"Tell the FDA that You Oppose The Drug Company Petition To Ban P5P, The Natural And Bio-available Form Of Vitamin B6!
P5P Is The Natural Form of B6 That Your Body Actually Uses. ALL Other Forms OF B6 Must Be Converted To P5P To Use Them. You Will Die Without P5P. It Naturally Occurs in Food. Do Not Let The Drug Industry Appropriate It And Convert It Into A High Priced Prescription Drug.
The US Food and Drug Administration (FDA) is considering a petition filed by a pharmaceutical company, Medicure Pharma. The company is requesting a ban on dietary supplements containing pyridoxal 5’-phosphate (P5P), the bio-active and natural form of vitamin B6.
This is not the first time that the FDA has been petitioned to ban a natural form of B6. In January 2009, the Agency responded to a petition from another drug company, Biostratum, by banning the sale of pyridoxamine—one of three forms of vitamin B6 found in nature—and declaring pyridoxamine a “new drug.” By receiving a favorable ruling from FDA, Biostratum now has a solid monopoly on the sale of pyridoxamine and hopes to gain approval for a drug containing it.
The FDA’s outrageous ruling—a complete ban on the sale of pyridoxamine so that a drug company can convert it into a prescription drug-- threatens the future of other vitamins and natural ingredients.
The currently pending petition filed in November 2007 by Medicure Pharma admits that P5P is a naturally occurring molecule in the vitamin B6 family and thus qualifies as a dietary supplement. Medicure’s point of contention is that P5P in dietary supplements will infringe on profits from a drug the company is currently developing, which includes P5P as an active ingredient!
With surprising candor, Medicure states in it’s 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” [italics ours]. Never mind that natural B-6 has been in the food supply for as long as human beings. According to this reasoning, any drug company has the right to appropriate any part of our diet and make it into the protected property of the drug company. This is outrageous reasoning which the FDA has already, through its Biostratum ruling, bought into.
Medicure also believes, according to the petition, that the FDA’s role is to “balance, on a case-by-case basis if necessary, the competing interests of dietary supplement and pharmaceutical companies.”
Last time we checked, FDA’s mission was to protect and advance the public health. So if P5P already exists in nature, we can’t live without it, and has a multiplicity of positive health effects, for example on carpal tunnel, schizophrenia, and cancer, then how does banning P5P further either of the FDA’s goals?
Medicure makes no consumer safety claims regarding P5P. Medicure simply wants the ban of a natural product in order to secure a monopoly and says so without pretense. Medicure wants to seize control of a vital market and eliminate the availability of P5P to the general public except via their drug!
Once again, your voice needs to be heard. Please contact the FDA, your Senators and Representative to let them know you want to stop what really amounts to the theft of P5P from the public domain. Thank you for taking the time—your involvement really does make a difference.
To view Medicure Pharma’s “citizen’s petition,” click here: http://www.regulations.gov/fdmspublic/Cont...contentType=pdf
To write FDA and your representatives, fill out the form below.
* Your Senators
* Your Representative
* Citizen Petition to Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
PLEASE click on that link and fill out the information to send the emails. If you don't, then - one vitamin at a time - the FDA will continue to wrest away your ability to keep yourSELF healthy! Pete