EXTRA, EXTRA: US STEM CELL LITIGATION GOES TO THE COURT FOR DECISION
April 4, 2019 Richard Jaffe
http://rickjaffeesq.com/2019/04/04/extra-extra-us-stem-cell-litigation-goes-to-the-court-for-decision/
Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision).
No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject to FDA drug requirements because the law doesn’t apply to them because it’s the practice of medicine and it’s a same day exempt surgicial procedure under 21 CFR. 1271.15.
The papers filed on both sides are excellent. The arguments were clearly made, and professionally and forcefully highlight the differences between the parties’ position.
I don’t think there was any more to be said on behalf of the defendants.
High quality papers like these help the judge make a decision, and I’m sure are appreciated by the court. So, congrats to both sides for a job well-done.
Look to a decision by late April.
Still, I don’t think that a Government win will have the effect the FDA or the anti-private stem cell clinic folks are hoping for. The industry has already, or is in the final process of moving on to the next HCT/P’s, and some of these puppies are likely to be harder for the FDA to stop under the current regulations and guidance documents. And, even if not, the whole process is going to have to start over again, the outcry from the stem cell establishment, inspections, delays, warnings letters, lawsuits. My prediction is that we will be well into the mid-2020’s before we’re at the same point with the next batch of products, at least if the FDA follows its current game plan. That’s going to make some folks happy, and others, not so much.
Rick Jaffe, Esq.
April 4, 2019 Richard Jaffe
http://rickjaffeesq.com/2019/04/04/extra-extra-us-stem-cell-litigation-goes-to-the-court-for-decision/
Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision).
No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject to FDA drug requirements because the law doesn’t apply to them because it’s the practice of medicine and it’s a same day exempt surgicial procedure under 21 CFR. 1271.15.
The papers filed on both sides are excellent. The arguments were clearly made, and professionally and forcefully highlight the differences between the parties’ position.
I don’t think there was any more to be said on behalf of the defendants.
High quality papers like these help the judge make a decision, and I’m sure are appreciated by the court. So, congrats to both sides for a job well-done.
Look to a decision by late April.
Still, I don’t think that a Government win will have the effect the FDA or the anti-private stem cell clinic folks are hoping for. The industry has already, or is in the final process of moving on to the next HCT/P’s, and some of these puppies are likely to be harder for the FDA to stop under the current regulations and guidance documents. And, even if not, the whole process is going to have to start over again, the outcry from the stem cell establishment, inspections, delays, warnings letters, lawsuits. My prediction is that we will be well into the mid-2020’s before we’re at the same point with the next batch of products, at least if the FDA follows its current game plan. That’s going to make some folks happy, and others, not so much.
Rick Jaffe, Esq.