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.
Close [ x ] More from GovExec

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

  • Sponsored by Brocade

    Best of 2016 Federal Forum eBook

    Earlier this summer, Federal and tech industry leaders convened to talk security, machine learning, network modernization, DevOps, and much more at the 2016 Federal Forum. This eBook includes a useful summary highlighting the best content shared at the 2016 Federal Forum to help agencies modernize their network infrastructure.

  • Sponsored by CDW-G

    GBC Flash Poll Series: Merger & Acquisitions

    Download this GBC Flash Poll to learn more about federal perspectives on the impact of industry consolidation.

  • Sponsored by One Identity

    One Nation Under Guard: Securing User Identities Across State and Local Government

    In 2016, the government can expect even more sophisticated threats on the horizon, making it all the more imperative that agencies enforce proper identity and access management (IAM) practices. In order to better measure the current state of IAM at the state and local level, Government Business Council (GBC) conducted an in-depth research study of state and local employees.

  • Sponsored by Aquilent

    The Next Federal Evolution of Cloud

    This GBC report explains the evolution of cloud computing in federal government, and provides an outlook for the future of the cloud in government IT.

  • Sponsored by Aquilent

    A DevOps Roadmap for the Federal Government

    This GBC Report discusses how DevOps is steadily gaining traction among some of government's leading IT developers and agencies.

  • Sponsored by LTC Partners, administrators of the Federal Long Term Care Insurance Program

    Approaching the Brink of Federal Retirement

    Approximately 10,000 baby boomers are reaching retirement age per day, and a growing number of federal employees are preparing themselves for the next chapter of their lives. Learn how to tackle the challenges that today's workforce faces in laying the groundwork for a smooth and secure retirement.

  • Sponsored by Hewlett Packard Enterprise

    Cyber Defense 101: Arming the Next Generation of Government Employees

    Read this issue brief to learn about the sector's most potent challenges in the new cyber landscape and how government organizations are building a robust, threat-aware infrastructure

  • Sponsored by Aquilent

    GBC Issue Brief: Cultivating Digital Services in the Federal Landscape

    Read this GBC issue brief to learn more about the current state of digital services in the government, and how key players are pushing enhancements towards a user-centric approach.

  • Sponsored by CDW-G

    Joint Enterprise Licensing Agreements

    Read this eBook to learn how defense agencies can achieve savings and efficiencies with an Enterprise Software Agreement.

  • Sponsored by Cloudera

    Government Forum Content Library

    Get all the essential resources needed for effective technology strategies in the federal landscape.


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