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.

Rob McCray

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 On July 21, the FDA issued its draft guidance for regulating mobile health, and the agency has been gathering public comment since then about its proposed regulatory scheme.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

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Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.