Continuing their discussion on laboratory-developed tests (LDTs), Scott Gottlieb, MD, asked Kavita Patel, MD, MS, and Ted Okon, MBA, about the politics behind the FDA’s decision to regulate the LDTs, and when they think the FDA will finish formalizing these regulations.
Dr Gottlieb mentioned that the FDA has been contemplating the regulations of LDTs for almost 15 years, and originally the agency said it would work only on those tests that fell out of the Clinical Laboratory Improvement Amendments (CLIA) Act framework, the ones with more complexity and that were harder to prove in terms of clinical validity. The FDA has now changed its approach and wants to regulate the entire field on a kind of risk-based scheme.
Dr Patel offered a variety of reasons for the FDA’s new approach, the first being problems regarding validity and utility. Another aspect to consider is that the country is nearing the end of an administration, and what the FDA pushes will have repercussions even in a different political administration. “If the FDA starts this process, which they have, they’ll have to see it through to some degree. That’s just how bureaucracies work,” she stated.
Okon added that the media attention has also prompted the FDA’s response, with the FDA having recently gone up before the House hearing on the Energy and Commerce committee, giving about 20 stories over the past 10 years as evidence.
“It’s going to be interesting to see what happens, but again, I don’t think the solution is going to be on the regulatory side, the government side,” said Okon. “I think this is something that is going to take a consortium of payers, even providers, getting together and really doing something neat, in addition to CLIA modernizing and basically coming up to speed.”
Dr Gottlieb then asked if the FDA could move forward with the guidance it had received near the end of the Bush administration and get these regulations out within the next year.
Dr Patel remained optimistic, saying that the FDA could get it done, but the process would be hard. “There are so many things this administration wants to get out in the last mile so I would still say it’s a 50/50 shot.”
Okon opined that with 2016 being an election year, the politics are tough, and because of what else is going on in the world, he believed it less likely to happen.