Steve, excellent post. I wonder if the IVD manufacturers, especially the big ones like Abbott or BD would really give up and let labs take over their growing market share. This could certainly deter smaller startups wanting to get to market quickly. It will certainly slow down innovation, as you correctly point out, that labs could do this quickly and more cheaply compared to IVD manufacturers.
On a second note, do you think there might be more challenges to FDA's authority related to medical devices, just because someone doesn't like the way the agency exercises their regulatory authority. I am thinking of Chevron doctrine as that one also has been thrown out of the window!
Naveen, realistically, I don't think that this single decision will drive large commercial IVD manufacturers out of the market. But as you note, it's a disincentive to new-market entrants and we could see shrinking of commercial activity.
With the death of Chevron, I absolutely expect more challenges to FDA authority and regulatory interpretation. All bets are Not off, meaning that when the agency's position is well-supported and non-controversial, courts likely will uphold FDA's view. But there definitely will be outlier cases where courts substitute their own views for FDA's.
Steve, excellent post. I wonder if the IVD manufacturers, especially the big ones like Abbott or BD would really give up and let labs take over their growing market share. This could certainly deter smaller startups wanting to get to market quickly. It will certainly slow down innovation, as you correctly point out, that labs could do this quickly and more cheaply compared to IVD manufacturers.
On a second note, do you think there might be more challenges to FDA's authority related to medical devices, just because someone doesn't like the way the agency exercises their regulatory authority. I am thinking of Chevron doctrine as that one also has been thrown out of the window!
Naveen, realistically, I don't think that this single decision will drive large commercial IVD manufacturers out of the market. But as you note, it's a disincentive to new-market entrants and we could see shrinking of commercial activity.
With the death of Chevron, I absolutely expect more challenges to FDA authority and regulatory interpretation. All bets are Not off, meaning that when the agency's position is well-supported and non-controversial, courts likely will uphold FDA's view. But there definitely will be outlier cases where courts substitute their own views for FDA's.
Thanks Steve! I worry that FDA may no longer have the staff to defend the agency in courts!