By Chris Wolski
If you want to get an American riled up—slip the word “regulation” somewhere in a sentence. Fireworks will likely ensue. In CLP‘s July cover story, we’re examining how the proposed VALID Act regulations will affect the laboratory industry and society as a whole.
Before I level my own opinions on the issue, I want to make it clear that I’m not against regulations, and I don’t think many of the readers of this column, no matter what side of the VALID issue they come down on, are either. Regulations are just rules. We all live by them in some way every day—whether they’re personal (brush your teeth before bed), part of our collective social contract (hold the door for the person behind you), professional (calibrate an instrument prior to using) or legal (wear your seatbelt while driving)—we are governed by rules in endless ways every hour of our lives.
The best regulations are designed to make life more orderly, safer, easier—a society without regulations is a society beset by chaos and grief. But if these regulations get in the way of living, then we have a right, and I’d say a duty, to be against them.
The VALID Act regulations—which at the time of this writing are winding their way through committee—definitely fall into the latter camp.
The way labs quickly pivoted and created dozens maybe even hundreds of COVID-19 tests of all types in a matter of a few weeks and months at the beginning of pandemic should be the argument for maintaining the status quo system of laboratory-developed tests (LDTs) that have fueled innovation for decades. Certainly, there should be regulations—and we have many governing LDTs already. Have there been instances when the rules didn’t work? Of course, but on balance they have offered the framework that both protects patients and fosters innovation.
Here’s a hard fact we have to accept: Regulations are never perfect. They will be broken. That’s what enforcement agencies are for—perhaps a better solution is upping enforcement and the penalties for breaking the rules, instead of penalizing everyone.
Simply put, more regulations on LDTs will stifle the best and the brightest (look what’s happening in the EU already). And that will hurt patients and society as a whole.
If you oppose VALID Act regulations, now is the time to act. Contact your national representatives and respond to the clarion calls of the industry to step up and meet this challenge. The current LDT system works—don’t let it go without a fight.
Chris Wolski is chief editor of CLP.