James Boiani Quoted in “Device Lawyer: FDA Guidances Provide Clarity on Payer Communication”

FDA Week

James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “Device Lawyer: FDA Guidances Provide Clarity on Payer Communication,” by David Roza. (Read the full version – subscription required.)

Following is an excerpt:

A device industry lawyer applauded the release of two FDA guidances that he said provide long-awaited clarity for device manufacturers on how they can communicate health care economic information (HCEI) and certain off-label information about FDA-approved or cleared devices to payers. The guidance, the lawyer says, serves to define FDA-approved ways for sharing such information, which could encourage more companies to communicate that information with payers.

James Boiani, a member of Epstein Becker & Green’s Health Care and Life Sciences practice, said his clients have been waiting for these guidances since enactment of the Food and Drug Administration Modernization Act (FDAMA) of 1997. FDAMA section 114 allows manufactures to disseminate information about off-label uses of drugs and medical devices and lets drug companies provide economic information about their products to formulary committees, managed care organizations and large-scale buyers of health care products.

“Just the fact that they released [the guidances] is helpful, this is an issue a lot of my clients have struggled with since the provision was put into law,” Boiani said. “It’s been out there for a long time and this is certainly the most comprehensive guidance we’ve had.” …

The lawyer said the main takeaway from the guidance is that device makers must be “exceedingly clear” about which uses for a device are on label and which are not when communicating with payers. Providing an FDA roadmap on the matter could help more companies communicate with payers more regularly, he said.

“I think in a sense it gives them an accepted pathway for communicating that information,” Boiani said. “Some device makers communicate information more aggressively than others, and this provides FDA’s thinking and levels the playing field.”