Agency: Food and Drug Administration (FDA)
Document Type: Rulemaking
Title: Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
Document ID: FDA-2018-N-4845-0001
Comment: The National Health Federation (NHF) is the World’s oldest health-freedom organization and supports the right of individuals to select for themselves what treatment and prevention modalities and substances they decide that they need to maintain their health.
The current attempt by the Food and Drug Administration to limit those individual health rights of Americans to compounded pharmaceutical preparations through FDA’s draft rule is both unsupported in the law and in science.
None of the following 26 ingredients currently being compounded by pharmacists – but which would become disfavored once the draft rule becomes final – are dangerous or harmful to patients. Indeed, they are beneficial and in many instances life-saving – as are those hundreds of other compounds that the FDA has refused to even evaluate.
The FDA unfortunately has a history of favoring pharmaceutical preparations created and marketed by large corporations over those natural remedies that in many instances perform the same function as the more-expensive and even more-dangerous pharmaceutical preparations. Such a history has had the sad and unfortunate effect of harming consumers’ health and finances. NHF rather suspects that the cozy relationship FDA has with the pharmaceutical giants, including the “revolving door” practice of FDA leadership retiring into Big Pharma consultancies and even directorships, has a large part to play in the FDA’s unwarranted attacks and restrictions upon the natural-industry competitors to those pharmaceutical corporations.
So, too, here, with this proposed rulemaking. There is absolutely no reason whatsoever for the FDA to eliminate hundreds of healthful compounds that have already been used for many years with no ill effects.
FDA has no legal basis for taking such action, has not acted within the law and the U.S. Constitution in promulgating its rules here, and in fact is acting against the direct and stated intention of Congress in eliminating these natural substances from compounding pharmacies.
The FDA’s current position that “if there is an approved pharmaceutical equivalent that will address a patient’s condition, then a compounded ingredient is not needed,” is unsupported in fact. If anything is clear, it is that humans are biochemical individuals. What perfectly sensible medication might work for one person, may very well be a poison to others, or simply ineffective. Besides, has not the FDA ever heard of the truism “Don’t put all of your eggs in one basket”? So, what happens when the disease being treated evolves around the “one, true & approved” FDA medication? And there is nothing else to fall back upon? Is the FDA really so terribly sure that it has all of the answers right now to the diseases that might infest humanity in ten years, twenty years, or a century?
This is a dangerous, high-stakes game that FDA now plays in betting all of its money on one hand. And if FDA’s bet on the one and true pharmaceutical preparation is wrong, then who pays the cost? We all do, the country does, and possibly there will be no recovery whatsoever.
NHF respectfully submits to the FDA that a healthier society will result from having as many treatment choices available to patients as possible. The proposed rulemaking should be withdrawn and rethought in light of our comments here as well as those many other thoughtful comments submitted to the Agency.