Pharmaceutical companies could keep you from buying vitamin B6 in your store
Check out the story of Medicure’s MC-1 & Pyridoxal 5’-Phosphate (P5P).
Vitamin B6 is naturally found in humans. But in 2007, another fledgling drug-development company, Medicure, filed a citizen’s petition with the FDA claiming that pyridoxal 5’-phophate (P5P) was an unapproved new drug being sold illegally as a dietary supplement. The filing was undoubtedly motivated by the rulings from Pharmanex and Biostratum. As mentioned in my previous blog, P5P is considered the active form of vitamin B6. It is also found in some animal-source proteins. Other dietary forms of vitamin B6 (pyridoxine, pyridoxamine & pyridoxal) are converted to P5P in the body.
Medicure has an IND on file with the FDA dating back to 2001 and is currently studying P5P (a.k.a. MC-1, Avastrem, Tardoxal) in Phase II trials for the treatment of tardive dyskinesia, in patients with schizophrenia, and in a separate program for lipid lowering/metabolic syndrome. Medicure refers to P5P as a vitamin B6 metabolite. In 2005, the FDA granted MC-1 (P5P) fast-track status for its potential to reduce cardiovascular events associated with ischemia resulting from angioplasty, heart bypass surgery, and acute coronary syndrome, but as of May 2009 investigations for these acute cardiovascular indications have been placed on hold by Medicure. Nevertheless, Medicure believes that their research with P5P in this area created the insight for their two ongoing MC-1 development programs. Medicure contends that:
1) Pyridoxal 5’-phophate (P5P) was not marketed as a dietary supplement prior to DSHEA
2) Nobody has ever filed an NDI notification for P5P
3) Therefore, P5P was an unapproved new drug being marketed illegally as a dietary supplement
That rationale should sound familiar. It is essentially the same contention made by Biostratum for pyridoxamine. And even though the FDA has yet to rule on this petition, P5P’s continued life as a dietary supplement does not look good. Why?
Despite Medicure recognizing that P5P was, in fact, marketed as a dietary supplement (as early as 1996) prior to their filing an IND, it claims that there is no evidence of P5P being marketed prior to DSHEA. In addition, an NDI notification for P5P has never been filed with the FDA. Under the precedent set in the Biostratum opinion, viz. it doesn’t matter if an article was marketed as a dietary supplement prior to drug investigations (or IND filing) if it wasn’t legallymarketed (no NDI filed). Based on this precedent, a favorable ruling for Medicure’s petition is likely.
However the fact that there exists certifiable evidence that P5P was marketed prior to Medicure’s IND filing, albeit “illegally,” could in theory present a small chance the petition could be denied. To do this the FDA would have to reverse the precedent it set in Biostratum. Why might the FDA do this?
The FDA could choose to recognize that specifics about the NDI submission process were never clearly defined after the passage of DSHEA, leading to confusion in the dietary-supplement industry about what was grandfathered and what necessitated an NDI filing. However, this is unlikely. More plausible is that the FDA will rule in favor of Medicure, thus further bulwarking their incentive to carry out research. P5P will be another form of vitamin B6 that will disappear from supplement shelves.
Case Open: However, P5P is likely to be ruled a drug, not a supplement. Reward most likely goes to pharmaceutical company.
In HealthThink on WellWise.org, I ruminate on all thoughts health especially as they intersect with dietary supplements. How do we really think about health [when we’re healthy]? And what does our behavior belie about how we think about health? Aside from the general rule that applies to the entire blogosphere – never believe what you read in a blog – here are two tenets for this blog: 1) spending your good time reading entitles you to comment/complain about HealthThink and 2) if you complain/comment do not be surprised to see your ideas or words appear in said blog. If you complain/comment using words in the spirit of this wordsmithing hit, you’ll get extra credit. A blog with rules and extra credit: fantastic.