Critical Issues for the CVM Moving Forward

The Alliance for a Stronger FDA is special because we are advocates for the entire agency and our membership include all the stakeholders. Choose almost any Alliance activity or event and you will see representatives of consumers, patients, health professional societies, trade groups, and industry. One of the fun parts of our annual Hill Day is that we mix the teams and participants learn more about FDA from each other, even while they are briefing Hill staff.Every year, we do numerous meetings with the center directors and other senior FDA leaders in order to understand the agency’s resource needs. The last meeting this year -- which was this week -- was with Dr. Steven Solomon, Director of FDA’s Center for Veterinary Medicine (CVM). As I’ve learned in prior meetings, CVM is fascinating -- because its responsibilities cross the entire agency, but also because you have to get up-close to see the many threads that connect CVM to other parts of FDA, other parts of government and to the American people. Said another way: CVM doesn’t get the attention and praise that it deserves.CVM has a 2018-2022 strategic plan that reflects the busy life of the center. When asked what would he do if CVM received an additional 10% over its current funding, Dr. Solomon replied:

I would invest further and more rapidly in what we have defined (in the strategic plan) as CVM’s key initiatives.

He listed seven:

• Pre-market animal drug review
• Food safety
• Antimicrobial resistance strategy
• Emerging technologies and innovation
• Post-market drug safety, effectiveness, and quality,
• Unapproved and compounded animal drugs and
• Outreach to consumers and stakeholders

Dr. Solomon described CVM’s approach to recruitment and vacancies, which is a serious issue for several FDA centers. CVM has about 650 employees, of whom about 50 were hired over the last year to respond to new responsibilities and funding. He indicated that the process went smoothly, reflecting substantial demand for CVM jobs. While that went well, CVM still has troubles with recruiting highly specialized positions, such as IT and biostatistics, because they are also in high demand in the rest of FDA and other public health agencies. In these cases, CVM has developed training programs to, for example, take a biostatistician and teach him/her about how clinical animal studies are planned and conducted in ways that are different from than human trials.One of the difficulties facing CVM and several other centers is that a lot of employees with lengthy tenures are nearing retirement. Dr. Solomon  described CVM’s approach to consolidation of existing knowledge and transferring it to the next generation of leaders. This is a multi-part process that includes succession planning.Over the coming months, I will write more about the parts of FDA that are vitally important, yet mostly out-of-sight of FDA stakeholders. CVM is the largest and best example, but there are many others.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.