James Boiani Quoted in “FDA Wants to Ease Diagnostic/Drug Combo Study Paperwork”

Bloomberg BNA Medical Devices & Industry Report

James A. Boiani, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA Medical Devices & Industry Report, in “FDA Wants to Ease Diagnostic/Drug Combo Study Paperwork,” by Randy Kubetin. (Read the full version – subscription required.)

Following is an excerpt:

Companies developing products that combine a diagnostic test and a cancer drug would face less paperwork to get their clinical trials going under an FDA policy proposal.

The agency said it wants to streamline the process for submitting information needed to gauge the risk of using an investigational in vitro diagnostic in a clinical trial for an oncology drug. An FDA draft guidance document released April 13 would allow sponsors to include risk information on the diagnostic and the drug in their investigational new drug application (IND). Current agency policy requires sponsors to submit a separate investigational device exemption (IDE) on the diagnostic for the risk determination.

The guidance could give a boost to the burgeoning field of precision medicine, where diagnostic tests are used to determine what drugs or therapies are likely to work best in specific patients based on their genetic makeup and other personal factors. The streamlined process would let sponsors make fewer submissions in some cases and could allow studies to start sooner, the FDA said.

James A. Boiani, an attorney with Epstein Becker & Green in Washington, said the guidance could help speed co-development of drugs and companion or complementary diagnostics. “It’s providing an optional pathway to create more review efficiency, which makes good sense,” he told Bloomberg Law April 13.

The FDA’s Center for Devices and Radiological Health, which oversees diagnostics and devices, is trying to develop a more flexible diagnostics framework, Boiani said. The center recognizes that it needs to keep up with advancing technologies like next-generation DNA sequencing and associated clinical testing, he said.