Burgess acknowledged that his bill to stop the FDA from regulating lab-developed tests hasn’t gotten much attention. He said he wants to move it through the regular legislative process, rather than attach it to a separate bill.
Rep. Charles Gonzalez (D-Texas) told an emotional story about a cancer patient who used genetic testing to figure out whether her daughters were also at risk for cancer, saying he agreed fully with the need for further innovation. But also said generally that he and other Democrats might have problems with Burgess’s proposal.
His bill would explicitly state that the FDA doesn’t have the legal power to regulate genetic tests — authority Burgess said he was “concerned” to see the agency exerting without a clear sign-off from Congress.
Marc Grodman, chief executive of Bio-Reference Laboratories, said FDA regulation would unnecessarily stand in the way of important advances.
“Freezing technology, freezing innovation in an industry that is already regulated only has an effect to increase cost,” Grodman said.
The tests are currently regulated under the Centers for Medicare and Medicaid Services (CMS). Moving oversight from CMS to the FDA would make it harder to get the most out of genetic testing, Grodman said.
Genetic tests are often used as a diagnostic tool. And drug companies are developing new, more narrowly targeted products to go hand in hand with the tests. But Grodman said FDA regulation could raise the risk that test developers would have to seek a new approval along with every new drug that puts a slight twist on fundamentally the same test.
“We need the ability to innovate; we need the ability to provide data,” he said.