The U.S. Food and Drug Administration (FDA) is currently considering a petition filed by a pharmaceutical company that is requesting a ban on dietary supplements containing pyridoxal 5′-phosphate (P5P), a bio-active and natural form of vitamin B6.
The pending petition by Medicure Pharma admits that P5P is a naturally occurring molecule in the vitamin B6 family that qualifies as a dietary supplement. Medicure’s point of contention is that P5P in dietary supplements will infringe on their profits from a drug they are currently developing, which includes P5P as an active ingredient!
With surprising candidness, Medicure states in their petition, "Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs, because many people may choose to purchase the supplements rather than the drugs".
I invite you to join me in telling the FDA that the public does not support this ban. You can do this simply and easily by clicking on the following link to a page on the website for the Alliance for Natural Health USA, a health fredom organization I am a member of.
BUT BEFORE YOU CLICK, please first read the rest of this post.
I propose that you replace the editable version of the letter ANH will provide with this more expanded and blunt version that I sent to the FDA. Just copy the following and replace their proposed letter with this version.
This letter is to voice my strong opposition to Medicure Pharma’s so-called Citizen’s Petition Request to Ban Pyridoxal 5′-Phosphate as a Dietary Supplement (FDA-2007P-0410).
Medicure has requested that the FDA ban the marketing of dietary supplements containing pyridoxal 5′-phosphate (P5P) because Medicure has a drug in development whose active ingredient is P5P. Medicure suggests that P5P is a new dietary ingredient, which is subject to pre-market approval requirements. Nothing could be further from the truth and they know it, because within its own documents, Medicure admits that P5P is a naturally occurring molecule, a part of the Vitamin B6 family. In other words, they know that in fact P5P has been a part of the human diet since the beginning of our species.
Vitamin B6 is essential to good health. We would all die without it. Moreover our bodies must convert B6 into the P5P form in order to use it and different people’s bodies do this with varying levels of efficiency. Medicure is essentially trying to turn an essential part of our diet (in this case, P5P), into a monopoly drug. No drug company should ever be given this power by the U.S. government!
This is a bold attempt by Medicure to manipulate the FDA into disregarding the 1994 DSHEA regulations that protect nutritional supplements from exactly this kind of assault.
For all of these reasons I urge the FDA in the strongest way possible to reject this outrageous request. Drug development cannot not be allowed in any way to restrict my access to P5P as a food supplement for the sake of their drug development efforts.
As an American who includes dietary supplements in my approach to health and wellness — as my personal health reform plan — I require that you place the rights of Americans ahead of the designs of industry and protect my freedom to access dietary supplements. Medicure’s so-called "Citizen’s Petition" is a sham that you must reject.
This is a direct assault by the pharmaceutical industry on health freedom, and therefore upon individual liberty. The pharmaceutical industry is trying to pressure government into making their profits more important than government’s responsibility to preserve individual freedom. Medicure and other pharmaceutical companies like it are engaging in outrageous attempts to manipulate you, my government, into endorsing a socially irresponsible version of capitalism. You simply must not allow this industry to further erode our health freedom or reinforce socially irresponsible expressions of capitalism.
I therefore am also asking both the FDA and Congress to issue a public statement stating in no uncertain terms they will not endorse this disturbing trend by drug companies to convert widely available food and supplement items into monopoly prescription drugs.
I and millions like me are watching you. We expect you to reject this manipulation attempt and others like it.
I have seen to it that a copy of this communication has been forwarded to my senators and representative. I am watching closely to see if you and they support or oppose health freedom and socially responsible capitalism. If my elected officials oppose either of these they can be certain that as one of their I will vote against them in the next election.