On October 3, FDA’s Center for Devices and Radiological Health (CDRH) issued a press release entitled “FDA outlines plans for an outside network of scientific experts“. The release states that the purpose of the effort is to “plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology…”
Emerging technology has played a large part in healthcare over the past five years, but it is not limited to scientific advances. Five years ago, even with the Internet, communications was pretty much a one-way street. You, the communicator, packaged a message and sent it out to me, the audience via newspapers or broadcast media. You put an ad out on awareness needs for a certain disease – a message aimed at getting some members of the public more at risk than others to take a medical test. You put the ad on the side of a bus and sent it around town for millions to see, hoping to motivate a few.
Today, the art of communications is defined in an entirely different way. The balance of power, if you will, has shifted from you, the communicator, to me – the audience. Today I don’t pick up news when it is broadcast to me, I pick it up when and where I feel like it, from sources that I trust. And most important of all, as I pass it along, I comment on it – so that the communicator now has to share the power of their message with the audience. Five years ago, communicators held the cards, today the audience has picked up some aces. As the Pew Internet & American Life Project has pointed out, the hallmarks of today’s communications are that it must be portable – increasingly so with mobile, personalized – it must be news from sources the audience trusts, and it must be participatory – the audience gets to generate the news and/or provide commentary on it.
In its October 3 release, CDRH stated that the motive for the move to seek outside help was based on the fact that “traditional sources of external expertise, such as public workshops, conferences and literature may lag behind current research”. Remembering that Facebook, YouTube and Twitter all became mainstays in today’s communications environment – changing the very foundation of communications – within the past few short years, that statement could have easily been referring not to advances in medical devices but to communications.
An outside panel of communications experts could advise the agency on the impact of changes in communications in the healthcare environment. Like the CDRH group, it does not have to provide policy solutions or opinions, though it perhaps should, it would be a sharing of expertise to help FDA staff develop their own conclusions.
Communications does not happen in a vacuum. There are public health consequences. That is why FDA regulates healthcare communications. Lacking the ability to keep up with changes likewise can have public health implications.
The extremely long track record of FDA in attempting to figure out the Internet (first public meeting held in October 1996) and social media (first public meeting held in November, 2009) has yielded no guidance, with little transparency into the process. It is time for FDA to emulate the example of CDRH and seek outside communications expertise to help the agency better formulate policy on a timely basis.