Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “ACLA Rebukes Idea of Congress Handling Confusion Over LDTs as it Did HIT.”
Following is an excerpt:
Now that FDA has sent Congress a preliminary regulatory framework for laboratory-developed, the Combination Products Coalition is urging lawmakers to address possible redundancies between FDA and CMS regulation by mandating federal agencies meet with stakeholders to develop a proposed regulatory framework — similar to what Congress did with health IT regulation.
CPC counsel Bradley Merrill Thompson said the confusion over LDT regulation seemed similar to health IT and suggested lawmakers address the issue in a similar manner. Under the FDA Safety and Innovation Act, Congress mandated FDA, Office of the National Coordinator for Health IT and Federal Communications Commission develop a unified HIT regulatory framework informed by stakeholders within a federal working group.
Congress should direct FDA, CMS and any other federal agencies involved to work with stakeholders to propose a risk-based, regulatory framework for LDTs, Thompson said. If lawmakers take a similar route with LDT regulation as they did with HIT it will ensure a transparent process where the agencies will not unilaterally make decisions, he added.
“This is very complicated, and requires weighing the need for innovation in new diagnostic test development and timely access to new technologies on the one hand, with the assurance of safety and effectiveness on the other,” Thompson said. “Accomplishing that will require much good-faith discussion among many stakeholders.”
Thompson further said Congress could improve upon the previous mandate by imposing a firmer timeline. The agencies were slow to act on the mandate in the months immediately following FDASIA’s enactment and if lawmakers could figure out a way to accelerate the agencies’ actions that would be useful, he said.