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Originally Published January 2001

Editor's Page

Addressing the National Press Club on a politically historic day, FDA Commissioner Jane Henney outlines the agency's fundamental operating principles for the years ahead.

Approximately one month before you'll be reading this, FDA Commissioner Jane Henney delivered a major summary address that resembled the proverbial tree falling in the midst of an uninhabited forest. In other words, unless you're in the habit of checking in at the Web site of the National Press Club, it's unlikely that you heard about it. You see, Commissioner Henney's appearance at an NPC luncheon in Washington took place on December 12, when the attention of every citizen—let alone every reporter—was riveted on the impending Supreme Court decision that would finally decide the presidential election that same evening. On a day that there was only one story, it was ironic that Henney would open her talk on "FDA: Preparing for the 21st Century" by touting the agency's high public profile and the fact that "it seems we're always in the news." But if the Commissioner was decidedly overshadowed on this occasion, she nevertheless delivered a number of intriguing indications regarding FDA's future that deserve to be brought into the light.

Citing a recent survey conducted by the Pew Research Center and Princeton Research Associates, Henney maintained that FDA receives unusually positive marks from the public it serves. Although only 26% of consumers, health professionals, and industry officials said that they "trusted the federal government to do what is right," from 72 to 85% of those same respondents stated that they "trusted FDA to make the right decision." To retain this confidence in an era of unprecedented change, said Henney, the agency must follow what the Commissioner referred to as "four fundamental principles."

The first of these principles is that FDA must continue to "ground decisions in science." The Pew survey found that 75% of respondents believed that FDA bases its decisions on "good science." Henney admitted that sustaining this capability in the face of revolutionary developments in genomics, proteomics, nanotechnology, robotics, and artificial intelligence—that is, having the expertise to evaluate devices that will incorporate these technologies—represents a major challenge for FDA. "If we are not scientifically strong," she said, "our decision-making will become risk averse, or, what is worse, simply wrong."

FDA's second guiding principle, according to Henney, is "increased openness and transparency." Critics of the agency might be surprised at the Commissioner's claim that FDA "enjoys a worldwide reputation" for promoting such open policies as public-advisory committee meetings, consumer-affairs offices, and notice-and-comment rule making. Henney emphasized that the agency's Web site—which contains some 110,000 documents and receives more than 60,000 visits per day—is now posting specific advance information on upcoming advisory committees, transcripts of advisory-committee meetings, more-extensive information following product-approval decisions, and details regarding enforcement actions such as warning letters.

Augmenting FDA's effectiveness through "leveraging" is Henney's third principle, one that "allows FDA to bring a wider range of scientific thinking to bear on public health issues." Examples cited by Henney include work with private and state accreditation bodies to implement the Mammography Quality Standards Act.

The fourth and final principle entails taking the agency on the road to "expand the traditional mission of FDA beyond that of domestic consumer protection." Pointing out that FDA has historically fostered an international presence, Henney noted the imperative of economic globalization and the nation's aggressive trade policy in driving FDA's involvement in various regulatory harmonization efforts. Whether the agency is setting standards, organizing compliance programs, or resolving disputes, Henney envisions an FDA with "enormous potential for improving the public health worldwide."

Jon Katz
[email protected]

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