The FDA listens to ANH-USA members and other critics in final rule.
The agency, in its final rule governing the removal of medicines from a list of permitted compounded drugs, has agreed to notify interested parties in advance, as required by law. This is a victory, in that the agency’s original proposal from 2014 was to drop public notification, despite notification being required by the government’s standard rulemaking procedure.
The aim of the 2014 proposal was clearly to drop public input, and at least for now, your efforts and those of our allies have helped to stop this. Whether the FDA will try again is uncertain. It says that its decision is made “at this time,” which clearly signals that it may only be a temporary retreat.
Temporary or not, it is good news, and it is in addition to the other good news we have already reported on—that the agency is defining “transdermal and topical delivery systems,” which are likely to be banned from compounding, to exclude creams and gels, but instead to include patches only.
As we pointed out, creams are absolutely essential to the proper delivery of many natural hormones among other drugs, so we will be watching this very closely. With luck, the FDA will not go after creams in the future. This is, however, far from certain.
Big Pharma is moving into the bioidentical hormone area. Although it does not like selling creams, it likes selling patches. This is not necessarily in the best interest of consumers, because patches contain penetrating agents that pose their own risks. But if Big Pharma has control of bioidentical hormone tablets and patches, it then might move against creams through the FDA. In our efforts to protect creams, we have had the help of many allies, and we would especially like to thank our friends at the International Association of Compounding Pharmacists for their hard work on these issues.
Using arcane or overly broad language, or burying important information in long, complex documents—all of these are familiar FDA tactics. Remember, this is how the agency tried to impose a backdoor ban on natural folate. For that reason, we and our allies have to maintain constant vigilance.
There is some bad news, too: adenosine monophosphate (AMP), -diphosphate, and -triphosphate have been banned from compounding.
AMP is currently available in supplement form, but unfortunately the most robust benefits of this substance have been demonstrated when it is injected intramuscularly (see below). As far as we can tell, injectable AMP was only available through compounding pharmacies, meaning that doctors and patients will no longer be able to use this natural remedy.
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 also indicate its potential effectiveness in the treatment of chronic fatigue syndrome and muscle fatigue. One patient told us:
I have been using AMP [under the care of a natural physician because 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.
We believe the FDA is trying to restrict compounding pharmacies to protect their allies in Big Pharma, and the attack on compounded versions of drugs has only started. Congress does not understand these kinds of technical issues, so the involvement of the public is crucial.
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