As you may know, our Colorado medical practice has taken a stand for our patients who disagree with FDA’s classification of the cells in their bodies as prescription drugs in our Regenerative Sciences vs. FDA case. This has led us into a legal battle with that has turned into a potential landmark case. Recently, the court has ordered the agency to identify where congress ever authorized it to classify a drug as anything more than a chemical or chemical metabolite. This move apparently caught the eye of K&L Gates, one of the largest legal firms in the world with more than 2,000 attorneys located on three continents in more than 20 countries. Their Legal Insights newsletter is located at this link. Their conclusion?
“Lastly, the Regenerative case has the potential to affect a fundamental aspect of FDA’s regulatory activities. A key element of the case goes to whether an autologous stem cell procedure is a “drug” under the FDCA. The court has raised questions as to how the “device” definition in the FDCA, which excludes articles that operate by chemical action or that are dependent on being metabolized to achieve their intended purpose, could affect whether a stem cell procedure falls within the “drug” definition. It is unclear whether these questions may lead to stem cells being regulated as “devices” instead of “drugs.” However, if the court were to render such a decision and the ruling were upheld on appeal, it would have far reaching implications for other drug/device determinations in the future.”
“The court’s decision will, to a large degree, dictate the types of legal strategies and business models that will be necessary to successfully perform stem cell procedures in the future.”