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.

Stay up-to-date with federal news alerts and analysis — Sign up for GovExec's email newsletters.
FROM OUR SPONSORS
JOIN THE DISCUSSION
Close [ x ] More from GovExec
 
 

Thank you for subscribing to newsletters from GovExec.com.
We think these reports might interest you:

  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

    Download
  • The Big Data Campaign Trail

    With everyone so focused on security following recent breaches at federal, state and local government and education institutions, there has been little emphasis on the need for better operations. This report breaks down some of the biggest operational challenges in IT management and provides insight into how agencies and leaders can successfully solve some of the biggest lingering government IT issues.

    Download
  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

    Download
  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.

    Download
  • Ongoing Efforts in Veterans Health Care Modernization

    This report discusses the current state of veterans health care

    Download

When you download a report, your information may be shared with the underwriters of that document.