FDA: On Message, But Off Track?

That’s no problem. I can check that box. It’s kind of a blessing and a curse, actually. For the most part, the political theater that has been going on in this town lately has had a “train wreck” element to it (no matter which side of the aisle you favor). You don’t want to watch, but it’s difficult to look away. Having been safely ensconced inside the beltway bubble for almost a decade, toiling first as a reporter on Capitol Hill, then with an industry trade group, I’m not unfamiliar with the concept of“staying on message.” Often infuriating for a reporter, it’s an imperative on the communications and public affairs side of the equation (just ask any press secretary whose boss has wandered horribly off message about the cleanup that often takes place after). Perhaps I haven’t been in D.C. long enough, and maybe my naïvetéhasn’t quite worn off yet, but no matter what the message is, the words should be backed up by action—or at least by a modicum of sincerity. Credibility demands nothing less. Choosing your words carefully shouldn’t imply duplicity.

As I’ve listened to different representatives from the U.S. Food and Drug Administration (FDA) recently, it occurs to me that the agency is doing—for the most part—a good job of sticking with a theme, but I’m not so sure the medical device industry is buying it. Take, for example, recent comments by the director of agency’s Center for Devices and Radiological Health (CDRH), Jeffrey Shuren. Shuren is affable, approachable and has crisscrossed the country to talk about the changes being made within CDRH that he and other FDA officials claim will make medical device approvals more transparent and expedient. During a recent medical device meeting at the University of Minnesota in Minneapolis, Shuren addressed the topic of medical device innovation from the agency’s perspective.

“The medical device development is an ecosystem with shared responsibility. If it is to remain healthy, we need a strong industry. We need a strong research system, and we need a strong FDA,” Shuren told the audience. “We believe that the U.S. is the global leader in medical device development and innovation. But we won’t retain that position for long if we don’t address current challenges to innovation.” Among the challenges he noted were financial markets, reimbursement and, of course, regulatory.

It’s hard to argue with that.

“We are charged with protecting public health,” he continued. “But the other side of our mission is to promote public health by facilitating medical device innovation. But we, too, face challenges. Science is continually evolving. We have to be prepared for it. Existing regulatory pathways were created more than 30 years ago, which means we have to go back and fine tune the process to evaluate today’s new technology…We’re not raising these issues. Technology is raising them. We know that [the current system] isn’t robust enough to answer all the important questions, and we want to make it work.” Shuren also described an open-door policy where medical device firms can visit and work with FDA to solve new device submission issues to ensure a smooth path to ultimate FDA approval. He even noted that requests for meetings have risen, but that the agency doesn’t always have the manpower to take as many as it would like in a timely fashion.

Again—difficult to find fault with that. Sounds good, right? And indeed, I’m sure the agency is diligently working to improve its internal systems and its external outreach with industry.

But industry’s reaction has been the flip side of the coin. One medical device executive at the Minneapolis meeting said he appreciated Shuren’s and the agency’s good intentions, but he “just wasn’t seeing it” at other agency levels. “It all sounds good, but when it comes time for my company to deal with FDA about a problem or a submission, it’s a whole different story,” he said. “It depends upon who is in charge of your review, the regional office—any number of things. I’m not sure that what [Shuren] is saying has trickled down to the rank and file.”

Following an FDA panel discussion at a recent industry trade association meeting in Florida, another OEM told me that despite the “rhetoric”he’s still not experiencing a change in his interactions with the agency. “We get a lot of warm and fuzzy from some of the higher-ups, but some of those‘let’s work together to make things better’ feelings seem to disappear in day-to-day dealings. It isn’t predictable.”

Change takes time, and Shuren hasn’t been at the helm very long. It seems, however, that communications and expectations among industry and the FDA aren’t quite in lockstep—despite the town hall meetings and other outreach. As the user fee program comes up for authorization again soon, perhaps some of these issues will be addressed. I would be interested in hearing feedback from Orthopedic Design & Technology readers about your experiences with the FDA, as well as perceptions and expectations of what the future holds.
So please keep those emails coming.

On an internal note about our own improvement activities at ODT, I’m pleased to welcome Laura Sassano to the team as senior associate editor. You’ll see Laura soon at industry events and hear from her as she reports on the events of the day. She offers a wealth of experience and enthusiasm that I know will be evident in the quality of content you read.

Christopher Delporte

Group Editor