• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

A Decade in the Director’s Office: An Interview With CVM Director Dr. Stephen F. Sundlof - Part 2

FDA Veterinarian Newsletter May/June 2005 Volume XX, No III

Part two of a two-part series

This is the second part of a two-part series based on an interview with Stephen F. Sundlof, D.V.M., Ph.D., Director of the Center for Veterinary Medicine, about the changes he brought to the Center when he became director more than 10 years ago. The first part of the series, published in our last issue, dealt with science and policy issues. In this second part, Dr. Sundlof talks about administrative changes at CVM.

When you first came to CVM more than a decade ago, you thought that improvements could be made in the way the Center works. Ten years ago, you said you envisioned a flatter management structure, and that you would have front-line reviewers offering improvements and taking ownership of the process. How would you describe the situation in the Center now compared with when you started?

Flattening, or reducing the layers, in CVM’s management structure was part of the “Reinventing Government” initiative—a component of the managerial philosophy at that time, which encouraged development of less hierarchical organizations by removing management layers.

We started the flattening process by removing an entire layer of management. We completely eliminated supervisory branch chiefs, exchanging them for non-supervisory team leaders, who managed the day-to-day work of the team. All supervisory responsibilities were assigned to the division directors.

Now that we have considerable experience with the de-layered management structure, we are evaluating the strengths and weaknesses of this business practice. This evaluation is consistent with the current move toward rethinking government processes to determine what works best and is most efficient.

For example, we have discovered that as our review divisions became larger it was virtually impossible for the division directors to provide sufficient supervisory time to each individual staff member. Therefore, we are now in the process of converting team leaders back into supervisory branch chiefs. Live and learn.

Changing CVM’s culture

What would you say has been the greatest challenge of your tenure at the CVM?

I think the greatest challenge has been trying to change the culture at CVM.

Shortly after I arrived at CVM, I began a strategic planning process. I hired two management consultants to help identify where the Center was strategically and where it should be headed.

The two conducted interviews and focus groups with nearly everyone in the Center and unearthed a litany of issues that people disliked about the organization. The consultants organized similar complaints in discrete groups and produced a thick book on the negative aspects of working at CVM. We called it the “Bluebook.”

Armed with this new information, senior management set out to build a strategic plan aimed at addressing the various complaints that surfaced through the focus groups. After living with our new strategic plan for a couple of years, it became apparent that a plan which attempts to be all things to all people is in no way strategic, and is doomed to failure. It is difficult to develop a positive, forward looking plan if you just focus on what’s wrong. Beware of consult-ants offering simplistic solutions to complex business problems. We decided to start again from scratch.

Shortly after joining the FDA in 1994, I enrolled in a leadership development program at the Federal Executive Institute in Charlottesville, VA. I was particularly influenced by a course titled Building High Performance Organizations. The course offered a much more holistic view of the organization than strategic planning could encompass. It emphasized sound business planning (including strategic planning) and management principles. But in addition, it focused on building a healthy work culture based in shared community values. I decided to explore the possibility of modeling CVM in accordance with the High Performance Organization (HPO) principles.

To begin the change process, we hired Dr. John Pickering, President of the Commonwealth Center for High-Performance Organizations, Inc., in Charlottesville. The Commonwealth Center for HPO is a management consulting firm that works with executive teams in both public and private sectors to improve organizational performance and manage large-scale organizational change. John Pickering, a former professor and senior-level Federal executive, was well positioned to help us move toward becoming a high perform-ance organization.

Dr. Pickering and his associates at first found themselves referring to CVM as a good example of what not to do in management. One of his first recommendations, which was pivotal to the success of the culture change, was that we engage a fulltime, HPO-savvy, organizational development expert to help us. However, we quickly learned that there was not an oversupply of good organizational development consultants we could afford.

Dr. David Grau, who was then in charge of training at CVM, was identified as an excellent choice to become our HPO expert. Dr. Grau participated in the Organization Development and Leadership Coaching programs at Georgetown University, and has become CVM’s instructor, spokesman, and leader for the HPO process.

I believe that the HPO model has been the key in building a vibrant and engaged work culture and solid business processes. Over the past six years, we have seen not only positive change, but a real sense that things are being done differently because of HPO.

In your interview 10 years ago, you also said that you wanted to build a workforce with a strong sense of the Center’s strategic mission/vision. Has that -happened?

A key to CVM’s organizational values and our leadership philosophy is the belief that the people who work at FDA—and at CVM in particular—do so because they intrinsically value the Agency’s mission. They are motivated by what the Agency does and by the fundamental nature of their work.

Each staff member at CVM has knowledge to share with the rest of the organization. The senior leadership team wants to make the richness of that knowledge an integral part of our decision-making process. Our goal is to make collaborative decisions at CVM, using the values and knowledge of all of our employees.

The HPO model has diversity and knowledge as centerpieces. Under the HPO model, decisions are made by a team reaching consensus, if possible. We revert back to the hierarchical mode only when necessary. It is important that decisions made by CVM’s senior leaders—including those I make—take into account the perspectives of the diverse parts of our organization and are as fully informed as possible. To the extent possible, we try to take off our positional hats when we are in the decision-making mode so we can involve group members as equals in discussions and decisions.

Employer of choice

For the past six or seven years, we have been working hard to understand and apply this HPO model, and I think it has given us some real benefits.

One of the goals we identified through HPO is for CVM to be the “employer of choice” in government. HPO has been an important component in making CVM a desirable place to work. HPO has helped to make us more productive, has improved the the workplace environment, and has improved our ability to attract and keep highly qualified people.

FDA and CVM have employed a number of survey instruments to gauge employee satisfaction. The most recent is FDA’s “Q12” survey, conducted by the Gallup Organization, the national polling firm. CVM’s scores on the 12 questions in the survey were significantly higher than those for any other major FDA component. With 87 percent of the Center participating in the survey, employee engagement was high (defined as those involved in and enthusiastic about their work) as was satisfaction with the organization as a place to work. These results, in stark contrast to the results of the “Bluebook” interviews 10 years ago, are the result of years of dedicated effort toward becoming a high performance organization.

Turnover is another important measure of our success. I’m proud to say that we have a very low turnover rate—the lowest of any FDA center. Employee retention, which is a very telling sign, is excellent.

Management tools

What other management changes have you -instituted?

Two other new initiatives we implemented are Activity Based Costing and Activity Time Reporting. We have expected productivity at CVM to increase over time, but until now, we have not had real ways to measure that. These initiatives are too early in their implementation to have generated enough data to reach any conclusion with regard to productivity, but early indications suggest that they are useful tools for collecting productivity measurement data.

Challenges of a regulator

What have you learned since coming to CVM that has had a significant impact on you and how you do your job?

I have to confess that prior to becoming CVM Director I did not fully understand the complexity of -making scientific policy and regulating industries. I naively thought that policy decisions would be clearcut, based on unambiguous science. I quickly learned that was hardly the reality. Unambiguous science, it turns out, is a very rare commodity. Imperfect humans with imperfect technology are responsible for scientific research and technology. All science has some inherent uncertainty associated with it, and any decision based on science can be challenged because of that uncertainty.

In a regulatory setting, policy making sometimes takes on an adversarial quality, in part because different stakeholders hold differing values and assumptions. As a result, the Agency often finds itself at odds with industry or consumers because of disagreements about what the science says and how it should be applied in making policy.

Another factor that influences policy is the degree of risk we are willing to take. As regulators who are charged with protecting the public and animal health, we tend to be more risk averse than the regulated industry that is impacted by the cost of the risk reduction. Industry representatives often want to see evidence that harm will occur before the industry adopts more costly practices, whereas regulators seek to prevent any harm from occurring, thus barring the generation of direct evidence of harm.

Managing the resulting tension between the regulators and regulated industry is a large part of this job. I think that the honest debate that results is healthy and the result is usually good decision-making.

Industry trends

In your interview 10 years ago, you expressed concerns about the economic pressures on the animal pharmaceutical industry and what that might mean for the ability of companies to develop animal drugs. How would you describe the situation in the industry currently, and what might it portend for the future of the industry and the Center?

This is my interpretation, of course. But what I’ve seen in the last 10-plus years is a consolidation of the animal drug industry that mirrors the consolidation that has taken place elsewhere in the business world. We are now dealing with fewer and fewer companies, as mergers, consolidations, and divestitures from major pharmaceutical firms take place. The animal pharmaceutical industry has gotten more competitive. Some of the elements driving this change are financial and scientific.

Recognizing that an unpredictable regulatory environment does not help that situation, we have been trying to make the regulatory process as transparent as possible.

In my opinion, the biggest driver has been the success of the human pharmaceutical industry and the great potential it has shown for generating profits. Major pharmaceutical companies can realize much greater profits by investing the same amount of money in human drugs rather than animal drugs.

Also, profit margins on agricultural commodities are very narrow. In order for a livestock producer to make a decision to use a drug in a large herd of animals, the cost needs to be offset by gains in production.

A positive trend in the industry is the development of new drugs to treat companion animals. As people increasingly treat their pets as members of the family, they are more willing to spend their disposable income on products to improve the welfare of their pets. Companion animal medicine is an exciting area in which we are seeing some new product -development.

CVM successes

What successes have come from the challenges of the past 10-plus years?

When we developed our CVM Strategic Plan, we called it “Back to Basics.” As new issues arose, e.g., international trade, counterterrorism, etc., we were being pulled away from our core functions—pre-market review of animal drugs, post-market surveillance of animal drugs, feed safety, and enforcement and compliance. We needed to refocus our attention on our core functions, and refrain from taking on new issues unless it was absolutely necessary. We still have to deal with crises, such as bovine spongiform encephalopathy, for example, but we are trying to compartmentalize that crisis to the extent possible so it does not affect how we carry out the core functions of CVM. I think we have been successful, as our recent successes with the Animal Drug User Fee Act and the Minor Use and Minor Species Health Act would suggest. We had to rely on the back-to-basics focus in our strategic plan to make these recent successes possible.

Now that you have seen the Center inside and out, how have your views changed?

I must say that after more than 10 years I still believe in the importance of CVM. I always thought CVM was a great organization with a vital mission. The only real change—after working with people in CVM for more than a decade—has been an increase in my respect for the Center and the people who work here. Being a part of CVM has been a wonderful experience. My fundamental attraction to CVM has not changed over the past 10 years—the mission of FDA and CVM.

The mission of FDA—protecting the public—is one to which I am deeply committed. This position allows me to make a meaningful contribution in protecting the public and in dealing with animal health and safety. In addition, the high level of scientific expertise at FDA and the organization’s strong grounding in science made it very attractive for me to leave academia to come to this regulatory agency.

As a veterinarian, I am very interested in making sure the health care needs of animals are met. There are not many places where your work as a veterinarian affects not only individual animals, but all animals. This is very rewarding to me.

Finally, how would you sum up CVM’s progress after more than a decade in the Director’s chair?

My primary goal was to make the organization stronger than it was when I arrived. I think all the Center Directors who preceded me have made improvements. I wanted to continue to improve on that record of progress. When I look at the Center after more than a decade in this role, I see a significantly better organi-zation than 10 years ago. I am very proud of the work that CVM does. It is a privilege to sit in the Director’s seat.