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Burgess hopes to block FDA from regulating genetic tests
Letting the Food and Drug Administration regulate genetic tests would cripple innovation in a field with tremendous promise for patients and U.S. competitiveness, Rep. Michael Burgess (R-Texas) said Thursday.
The FDA has said it intends to regulate genetic tests that are developed in laboratories. Burgess, who is a doctor, has introduced a bill to block the FDA’s effort. The drug and device industries complain about long approval delays at the FDA, and Burgess said he’s afraid genetic tests would be “subsumed” by that bureaucracy.
“We need a regulatory framework that is sensitive to the fact that this is an evolving science,” Burgess said Wednesday at a policy forum sponsored by The Hill and the American Clinical Laboratory Association.
Genetic tests have the potential to identify risk factors even before a patient gets sick and to help tailor treatments to each patient’s unique needs. The technology, however, is still relatively new.
“We do lead the world, and this is a resource we can ill afford to lose or regulate out of existence,” Burgess said.
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.
