If the goal of last week's meeting on FDA's regulation of LDTs (co-sponsored by ACLA and AMP) was to continue the dialog with the agency and start to move towards consensus, then it was slightly off the mark. As in, "you were aiming for Mars but ended up on Saturn" off the mark. If, on the other hand, the goal was to keep hitting on the same talking points until you can make a drinking game out of it, then mission accomplished!
"FDA's stifling innovation!" (drink)
"We care about patient safety!" (drink)
"What’s the value-add of FDA regulation?" (drink)
Good thing we weren't actually drinking during the meeting, or we'd have been tanked by the first break. Frankly, if you're going to make people get on a plane the week of Thanksgiving, the least you can do is have some new ideas. Since AMP and ACLA seem to be at a loss at this point for how to progress, here are some suggestions of how to move forward with the process:
- Wishing doesn't make it so
There still seems to be this idea that if you keep talking about it and hitting the same talking points, this whole FDA regulation thing will go away. That may have worked in the past, but FDA has renewed energy on this issue, and is using much stronger language than it did with IVDMIA. They are clearly concerned about the risks posed by LDTs. Enforcement discretion is ending. So let's start with accepting the new reality, then get to work shaping it. Which leads to… - Collaboration good, confrontation bad
Having panel discussions that are led by obviously biased "moderators" is counterproductive at best, and at worst looks petty and unprofessional. The cable news models of debate are entertaining, but don't really provide any useful outputs. Future discussions should be balanced with individuals from all sides of the issue, led by moderators that are dedicated to building consensus (follow Paul Radensky's lead). Organizers should reach out to people who are interested in finding real solutions. - Do your homework
It was pretty clear at the meeting that very few present had taken more than a cursory look at the FDA regulations, particularly the QSR. Take time to learn the regulations and map your processes against the QSR. This is where organizations like AMP and ACLA could really add value for their members by helping them understand the true scope of work. We've helped implement quality systems in several small companies (<20 employees), and while the impact is not trivial, it's not as significant as some are claiming. - Get your test(s) under control
Although they may not have intended to, many lab directors' comments served to reinforce why FDA is concerned about LDTs. When you admit that you don't know how RUO manufacturers make the products you use in your clinical tests, you've just jumped up the risk scale. Anyone that has audited RUO-wannabe-IVD manufacturers will tell you that there is a gradient of quality going from ISO/GMP compliant to "I built it once in my garage, what's the big deal?" Unless you audit your suppliers, you can't understand the risk their product poses. FDA has gone after RUO manufacturers in the past for selling to clinical labs because they do know the risk. The labs need to recognize the risk as well and develop a better understanding of the products they use. - Let the physician determine the claims
Courtney Harper (FDA) used vitamin D testing as nice example of the difference between clinical validity and clinical utility at the meeting. There are cleared tests that accurately and reproducibility report vitamin D levels, which physicians can in turn use in the treatment of diseases like depression. Off-label use of tests by physicians is within the law. For more research-focused applications, it is a less risky approach for the labs than making claims they haven't fully validated. - Everyone cares about patient safety
This is quickly becoming a bad joke. Everyone in this industry is first and foremost concerned with patient safety. IVD manufacturers are. Clinical lab directors are. FDA is. CMS is. FDA's concern with patient safety is due largely to the fact that they have seen things in the device industry that make them worry. Bad suppliers. Poor clinical data. Lousy software. And while most clinical labs care deeply about quality, experience tells FDA that there will be others that won't quite make the cut.
Hopefully everyone got it out of their system at last month's meeting. The time has come for all sides to stop talking past one another and move towards agreement. FDA has repeatedly shown a willingness to do this, and was again asking for proposals from industry at the meeting. The clinical lab community needs to respond with meaningful proposals, or run the risk of having an increasingly frustrated FDA impose a solution on them.
