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« High Court Denies Apotex Petition on 180-Day Exclusivity | Main | NJ District Court Declines to Exercise Declaratory Judgment Jurisdiction in Feud Over Generic ANTARA; Lupin is Given Another Bite at the Apple »

January 19, 2011


Chris Centeno, M.D.

This is Doctor Centeno. One of our physicians alerted me to these blog posts which concern our clinic, so I thought it appropriate to reply. At the end of the day, we sued FDA four times to get them to sue us. Basically, FDA claimed it had authority to tell a physician how to practice medicine and we challenged that authority. During our challenges, FDA claimed that it hadn't made up its mind (for two years) about how it would decide to act in considering our culturing of a patient's own stem cells the same as a new drug. This created a legal conundrum called "ripeness". As an example of the doctrine of ripeness, if the government shows up tomorrow and wants to blow up your house, you generally can't question it's authority to blow up your house until after your house is blown up-meaning until the government takes some action you can't question whether they have the authority to take the action. Hence, we had to poke the tiger 4 times to get the tiger to come out of its cage and "take an action". We're now thankfully in a situation where we can challenge the government’s authority to control the practice of medicine, something congress and the courts have repeatedly barred the FDA from doing.

This is a very big and seminal case. At its heart is whether the stem cells in your body are drugs to be federally regulated or body parts to use as you and your doctor see fit. These two outcomes have huge societal impacts. If they are drugs, then expect an expensive and slow adoption of adult stem cells as therapy. Some diseases will never be treated with cells because the cost of FDA approval (about 500 M USD) won't support the disease market and the cost of cells being used "off-label" will be astronomical because of the 500 M USD approval cost per disease. We believe there will be adverse societal impacts to this slow adoption that will show up as an increase morbidity and mortality (for a scientific discussion of how this is measured, see FDAReview.org, a project of The Independent Institute ). If the stem cells in your body are in fact body parts and physicians are free to practice using those body parts with responsible medicine, then there will be a rapid adoption of these new tools.

In summary, this is a very big and important case and appreciate you following it.

Chris Centeno, M.D.

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