May 1, 1999

3 Min Read
Casting an Interactive Web: Henney Seeks Real-Time Input from Industry

Medical Device & Diagnostic Industry Magazine
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An MD&DI May 1999 Column

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Will new media help implement FDAMA's mandate for engagement and interaction between FDA and device companies? A recent event tests a powerful mechanism for dialogue.

Marshall McLuhan's dictum from the 1960s that "the medium is the message" is being validated to an extravagant degree in the Internet Age. From chat rooms to the stock valuations of Web-based enterprises, the allure, promise, and underlying symbolism of the medium itself have become as important as the actual content offered.

The same could be said about the recent FDA happening—to use another sixties tag—that took place on April 28. Billed as "an interactive satellite teleconference/Webcast" and held in conjunction with regional public meetings, the event featured commissioner Jane Henney and a lineup of her chief deputies doing essentially what the session title announced: "Talking With Stakeholders About FDA Modernization." The purpose of the gathering was "to discuss the agency's progress in implementing FDAMA and to seek additional input on specific FDAMA performance targets."

A small studio audience included representatives from various industry and professional organizations, but the real audience comprised the numberless participants at their PCs who were urged to phone or fax in their questions. And although a range of topics was addressed, the real subject seemed to be the medium and format of the presentation, which exemplified FDAMA's mandate for engagement and interaction. Despite the intermittent technical distractions—
participants moving as if underwater, words and lips out of synch—the transforming image was that of the FDA commissioner available to any interrogator across the country. It was only a few short years ago, one remembers, that FDA issued a six-page memorandum telling its reviewers how to stop talking with industry on the phone.

Henney did say some intriguing things, several of which are likely to raise industry eyebrows. In her lobbying for an "adequately resourced" agency, she emphasized the erosion of "core program" funding, even with modest budget increases the last few years and an 18% raise slated for 2000. (According to Henney, for example, key scientific personnel at FDA have not been able to attend relevant professional meetings for three or four years.) Citing the "very successful experiment" of drug user fees, she noted the "opportunity" for user fees for devices, contingent upon industry and Congressional support and a firm tie-in to specific performance goals. While acknowledging that manufacturers were "not wildly enthusiastic" about user fees, Henney explained that the fees were simply another "way of giving [device companies] the resources they need." The fact that these resources for industry would have to be purchased with resources from industry somehow got lost in the soothing rhetoric.

In response to a question about regulatory harmonization and the globalization of today's market, Henney brought up another "key opportunity" not likely to be at the top of industry's wish list: that of "exporting FDA's high standards worldwide." And she was frank in lamenting the headache for the agency caused by the FDAMA provision requiring the "least burdensome" means of establishing device effectiveness. She would have been "a happier camper," Henney told a caller, had wording like "most reasonable"—with its overtones of cooperation—been used instead.

The commissioner appeared committed to perpetuating subsequent on-line exchanges during the implementation of FDAMA, pledging to carefully evaluate the usefulness of the teleconference and to budget for similar events in the future. Her hope is clearly that the new medium itself can help fulfill both the letter and spirit of the new law.

Jon Katz

[email protected]

Copyright ©1999 Medical Device & Diagnostic Industry

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