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U.S. Department of Health and Human Services

Animal & Veterinary

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Dr. Dunham Stresses Importance of Communications for CVM

by Vashti Klein, Management Analyst, Communications Staff
FDA Veterinarian Newsletter 2007 Volume XXII, No IV

Dr. Bernadette Dunham, who was appointed Deputy Director of the Food and Drug Administration’s Center for Veterinary Medicine earlier this year, and who became Director of CVM’s Office of Minor Use Minor Species in 2006, brings to those posts strong ideas about the importance of communications to government, regulated industry, associations, and the public in general. Recently, FDA Veterinarian interviewed Dr. Dunham to find out more about her communications goals.

What are your communications goals for CVM?

CVM’s mission of protecting public and animal health through the approval of safe and effective drugs is critical, and the more stakeholders understand our mission, the better we can work together. Educating stakeholders about the complexities of FDA/CVM’s regulatory process is vitally important to good communications. This includes explaining complex processes like the intricacies of the pre-market review process, the importance of post-market surveillance, and the role that research plays. These processes require working closely together to protect the public health.

You have had significant experience outside and inside CVM. From that experience, can you identify the aspects of what CVM does that most stakeholders may not realize or fully understand?

Pharmaceutical companies know a great deal about us, but there is still a lot that they do not know. Something the regulated industry may not be aware of is the exciting research that is conducted at our facilities in Laurel. (CVM’s Office of Research is in Laurel, MD.)

Stakeholders do not always realize how well people at CVM stay abreast of cutting-edge technologies and advances in the biomedical sciences through seminars and lectures, as well as through the courses offered by the CVM Staff College, which now includes a program to obtain a Master’s degree in Public Health.

I want our stakeholders to know that we value their perspectives and that we strive to resolve issues of concern in an efficient manner. Three years ago, FDA launched the Critical Path Initiative: FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. Since the initial report in March 2004, the Critical Path Initiative has been broadened to include veterinary medicine, generic drugs, and foods. (See the article, “Need for Veterinarians in Biomedical Research,” which discusses more about the Critical Path Initiative, elsewhere in this edition.)

The more we all understand the challenges facing animal drug development or can set up collaborations to identify areas ready for improvement (as part of the Critical Path Initiative), the easier it will be to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of developing and evaluating FDA-regulated products. We need to foster strong and sustained scientific advances that will enhance the health of animals and protect public health.

What are your views on internal communications at CVM?

Communication is quintessential no matter where one works. At CVM, the more people are aware of the issues confronting various offices, understand what is expected of them, freely exchange ideas and solutions, and sustain transparency, then the more cohesive the entire CVM team becomes and the easier it is to embrace change and meet the challenges of the future. People take pride in their organization and feel a genuine part of the organization the more they understand the issues, the applicable regulations, our customers, and our overall goals.

Feeling left out or feeling unappreciated often results when communications break down. Communicating often, honestly, and respectfully can resolve most workplace tensions. Encouraging tolerance of people who are different from us and taking time to get to know others can diffuse daily tensions. Resolving differences quickly and moving on—these are small steps that have large results.

When various offices in CVM understand what other offices are doing and there is a free exchange of ideas and solutions, the more cohesive the entire CVM team becomes in the performance of our jobs.

Keeping morale high is an important part of an organization’s work culture. In doing so, it is very important to show people that they are appreciated and to acknowledge the strengths and attributes that each person brings to the table. Moreover, people will seek a positive work environment where everyone treats one another with respect, honesty, and integrity.

How can we communicate better with the public?

CVM’s external communications can be enhanced. One needs to be proactive and to quickly put out messages of importance using various multimedia resources: Internet, pod casts, radio, television, newspapers, national and trade magazines. And creative ways must be found to reach out to today’s generation so that they will tune in, listen, and engage in discussions with us.

It is easy for people to misunderstand the complex scientific issues of the day, especially if those issues are reduced to short sound-bites. We have to improve how we explain complex scientific problems to a public that may not have a science background. Moreover, public perception is often not based on scientific fact, and emotions often come into play, further complicating the communication between groups. Collaboration and outreach with various professional groups, academia, associations, and industry is an important way to help convey the facts surrounding a specific issue to the public, and to enhance the public’s understanding.

What else should CVM do?

It can be as easy as speaking with your next door neighbor and letting him or her know what CVM is all about…many people do not know that drugs for animals go through an FDA approval process similar to that for human drugs. Taking a moment to explain this can help improve the public’s understanding of how CVM is supporting and protecting them. Embracing opportunities to address students in public schools and universities helps highlight the multitude of careers within CVM while simultaneously explaining what we do to protect public health and animal health.

What problems will better communications address?

Through clear communication and transparency, CVM can, for example, help industry meet the regulatory requirements for animal drug approvals. Pre-submission conferences have greatly enhanced the understanding of what is expected when a sponsor is embarking on the drug approval pathway and helps avoid misinterpretations. This, in turn, impacts the quality of submission and hopefully leads to a one cycle review (meaning that a drug sponsor will fully understand the data requirements of an application before it is submitted, so the sponsor will not need to submit it multiple times), which is a goal we all embrace.

The more the public understands and is continually educated about the overall mission of CVM, the more we can be successful in protecting the public health.

And the better we communicate internally, the better able we are to accomplish this.

Communications on anything can always be improved!