last year, ANH-USA has been paying close attention to new rules that are in the process of being drafted by the FDA concerning compounded drugs—especially those rules which, if enacted, would severely limit consumer access to important compounded medications.
Recent actions by the FDA’s Compounding Advisory Committee indicate that adenosine monophosphate (AMP) could be next on the FDA’s chopping block. What’s worse is that they could be removing this and other compounds from the market illegally—because there would be no public comment period.
AMP is made naturally in every cell of the body as a byproduct of the metabolic process. When injected intramuscularly, the body converts AMP to ATP (adenosine triphosphate, the “energy molecule” which is produced by our cells’ mitochondria), where it is used as an immediate and safe form of energy.
AMP is used by integrative doctors for a number of purposes. It has been shown to be an effective treatment for multiple sclerosis and herpes labialis (cold sores). Testimonials show the effectiveness of AMP in the treatment of chronic fatigue and muscle fatigue. One patient from Dr. Jonathan Wright’s Tahoma Clinic told ANH-USA:

I have been using AMP [as I] suffer from chronic fatigue and muscle fatigue when carrying out simple tasks like hanging out the wash, brushing my teeth and making the bed.…[AMP] provides significant relief from muscle fatigue. It doesn’t take away all fatigue but it helps me to function and do tasks that I would struggle with otherwise.

Given the multiple uses and benefits of this treatment, why would the FDA seek to remove AMP from the market?
In 1997, the FDA Modernization Act called for the establishment of a list of drugs that have been withdrawn or removed from the market because they “have been found to be unsafe or not effective.” Drugs on this list would not be able to be compounded. In 1998-99, the FDA proposed and finalized an initial list of compounds for the Withdrawn or Removed list, which included adenosine phosphate. Documents from the Compounding Advisory Committee meeting at the time show that there was no safety concern with adenosine phosphate—it seems to have been included on the list because the Compounding Committee concluded that adenosine phosphate was not effective as an anti-inflammatory and a vasodilator. The committee’s discussion, as far as we can tell, did not include any mention of other therapeutic uses of adenosine phosphate or AMP.
Last year, the FDA published a proposed rulemaking and solicited public comments on a number of revisions to the Withdrawn or Removed list. One comment sought clarity on the list’s entry on adenosine phosphate: did the listing for “adenosine phosphate” include all three forms (mono-, di-, and triphosphate)? To answer this question, the FDA once again sought the advice of the Compounding Advisory Committee. The Committee concluded that the entry for adenosine phosphate should be amended to reflect that all three forms of the compound are included and may not be compounded.
It is not clear yet what the FDA will do with this recommendation. Normal procedure dictates, however, that any new inclusion on the Withdrawn or Removed list requires a proposed rulemaking so the public and other stakeholders can weigh in. If the FDA wants to include three forms of adenosine phosphate on its list, then it must go through the proper channels and give the public a chance to provide input. To our knowledge, no such rulemaking has been proposed for including AMP on the list following the Compounding Committee’s recommendation, leaving no option for the public to voice their concerns.
Apparently the FDA views public involvement on these matters as an unnecessary roadblock. Last year, the FDA proposed that future additions to the Withdrawn or Removed list not go through the rulemaking process at all, shutting out the public from having any input regarding which compounds are added to the list.
This strikes us as particularly sneaky—killing two birds (removing a helpful supplement, and keeping the public in the dark about it) with one illegal stone. The proposed rule to eliminate the public from this process has not yet been completed, so the FDA is legally required to respond to public comments on the rule and issue a revised, proposed final draft of the rule. It is therefore still illegal for the FDA to add AMP to the Withdrawn or Removed list without going through a proposed rulemaking.
We must not let the FDA and the Compounding Advisory Committee, which already have clear biases against compounding, remove important treatments from the market, especially without first going through a formal, public process.
Action Alert! Tell the FDA that they should not remove the public from decisions over what should be included on the Withdrawn or Removed list. The public has a right to voice concerns about losing access to important treatments. Please send your message immediately.
Take-Action
Action Alert! Write to the FDA and tell them to preserve consumer access to AMP, a treatment that has no safety concerns and has clear and demonstrable benefits to patients. Please send your message immediately.
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4 responses to “The FDA Appears to Be Breaking the Law in Its Continuing Campaign against Compounding”

  1. Robert Cruder says:

    TriCare is investigating compounding and may disallow payment if it is not reformed.
    A compounding pharmacy, perhaps in league with the provider can duplicate a mass-production pharmaceutical that has a fixed negotiated price with one that provides no therapeutic advantage but costs far more. The provider and the pharmacy profit and the taxpayer is cheated.
    This should properly be called fraud against the country and it cannot be hidden behind the patient’s freedom of choice. Patients do what the provider advises and thereby contribute to the problem.
    Even if your copay is small, question the prescription of a compounded product. Quite possibly the purity and consistency of dosage are worse than the mass-produced product. A few patients are still suffering the effects of compounded and contaminated spinal injectables.

    • Dr.S says:

      In my experience, this rarely happens. Insurance reimbursement for compounded medications is so poor that it’s hardly worth the effort to try to get reimbursed for it. Most of the time, compounded medications are for something either not commercially available (certain hormones, combinations of medications, etc), or in a form that isn’t commercially available (dye-free, lactose-free, liquid, etc).
      It’s possible that there may be bad actors like what you describe out there, but the vast majority is for prescriptions that are unavailable through standard channels.
      The contaminated spinal injectables you refer to were from a single pharmacy in Massachusetts that had a long history of poor practices and had been breaking the state rules for compounding but the rules were not being enforced. That pharmacy should have been shut down long before. The doctors using their products were using them because they were less expensive than the commercial products, so this example has little to do with your original thesis.
      However, making more rules will do nothing if the rules aren’t being enforced. Adding more rules adds to the cost of the compounders who are following the rules and ends up punishing the consumers who rely on the reputable compounders since they end up paying more for the prescriptions they need..

  2. karatekaforlife says:

    We use a small, independent and trustworthy provider of compounded pharmaceuticals. Without this service, our medication would have to purchased in a large, uniform dosage, and dissolved at home, into the proper dosage. Without compounding, pharmacies are nothing more than dispensaries.

  3. Wendy Allen says:

    I have MS…took a supplement that helped ATP. That did not not help when I was low in vitamins/good oils, Vit B12 shot, Amour thyroid, bioidentical hormones etc. The cell needs to be made right to work right. Celiac may lower nutrients absorbed in the intestines so cells are not made right. Correcting the Celiac by eating no gluten/dairy/soy/sugar/GMO and taking vitamins/good oils, LDN, detoxing may help MS people more than just a supplement to increase ATP.

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