Did you ever wonder what the FDA’s approval and review process is for a pet drug? I did.
Since the time of the Great Melamine Pet Food Recall of 2007, pet owners have been painfully alert to new recalls and warnings issued by the FDA, and there have been many (I just posted another one today on our Daily Paws blog, the second one in a week).
While I was researching a recent article on an FDA issued warning for flea and tick products, I came across this page on their website:
Transcript for the March 24, 2010 Veterinary Medicine Advisory Committee from March 24th, 2010, and this transcript deals with the pet product ProHeart 6, a canine heartworm preventative.
It is a fascinating and revealing look at the process that the FDA takes after it has received complaints about a particular drug or pet food on the market.
The FDA develops a RiskMAP (Risk Minimization Plans, which is a process of assessing a product’s benefit to risk balance, developing and implementing tools to minimize its risks while preserving its benefits, evaluating tool effectiveness and reassessing the benefit-risk balance, and making adjustments as appropriate to the risk minimization tools to further improve the benefit-risk balance), for a drug and this is one of the terms that you’ll see when you visit the link above so it is good to have a grasp of what they are talking about.
If you google ProHeart 6, you’ll see that it is a product that has been controversial, both with pet owners and with some veterinarians. I visited www.proheart6.com today and – while the site isn’t working quite right – I saw what I think the is RiskMAP for this product there.
It is well worth your time to peruse these transcripts. See what a typical product evaluation process is and just how the FDA treats all those reports of adverse results a drug has on our pets.
It’s good to know.