Originally Published MDDI August 2004

Reflections



A longtime MD&DI columnist reflects on what he sees as the most significant developments in the last quarter century of medical device regulation.

James G. Dickinson

The last quarter century has seen FDA implement numerous programs and regulations, many of which have greatly affected the medical device industry. Some people, I'm sure, would pick FDA user fees as the most significant development in that time—but I think it's still too early to make that distinction. That said, I have chosen medical device reporting (MDR) regulations as the most significant regulatory development of the past 25 years.

The History of MDR

Twenty-five years ago, FDA and the medical device industry were embroiled in a controversy that still has troubling echoes. Should the industry be compelled to report to FDA medical problems arising from, or potentially associated with, the use of its products? Debates about whether, and to what extent, the industry should report such problems to the agency are still ongoing.

When a regulatory requirement to report problems was finally brought into being on January 1, 1985, it had been preceded by about six years of concept papers, controversy, congressional hearings, public meetings, and notice-and-comment proceedings.

Industry's compliance with this regulation was so poor that Congress stepped in. After sensational hearings that left both FDA and the industry looking bad, it passed the Safe Medical Devices Act of 1990, which was then amended in 1992. These, in turn, led to the present MDR regulation, which became effective on July 31, 1996.

I have always wondered why this dynamic, far-flung industry should object to filing the same kind of prompt experience reports about its products that drug manufacturers are required to file about their products. Of course, when it's expressed that way, few in the industry would agree that they do, or ever did, resist reporting. But the industry's behavior, when viewed through the prism of a 25-year backward glance, suggests otherwise.

In addition to being dynamic, the medical device industry is amazingly diverse—far more so than the more homogeneous biopharm industries. This, I suspect, helps explain why the industry has been slower to embrace regulatory commitments than the other medical product companies regulated by FDA.

Another reason could be the different nature of most devices. Even implants don't usually perform their roles as intimately as drug and vaccine molecules that may visit or work in every cell of the body. Thus, the connection between the device and any unwanted consequences may be harder to establish than for a drug or a biologic agent.

A pertinent current example is the battle between CDRH and TMJ Implants over 17 unreported “events” that FDA investigators found in the company's files. The company says they were mostly progression-of-disease or other effects unrelated to the company's implants. FDA says the company can't say that unless the reports are filed and duly investigated.

But, of course, once filed, a report becomes public property and open to competitive exploitation in the marketplace. That is a powerful deterrent, leading companies to file no more than the least amount necessary under a law—especially since these reports can be read selectively.

Multiply this skirmish by thousands of other, less-publicized ones over the past 25 years and you may gain some idea of how sensitive the issue of MDR regulation can be.

The regulatory and statutory requirement to report adverse patient experiences has always been resisted. It was born in the fevered environment of malfunctioning or fraudulently sold implanted devices 25 years ago (e.g., Dalkon Shields, Bjorke-Shiley heart valves, intraocular lenses). So it seems the industry has good reason to fear punitive product liability damage judgments.

But whatever the good reasons, the industry's resistance has over the years amplified the suspicion and skepticism that habitually reside in the hearts of regulators. This is especially true if congressional overseers and the media are flaying them for being lax. Indeed, before Republicans took over both houses of Congress, that seemed to be FDA's constant plight.

Other Notable Developments

While the requirement to report is, in my view, the most significant regulatory development of the past 25 years, other changes have also made a significant difference in the way industry and regulators relate to each other.

Among these is the informal change in the FDA culture that was ushered in during the Reagan administration, accelerated under Clinton, and given full-speed-ahead impetus by the second Bush administration.

This is the doctrine of industry as an FDA “constituent” or “stakeholder.” User fees really give this phenomenon enormous power. How can a bureaucrat exhibit his or her customary arm's-length skepticism when the law of the land demands cooperation, facilitation, and a unified common objective (e.g., the fastest possible route to market)?

When the commissioner of FDA promises industry that his door is always open to them, you know that the old adversarial relationship has passed into history. At this year's AdvaMed annual meeting, Lester Crawford even invited those in the device industry to call him at home! “We've had some great-communicating commissioners, but I'm still the only one that ever has had a listed phone number—so give me a call,” he said.

I happen to be among those who think such chumminess isn't necessarily a good thing. As a former Democratic FDA chief counsel was fond of saying 25 years ago, there should be “a healthy tension” between regulated industry and FDA.

It's a bit like wearing business clothes instead of jeans or shorts to the office. It builds respect. The rediscovery of the old truism that “familiarity breeds contempt” may also cause FDA's new collegiality with industry to acquire some respectful distancing.

The Future

A retrospective on the past 25 years might not be expected to look ahead. However, I predict that regardless of the outcome of the presidential election in November, sooner or later some of that old “healthy tension” will return to FDA-industry relations. It might be the result of a judicial opinion, or a political directive from on high, or a change in statute—but it will surely come. 

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