Bradley Merrill Thompson Quoted in “FDA Seeks to Regulate Lab-Developed Tests”

The Wall Street Journal

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 "FDA Seeks to Regulate Lab-Developed Tests."

Following is an excerpt:

The Food and Drug Administration on Thursday laid out a proposed new regulatory plan to oversee potentially thousands of laboratory-developed medical tests that the agency contends can be prone to errors.

These diagnostic and other tests are for diseases including cancer, heart disease and bacterial infections. They can also assess how well a given drug will help patients with a certain genetic makeup. For years, the FDA allowed these medical tests to be used as niche products at hospitals and labs largely without agency approval or scrutiny.

Bradley Merrill Thompson, who works at the firm Epstein Becker Green in Washington and represents companion-diagnostic companies, called the document "impressive and thorough." He said the agency is focusing "not just on the risk" with tests, "but also more broadly on such public health concerns as unmet medical need and rare conditions."