Cells=Drugs Update-The End of the First Half of our Landmark Case As many of you know, the US FDA believes that our Regenexx-C cultured stem cell procedure is a drug. We disagree for a number of reasons, not the least of which is if the FDA can declare your cells under certain circumstances drugs, then you can no longer have access to that natural resource to save your life or help cure what ails you. For a very in-depth analysis of those issues, see my new book, “The Stem Cells They don’t Want You to Have: How the New Stem Cell Debate will Change Future of Medicine”.
When we began this case, we knew it was a four quarter ball game. The number of complex regulatory, constitutional, and other issues would be unlikely to be decided in the district court. First it took us from 2008-2010 to force the FDA to the field of play, as they refused to take a final position. We stopped performing the cultured procedure in the US the first time FDA took that position because we wanted this case to be about the basis for this regulatory stance and not what any one clinic was or wasn’t doing. So in essence, we viewed this as a football game on the field that would have many “quarters” and a final score, ultimately with referees along the way who would decide the issues. Once we were on the field, the first quarter of play went our way, with the judge quickly placing an order to show cause on the FDA. Other highlights of that first quarter included a Wall Street Journal Op Ed by former FDA commissioner Andrew Von Eschenbach who called out the FDA for casting a pall over the regenerative medicine industry by trying to classify Regenexx-C as a drug. Based on our analysis, we won that quarter. From that point we had to wait a year to see what the score was after the second quarter, which came in early last week. Bottom-line, for reasons that aren’t fully clear to us, the judge in the district court sided with the FDA over Regenexx-C being classified as a drug, while failing to address or answer many of the important regulatory and constitutional questions. In essence, the case is now “punted” to the DC Circuit, where the second half will likely be played. Since most of the main issues have been left unanswered by the district court, these will have to be looked at “de novo” by the DC Circuit.
What does this mean for us right now? Not much. We haven’t preformed Regenexx-C in the US since 2010 and the procedures we perform here have been reviewed and found to be compliant with the same day/same surgery practice of medicine exemption (not FDA regulated). About the only thing that changes is that we’ll be gearing by reformatting legal strategy it for the second half. Who will win this very important ball game over the right to use your body parts as you see fit? I’m sure both sides are confident in their predictions. In the meantime, we’ll just move the ball down the field and see who’s ahead when the final whistle blows.