Acting FDA Leader In Limelight

It's been almost a year since David A. Kessler--the high-profile, long-serving and sometimes controversial commissioner of the Food and Drug Administration--decamped to Yale University's medical school. But Kessler's successor, oncologist Michael A. Friedman, isn't allowing much drift.

In fact, FDA has had an unusually active couple of months, even though Friedman is in his position only on an acting basis and the agency's long-term leadership plans remain murky. Since August, FDA has not only handled several food and drug crises but also advanced or settled a number of long-contentious issues. Among them:

• FDA proposed requiring children's usage to be labeled on both new and old drugs, which would in some cases mean mandating new tests to gauge safe pediatric doses.
• It proposed a rule to ensure that women are not routinely excluded from early studies of drugs for life-threatening diseases.
• On an interim basis, FDA allowed prescription drug makers to advertise their products' benefits on television and radio, as long as side effects and warnings were cited and viewers were directed to details elsewhere.
• Following years of controversy, FDA allowed the irradiation of red meat.
• And late this year, with the agency's cooperation, President Clinton signed a major FDA overhaul, including reauthorization of the Prescription Drug User Fee Act, which allows FDA to add staff reviewers by assessing drugmakers the extra cost.

"It's been a very busy time," Friedman said in an interview. "The agency as a whole feels the public expects us to move forward, so we're going to respond in that way. There are so many talented people and good ideas here that the challenge is to prioritize them, which calls for cooperation and discipline within the agency."

Jim Benson--who spent most of 1990 as acting FDA commissioner--said Friedman is "doing a good job of orchestrating the agency and letting important public policy decisions come to fruition as appropriate, which is what the leader of the agency should be doing." Benson is now executive vice president of the Health Industry Manufacturers Association.

And Kessler, interviewed from New Haven, added that "there's a very strong team in place that's enormously talented and that knows how to get things done. In some ways, that team can sustain an agency [without a permanent leader] for a good deal of time."

Just how long remains to be seen. For awhile, Friedman and his predecessor as deputy commissioner for operations, Jane E. Henney, had been considered the two finalists for the top job. But Friedman--said to be well-liked by Health and Human Services Secretary Donna E. Shalala--recently has been dogged by rumors that Sen. Edward M. Kennedy, D-Mass., would rather see someone else in the post. Now, most agree that all bets are off.

Kennedy's office declined to comment on Friedman, and health-oriented public interest advocates did not return calls. Caroline Smith DeWaal, the food safety director at the Center for Science in the Public Interest, said that "the evidence simply isn't in on what kind of commissioner Dr. Friedman would be."

But if Friedman continues in the job--or gets it permanently--many industry and FDA officials will be pleased. Kelly Johnston, the executive vice president for government affairs and communications at the National Food Processors Association, said he was especially impressed with Friedman's strong response to a poisoned-strawberry outbreak, an issue that's far outside Friedman's professional experience.

"We've been extremely pleased with Dr. Friedman's leadership, not because we agree with him on everything, but because he at least has given the agency leadership and offered a pretty seamless performance after David Kessler," he said. "I've been in this town for 18 years, and I've never seen anybody in an acting job act as professionally as he has. He does among the best jobs I've seen of hearing people out and keeping an eye on the goal line."

Friedman's relatively high profile style of leadership is rare for acting officials, said Bill Gadsby, a fellow at the National Academy of Public Administration. Historically, he said, interim bosses "usually continue the policies of the former head, as opposed to making radical changes--especially when it's a career person," such as Friedman, who became a senior National Cancer Institute official in 1985.

But though Friedman served under Kessler for more than a year, officials agree that his time at the helm has enabled him to escape Kessler's shadow.

For instance, sources said Kessler opposed easing direct-to-consumer advertising rules and felt lukewarm about several aspects of Congress's FDA reform bill. And while Kessler had asked FDA scientists to study irradiation, he never came close to approving it for red meat, even after the deadly Jack-in-the-Box hamburger outbreak in 1993.

Sources said that the recent initiatives on women in testing and pediatric labeling advanced because they were strongly backed by the White House, while the FDA reform legislation moved ahead because it had the support of Congress and industry. Direct-to-consumer advertising and meat irradiation are thought to have been resolved because industry lobbyists presented a united front while critics put up late or halfhearted opposition.

But FDA's flurry of activity may also stem from Friedman's style, which is said to be less confrontational than Kessler's. Johnston, a Capitol Hill aide for much of Kessler's tenure, recalled that "Kessler came in guns a-blazing." His image eventually improved, Johnston said--but by contrast, "Friedman is anything but a lightning rod."

One fellow lobbyist agreed. "The most apparent difference to me is that he is a personable man, with warmth and feeling," the lobbyist said. "Kessler was aloof, more protocol-oriented, with a don't-get-too-close-to-me disposition. Kessler also came on with such a strong enforcement position that he was not anxious to talk to [industry] people. Friedman is much more approachable."

Indeed, said the lobbyist, he felt so comfortable with Friedman that he would be happy to have him as his personal physician.