Utah, who may have the strongest supliments industry in the United Sates, will soon be hit by a new FDA ruling.
In 2005 Triangle Business Journal wrote BioStratum was in trouble because they were using Pyridorin (pyridoxamine dihydrochloride) to develop prescription drugs. Pyridoxamine is a natural component of vitamin B6 so BioStratum was unable to patent it.
Friday, October 14, 2005
DURHAM – After pumping about $100 million over 11 years into a biotech company developing a promising treatment for diabetic kidney disease, investors in BioStratum discovered the drug’s only active ingredient is sold on the Internet to anybody with a credit card.
The lack of intellectual property protection surrounding BioStratum’s drug Pyridorin is scaring away many potential partners from funding the drug’s third phase of clinical trials – typically the final tests before a drug is approved and sold commercially.
Having spent millions developing Pyridorin and other drugs in its pipeline, BioStratum does not have the capital to take the drug any further. The cash crunch has prompted investors to order a restructuring.
As stated later on in this article, BioStratum’s solution was to petition the FDA to declare pyridoxamine (a form of vitamin B6) a pharmaceutical drug, limiting access to the substance.
Intellectual property law does not allow BioStratum to own patents on pyridoxamine, but the company has a pending patent application on its method of obtaining pyridoxamine from vitamin B6.
Steiner says BioStratum officials wrote individually to companies that were selling the supplements, asking that they halt sales. The targeted companies agreed, Steiner says.
Fearful that other competitors would pop up in the future, BioStratum filed a “citizen petition” in July [2005] with the FDA seeking to disallow such sales. It claimed:
- Pyridoxamine was not sold as a drug supplement prior to the enactment of the Dietary Supplement Health and Education Act of 1994 and hence was not “grandfathered” in as a dietary supplement.
- Internet sales began after July 1999 when BioStratum submitted an “investigational new drug” filing for Pyridorin, and once a substance is part of a clinical trial it cannot be sold as a nutritional supplement, the company believes. “In our mind this is very clear,” says Steiner. “Before clinical trials, this substance was not sold … (so) in the U.S. it is illegal.”
The Triangle Business Journal claims pyridoxamine is derived from vitamin B6, where Wikipedia claims pyridoxamine is a component of vitamin B6, so some further investigation is warranted.
The Council on Responsible Nutrition submitted this fact sheet to the FDA stating:
Vitamin B6 is a water-soluble vitamin that exists in three major chemical forms: pyridoxine, pyridoxal, and pyridoxamine.
You can see all information submitted to the FDA on pyridoxamine at their web site. Notice the the FDA started calling pyridoxamine a drug before even determining whether or not it was a drug for BioStratum. The title of this docket is “2005P-0305: Remove Dietary Supplements that Contain the Drug Pyridoxamine“
http://www.fda.gov/ohrms/dockets/dockets/05p0305/05p0305.htm
At any rate, BioStratum has won this battle. They couldn’t get a patent on a substance occurring in nature, so they have managed to get the FDA to prevent companies from using it.
The whistle was blown on the FDA by The American Association of Health Freedom in an article titled When is a Vitamin Not a Vitamin? When the FDA Says So!. You can sign up for alerts from American Association of Health Freedom so you can be alerted to similar issues.
Another publication who alerted people to this issue was Natural News on February 12, 2009, although for some strange reason they did not identify BioStratum as the culprit: FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements
If you would like to contact your representatives and ask them to pass laws baning the FDA from declaring natural supplements drugs, you can find their contact information at Congress.org.
Perhaps the FDA’s cozy relationship with drug companies is one reason why Congressman Ron Paul wants to eliminate the FDA.
I don’t expect to see many news reports on this issue by the mainstream media, but I hope to be proven wrong. When you watch TV who pays for more ads than anyone else? How often do you sit through a commercial break where you don’t see at least one drug company ad?
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