Originally Published EMDM January/February 2005
A NOTE FROM THE EDITOR
FDA and the Known Knowns
I think we would all agree that reinventing the wheel is not an efficient use of resources. Yet, many medical device companies do so on a routine basis. That is the view of Stephen Ferguson, chairman of the Cook Group, the largest privately held device company in the United States.
For the past 15 years, Cook has been on a mission to allow “FDA to know what it knows.” Data culled from previous applications, argues Ferguson, should be applied to new submissions. “If stainless steel has been shown to be biocompatible, why should we need to reprove this property when the material is used in a new device?” he asks. Ferguson also calls for making clinical data public. “That information should be subjected to public scrutiny,” he says. Greater transparency would be helpful not just to the end-users but to the scientific community and manufacturers, he adds. (Drug companies take note.)
Cook’s proposals got a fresh airing at a recent public hearing held by a Health and Human Services department task force in Washington, DC. Ferguson and other attendees were invited to discuss ways in which public health agencies in the United States could work together to spur medical innovation. Members of the task force reportedly were quick to embrace Ferguson’s ideas. The reaction from industry and its representative associations was less enthusiastic.
Making submissions data available has obvious benefits, argues Ferguson.
It would reduce unnecessary bench and animal testing, he notes, and would require fewer patients for clinical trials. The down side is equally obvious:
data sharing could be advantageous to competitors. Cook’s resolute lobbying has achieved some results, primarily in the form of watered-down compromises, according to Thomas A. Connaughton, vice president, legislative affairs, at Cook.
When the Safe Medical Devices Act of 1990 was being drafted, Cook recommended that FDA be free to use information gained from applications, other than trade secrets, at any time. Industry was opposed to the idea, but it reached a compromise in the form of the “four of a kind” provision. This allowed FDA to use information from applications, but only after the agency had approved four devices of a particular type. That proved to be unworkable, says Connaughton. “FDA was supposed to publish a list of [applicable] device types, but it never did,” he notes. That clause was replaced a few years later with the “six-year information” provision. “This lets FDA use information obtained in an application six years after approval of the device. This provision has proven to be equally unworkable,” Connaughton adds.
In a cynical age, some people will question Cook’s seeming altruism. After all, this company has developed a number of novel technologies. Making the firm’s submission data public would inevitably benefit its competitors. Ferguson, however, shrugs off the concern.
“Sure, people tell me that this will hurt our strategic interests and business position,” says Ferguson. It might, in fact, help the competition in the short term, he acknowledges. “But industry, as a whole, ultimately would benefit, because [data sharing] creates a more efficient system,” says Ferguson. “If your actions are driven by what’s good for the patient, then everything will balance out in the end.”
Believers in Darwinian capitalism, who seem to be enjoying a renaissance these days, might beg to differ. As for me, I find it encouraging that some captains of industry are willing to take their eyes off the balance sheet long enough to recognize that there is more than one bottom line when it comes to the business of healthcare.
Norbert Sparrow
Copyright ©2005 European Medical Device Manufacturer
