Six Members of Congress recently requested (see letter to the right) a status update from the FDA and FCC regarding the agencies’ Memorandum of Understanding and public meeting in July 2010, declaring their interest in encouraging wireless health (see WLSA comments here). The Members demands are logical. This is a matter of the highest importance. It is unfortunate that the group is not bipartisan. We need to conduct a societal discussion of our expectations of these agencies (especially the FDA) and specifically how to balance competing demands for patient safety with the societal need for innovative solutions to unmet population healthcare needs.
The FDA is currently considering public comments on its Draft Guidance on Mobile Medical Applications (see WLSA comments here) and is considering guidance on Clinical Decision Support software. In all of these activities, the agency is caught between conflicting expectations that it protect public health by limiting the marketing and use of potentially dangerous products while at the same time it advances public health through useful innovation. Innovation and change necessarily involves risk. My perspective is that even rudimentary wireless health innovation can deliver benefits to people who today have no effective access to healthcare assistance in many situations. The risk calculation should be take into account the inadequacy of the status quo.
The FDA knows from experience that it will be pilloried in the press and in politics if it approves products that are involved in harm to patients or consumers. It is human nature to be more cautious after being called on the carpet a few times. This is analogous to the lending industry post-Great Recession. Bankers know that a loan not made is a loan that cannot enter default, so economic development has been stifled because even credit worthy companies and entrepreneurs cannot access the capital they need to create and grow their businesses. In healthcare, society has an interest in ensuring that promising wireless health solutions are brought into service, monitored and improved as rapidly as possible.
The stakeholders of the United States need to conduct a conversation about health, healthcare, innovation, risk and responsibility that is society-wide and nonpartisan. These matters will not be resolved by the 2012 election. They will not be resolved solely by the actions of business, science, government or charities.
I am pleased that Congress is watching. For our next step, WLSA is working to bring together a community of engaged organizations and thought leaders to initiate this most important conversation. It will not be completed by Twitter posts. Please join us and share your thoughts.
Robert B. McCray
President & CEO
Wireless-Life Sciences Alliance