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 Asserts Regulatory Authority Over Laboratory Developed Tests."
Following is an excerpt:
The Food and Drug Administration July 31 expanded its commitment to personalized medicine by issuing its final guidance on companion diagnostics and notifying Congress of its plan for more FDA oversight of laboratory developed tests (LDTs).
The final guidance on the development, review and approval or clearance of in vitro companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug, has been long anticipated, and the regulation of LDTs has long been a matter of controversy.
Attorney Bradley Merrill Thompson, of Epstein Becker & Green PC in Washington, said that the guidance, which he called "impressive and thorough," is a good start, but that involvement from stakeholders is essential.
"FDA obviously spent quite a bit of time thinking through these issues, and appears committed to taking a risk-based approach, not just on the risk associated with the clinical use of a test and the resources required, but also more broadly on such public health concerns as unmet medical need and rare conditions," Thompson said.
Thompson also noted evidence of the FDA's flexibility in trying to help the labs avoid undue burden and indicated that the agency has to be prepared to offer the same accommodations to other manufacturers of lab tests.
