Recently, Bradley Merril Thompson, a representative of the mHealth Regulatory Coalition (MRC), wrote a letter to Health and Human Services Secretary Kathleen Sebelius, asking the FDA to issue final guidance over mobile health application regulation, “as soon as reasonably possible.”
While it’s tempting to make a snarky remark about the government’s versus the private sector’s definition of “as soon as reasonably possible,” I’ll refrain and state simply that the FDA’s glacial response on this one may have led to slowing of development and investment in mobile health.
Interestingly, Mr. Thompson adds, “Some people mistakenly believe that the final guidance will expand FDA jurisdiction. It will not.”
I’m not so certain. I think the level of direct FDA involvement and regulation will come about largely in reaction to how the industry at large interprets and acts upon the guidelines. That’s as it should be. Let the marketplace determine the viability of mobile health products, with a prudent approach that acknowledges the FDA’s responsibility to safeguard public health. I fully expect that, after the guidelines are released, there will be a formative period where entrepreneurs and the government will work – as partners and sometimes as adversaries – to better define what’s best for the market and for consumers.
I believe that’s the attitude that should be guiding the industry today, while it waits (and waits) for FDA guidance. No business venture is without risk, but the companies that are willing to advance now, confident that their products are safe and effective, are much more likely to prosper and establish market presence than those who continue to wait.