In response to a number of high profile news stories involving stem cell procedures gone wrong, the FDA issued a set of new guidelines and policies in November (2017) intended to let the emerging regenerative medicine industry know that the government would begin taking steps to increase regulatory oversight. This is by no means the first time the FDA has gotten involved. In 2005, the federal agency implemented a regulatory framework that actually opened the door to regenerative medicine.
If there’s anything negative to be said about the most recent FDA action it is the fact that it has created some confusion. For example, previous regulatory policy allowed for the practice of autologous PRP and stem cell therapies without direct FDA approval as long as blood and stem cells extracted from patients was not altered in such a way as to classify the material as a drug.
One of the new policies issued in November creates a bit of ambiguity by suggesting that material processed in a centrifuge could be classified as a drug. If that’s true – if centrifuged blood and stem cells are really drugs – then all the current regenerative medicine procedures in use for musculoskeletal treatments would have to undergo years of FDA scrutiny before being approved.
In their defense, the FDA has said in the weeks following the release of the new policies that they are working to help clear the air. FDA Commissioner Scott Gottlieb has gone so far as to encourage regenerative medicine providers to speak with his agency to get direct answers to their regulatory questions.
The Future of Regenerative Medicine
Whether or not the FDA gets heavily involved in regulating regenerative medicine remains to be seen. In any case, the future of regenerative medicine looks bright at this point. Countless studies are now underway, investigating the possibility of using regenerative medicine treatments to address just about every injury and illness under the sun. It is hard to imagine the FDA coming down on the industry so hard as to stifle research and innovation.
That said, the FDA is making at least some attempt to encourage regenerative medicine innovation. For example, a new approval process allows multiple researchers and research groups to pool their data in order to provide enough information for the FDA to make a decision. Gottlieb says that as long as researchers are “following a common manufacturing protocol, they can band together and pool their data and submit one common application.” If that application were approved, all the parties involved would get individual FDA approval.
Gottlieb has also said that his agency intends to facilitate better communication between regulators and those companies and educational institutions working to move regenerative medicine forward. The goal of better communication is to create a dialogue that allows the FDA to develop a regulatory framework that encourages further research without stifling innovation.
It would no doubt be nothing short of a miracle if the FDA were able to institute such a regulatory framework. Unfortunately, the agency does not have history on its side. When government begins to regulate, the tendency is often to go too far. Regulations often do more harm than good in terms of innovation. Hopefully that will not be the case here.
At Apex Biologix in Utah, doctors learn how to use regenerative medicine procedures to help patient’s live better lives. It would be a real shame if the FDA’s new regulatory policies hinder what doctors are able to offer by way of PRP and stem cell therapies. Let’s hope it doesn’t come to that.