The Voice From The Top: Henney's "Recall" Signals A New Era at FDA

January 1, 1999

3 Min Read
The Voice From The Top: Henney's "Recall" Signals A New Era at FDA

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


Jane Henney begins her term as the new FDA commissioner by restating her commitment to ongoing agency reforms.

According to Genesis, God's first day on the job encompassed the creation of heaven, earth, light, day, and night from a stew of primeval darkness. Jane Henney had an arguably more modest agenda for her first day as the new FDA commissioner, which began in a well-lit ballroom with an address to the plenary session of the annual educational conference of The Food and Drug Law Institute (FDLI) in Washington, DC.

The mood in the room was expectant but upbeat: these days, not even FDA's harsher critics would characterize the agency—like the world in the beginning—as "without form, and void." But the anticipation in the crowd was an indication of the importance accorded the voice from the top—an acknowledgement that the future of FDA and of the industries it regulates will undoubtedly be shaped by Henney's clarity of purpose and steadiness of hand.

In returning to FDA for a second tour of duty, Henney rejoins an entity that she claims is "vastly different from the agency I left four years ago." What she described as her "lead priorities" reflect just how much the landscape has changed. "First and foremost," said Henney, she is committed to "the full and effective implementation of FDAMA, both in letter and in spirit."

While commending FDA for its implementation efforts to date, Henney specified that those efforts must continue to respect section 406(b) of the act—the provision that requires FDA to remain in active consultation with all "stakeholders" affected by its mandate. She was also explicit about the obligation to equate principles with results, not good intentions, and to judge public officials accordingly: "Policy is not what is planned, but what happens."

Henney's second priority will be "to strengthen the science base of the agency"—an oft-repeated pledge about which, Henney told the audience, she is entirely serious: "I assure you, this is not rhetoric." Among other measures, this will entail improved recruitment and retention of skilled personnel and better use of non-FDA government scientific resources. It is increasingly critical, said Henney, that FDA has adequate "scientific sophistication" to understand and regulate the multitudes of new products sure to emerge from a host of still-developing technologies. Current budgetary constraints will make a daunting goal even more difficult, given that the agency's "core budget has not risen in concert with its new responsibilities." (Sen. Orrin Hatch (R-UT), another speaker at the session, called FDA's budget "a sham.")

Even in the face of such potential problems, Henney maintains, "the best organizations find ways to constantly improve themselves," and she obviously intends for this process to prevail at the agency. What Henney terms her "forte," the reason she was "recalled" to FDA, is "the administration of large health-care organizations." But this impersonal-sounding phrase belies a staunch belief in the force of personality. What is always required, Henney says, is "much more than management. . . . It's really about leadership."

This issue of MDDI marks the debut of our special Medical Plastics and Biomaterials section. Each month, the dedicated MPB section will present in-depth technical articles and news devoted specifically to materials technology, exploring the full range of plastics and other biomaterials (ceramics, metals, composites, biologics) used in manufacturing and packaging medical products.

We're pleased to bring you something new for the New Year, and extend our best wishes for 1999!

Jon Katz
[email protected]

Copyright ©1999 Medical Device & Diagnostic Industry

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