Burlington to HIMA: A Challenge, or a Threat?

Originally published April 1996

Relationships between FDA and the medical device industry are not supposed to be cozy. Even when the two are cooperating, their interests should never fully align. Indeed, it's a mark of a healthy regulatory relationship when each side regularly challenges the other without rancor or fear of retribution.

Until very recently, I'd have said that industry and FDA were steadily moving toward this ideal state. But after hearing Bruce Burlington's address to the annual meeting of the Health Industry Manufacturers Assocation last month in Palm Beach, FL, I'm not so sure.

At the end of his speech, the head of FDA's device center presented HIMA members with what he called a challenge, but most of the audience interpreted as a threat. "Is HIMA," he asked, "going to be an adversarial organization to the FDA? Are you going to devote your time and energies, essentially exclusively, to lobbying the Hill for a new statute that you think you'll like better?

"We need to be interacting constructively," he continued, "as opposed to strictly in-your-face, adversarial, back-and-forth bickering about the [application review time] numbers and . . . how to position yourself in terms of members of Congress." Would FDA be better served, he wondered out loud, by working with regional industry groups and individual companies rather than with HIMA?

Some in the audience took his remarks as an attack on their First Amendment rights, but I think this is too grand an interpretation. Rather, I believe he meant that, to his mind, it is not possible for HIMA at once to lobby for an overhaul of the device law and to work with FDA to improve the current system.

Undoubtedly there is some logic behind his assertion. From his perspective, it may well appear that the temptation for HIMA to impede or discount internal agency reforms in order to improve chances for statutory reform is irresistible. His concern, as he put it, is to be sure that when FDA develops policies with HIMA, "we are really sitting down at the table" and not posturing for Congress.

I do not know whether Burlington's doubts about HIMA's willingness to support his internal reform efforts are justified. But given that statutory reform is far from a sure thing, it is clearly in HIMA's and industry's interest to support any policy changes that will improve agency operations.

Underlying Burlington's concerns appears to be a conviction that the current device law is basically sound. As he told the audience, "Those who blithely call for the wholesale replacement of our current system, I don't believe, have looked at all the ramifications of that. FDA's current system of regulation . . . is not today nearly so broken as many of you characterize it."

Perhaps it isn't. But it should not be assumed that those who see the 20-year-old law as fundamentally outmoded cannot both work to change that law and simultaneously support attempts to implement its current requirements more efficiently.

In the aftermath of Burlington's address, it appears that each side sees what the other considers to be beneficial challenges as deleterious threats. Nothing good can come of this situation.

As HIMA president Alan Magazine said in his response to Burlington's comments, HIMA and FDA in fact have "a pretty close and pretty positive relationship on the specific issues that affect the industry." In order to preserve this relationship, both sides must ensure that their challenges to each other are not in fact veiled threats. True challenges in this vital relationship will ultimately bene- fit health care in the United States and the world; threats can only damage it.

John Bethune