FDA at the Center of Huge Gray Area in Establishing Regs for Wireless Health, Execs Say
When Rob McCray founded San Diego’s Wireless Life Sciences Alliance (WLSA) in 2005, the group’s corporate membership constituted just three companies: Qualcomm; Johnson & Johnson; and TripleTree, a boutique banking and research firm where McCray was a partner.
Since then, the convergence of healthcare and wireless technologies has become more obvious, and the WLSA has expanded to 65 dues-paying members, including life sciences companies like Sanofi, health services providers like OptumHealth, and consumer products companies like Procter & Gamble. Under McCray, who is now CEO, the WLSA also has evolved from a volunteer group into a more professional organization that recently hired Molly Cogan as executive director, with responsibility for overseeing conferences and other events.
“We’re structured as a nonprofit trade association, but our mission really is to create better access to affordable healthcare,” McCray says. Combining the power of wireless devices, smartphones, and tablets with medical care represents a technology revolution that’s potentially as powerful as the Internet itself, but as McCray adds, “you have to come up with products, services, and apps that are effective and safe.”
And therein lies the rub.
As the FDA asserted its regulatory authority over wireless health, a wave of innovation now underway has come under a cloud of uncertainty. On July 21, the FDA issued its draft guidance for regulating mobile health, and the agency has been gathering public comment since then about its proposed regulatory scheme. That process is scheduled to continue until Oct. 19, and it will likely take the agency a year after that to finalize its draft guidelines and issue formal regulations, according to Russell Fox, who tracks such regulatory issues in Washington D.C. for the Mintz Levin law firm.
“What the FDA is going to do in wireless health and mobile is the top factor in what investors are going to do,” McCray says. “The FDA is the first topic to come to mind for them.”
McCray says he views wireless health as a wave of healthcare-related technologies that is building at a time of huge growth driven by the aging of the baby boom generation. When medicine usually adopts new technology, the effect has been to increase the cost of … Next Page »