FDA/Industry Revolving Door could affect Pet Owners

From FDA to Elanco animal drug director to director at FDA Center for Veterinary Medicine Office of Surveillance and Compliance. Pet Owners now face potential complications with the FDA ‘Revolving Door’.

The FDA announced yesterday – 2/27/19 – that “Timothy Schell, Ph.D., has returned to the agency’s Center for Veterinary Medicine to lead its Office of Surveillance and Compliance. Dr. Schell rejoined the agency on February 17, 2019.”

Dr. Schell “rejoined” FDA after leaving the agency in 2014; “Dr. Schell joined Elanco Animal Health to lead regulatory affairs strategies in several different areas, expanding the firm’s global initiatives in animal drugs and feed additives.”

“Dr. Schell previously served with CVM for fourteen years, joining the center in 2000 as a reviewer of new animal drugs for swine and poultry.”

Dr. Schell takes over the position of director of FDA Center for Veterinary Medicine Office of Surveillance and Compliance which was previously held by Dr. Dan McChesney. Though certainly we didn’t always agree on issues, Dr. McChesney was always willing to talk with us (consumer representatives). That FDA transparency disappeared when Dr. McChesney retired a little less than a year ago (May 2018).

Time will tell if Dr. Schell will be as open and willing to discuss pet owner concerns as Dr. McChesney was. The following email was sent to Dr. Schell today (2/28/19) to introduce ourselves:

Hello Dr. Schell,

I wanted to take this opportunity to introduce myself and who I represent as I don’t believe we have previously met.

I’m Susan Thixton, pet food consumer advocate – representing pet owners, the largest stakeholder organization of any CVM regulated product. Dr. McChesney was a gracious Director of CVM OSC – meeting with pet owners, and speaking with consumer advocates many times over the years. Needless to say, we did not always agree on issues – but he was always willing to listen to our concerns.

This openness and equitable treatment of consumer stakeholder representatives completely disappeared after Dr. McChesney retired from the agency. We have requested a public meeting (asking for potential dates) of CVM representatives and pet owners months ago. While FDA has provided multiple person to person updates and Q&A opportunities to industry, the agency has never provided the same to pet owners. Our request for a pet owner public meeting has been ignored.

We reached out to acting directors of CVM OSC hoping to provide pet owner assistance to the agency’s current diet-related DCM investigation. We were completely ignored. Instead, FDA chose to work ONLY with industry.

Association for Truth in Pet Food, our official stakeholder organization, submitted a Citizen Petition to FDA in October 2016, with an addendum added in June 2017 (after a meeting with Dr. McChesney and team). To date, we have not received a response to our Citizen Petition.

You worked at CVM during the darkest moment of pet food history, the 2007 pet food recall. After this deadly event, Congress wrote the Food and Drug Administration Amendments Act which included Section 1002 (a) Ensuring the Safety of Pet Food. Pet owners were promised improved pet food ingredient definitions and ingredient standards, updated processing standards, and updated pet food labeling that include nutritional and ingredient information. Though Congress required FDA to complete this work by September 2009, the agency never completed the requirements of FDAAA Section 1002 (a) providing pet owners with necessary pet food safety updates. Last year, an addendum submitted to an unrelated bill completely deleted these pet food safety requirements in their entirety.

From pentobarbital after pentobarbital recall to excess Vitamin D after excess Vitamin D recall – the current conditions in pet food are a dangerous, reckless mess. Existing conditions of pet food are no different than they were in 2007 – at any moment, another deadly disaster could happen. This must change.

We are a determined group of pet owners that want nothing more than safe and healthy pet foods for our furry families (truly safe and truly healthy, not just marketed as such). We hope your leadership will be one willing to work with ALL stakeholder organizations, not just industry. We look forward to meeting you and working together to assure pet food law is abided by, and pet foods are safe and healthy for our important family members.

Sincerely,

Susan Thixton

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
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