Responding to a follow-up request for data TCR has been requesting from the U.S. Food and Dug Aministration since January 2022, FDA spokesperson Anne Norris said in an email with the Center for Veterinary Medicine Director Dr. Steven Solomon copied, “Yes, can confirm receipt. Will round back with you when we have a response.”
In a prior email, TCR advised intent to follow up on our inquiry earlier this year as it had been over six months and more than two years had now passed without an update from the Agency:
I did also want to follow up on my inquiry earlier this year since it’s been more than six months and there is now more than two years of data missing from the public domain since the last time FDA updated it.
Would it be possible to get a more current number of case reports FDA has received of confirmed, diagnosed dilated cardiomyopathy in dogs since July 31, 2020?
Here is the information now running on your website, which now dated by more than two years. I am simply asking for current numbers.
How many cases have been reported to the FDA?
Between January 1, 2014 and July 31, 2020, the FDA received more than 1100 case reports of diagnosed dilated cardiomyopathy in dogs. The majority of these cases were reported immediately after FDA provided public updates. Some of these cases involved more than one animal from the same household. In the reported cases, more than 280 of those dogs were reported to have died. Of the approximately 20 cat reports, there were approximately 13 cat deaths. The agency received additional reports of other types of cardiac disease in dogs, however, these reports did not meet our case definition requirement of a confirmed DCM diagnosis.
Could you please suggest how I might go about that? Happy to speak on background.