Regulation is not the enemy
With all of today’s uncertainty regarding regulation, many of our clients and colleagues are very concerned. I am not worried about helping clients meet regulations. In the end, all regulatory efforts are about designing a policy, minimizing risk, acting to policy, and monitoring compliance. Nothing about that strikes me as particularly overwhelming. The challenge is really about two things: 1- familiarity with the regulations and 2- the time it takes to get through a certification or accreditation. This is the same whether you are talking about clear or the College of American Pathologists or the FDA. The reason people need consultants is to help with familiarity and to minimize the risk surrounding the time it takes for the process. Many of these regulatory bodies have very long review periods, and almost anything can return the counter to Day 1 and start the clock ticking again. It feels like requiring everyone to get a passport in person, adding a 6 month wait time that resets for any problems, and only keeping one office open per state.
To me, the concern about FDA’s regulation of laboratory developed tests is about their ability to clearly define the standards and the submissions and to have the staff and submission processes to accommodate all the requests that will need to be processed if the law or ruling stands as it is currently written. Given the recent firings of many FDA staff members, I’m not certain those teams have enough people to do the work they were doing before the LDT regulations came into play, and I’m fairly certain they do not have the staff or automation to manage the increased volume that they will need to manage if every lab needs to process LDTs as IVDs. It would be better for these organizations like cap to take the FDA requirements and become accrediting or deemed bodies, able to manage the massive volumes needed.
The actual regulations themselves are not that onerous. I’m always a little surprised when someone says they don’t want to have to track adverse events. That mentality is not good for patient care. I don’t want my family to have samples sent to a place that is unwilling to document those types of things. We document adverse events to prevent them in the future and to understand and identify companies and technologies that are more prone to adverse events. The regulations around labeling seem commonplace to me. Of course, tests should have very tightly described standard operating procedures and general controls. If you are not already subscribed to this philosophy of “follow the procedure as written”, you are also going to have more adverse events.
I think we as an industry should focus on ways to improve the throughput of these regulatory bodies so that innovators do not have to wait for months and years to bring good patient care products to market. I don’t have a problem with meeting guidelines. I have a problem with the way systems are set up to take six months for review. I have a problem with the fact that there aren’t enough people to analyze the data we have. But I don’t have a problem with the regulations themselves or with meeting them. I absolutely want my samples and my health care to be held to standard and you should want that too.
Many of my consulting clients come to me to fulfill the familiarity role for regulation. I like to train people to be comfortable with the rules and compliance, to perform internal audits and to share the tips and tricks to make the process easier. I don’t want to have to share information that basically says “it doesn’t matter if you comply, there a