Most of Dr. D’s friends know that my significant other rehabilitates wild animals, with the hope of returning injured and orphaned wildlife back into the wild. Before you even have to ask, no, Dr. D is not on the list of animals my wife is licensed to handle and release back into the wild. That doesn’t mean the list might change at some point in the time. That being said, Dr. D came across an article on the FDA’s website citing a recently prosecuted case by the Department of Justice and the affixing of counterfeit labels on devices packaged for use in the veterinary world. Now for my wife and all of her animal rehabilitating friends supporting organizations such as Injured and Orphaned Wildlife (IOW), there can never be a level of Dante’s Hell low enough to punish an individual whose actions result in the potential harming of an animal for profit. For the offending individual mentioned in this week’s guidance, there is no doubt in Dr. D’s mind that all animal lovers in this world will not be writing and sending billet-doux (look-it-up) to this Chief Jailable Officer (CJO) as a federal judge empties his bank account and places him in a cell with his soon to be new-best friend, Mr. Ben Dover. Enjoy!

Department of Justice Press Release – Excerpt

“HOUSTON – A 48-year-old California resident has entered a guilty plea to trafficking in counterfeit labels and packaging, announced Acting U.S. Attorney Abe Martinez.

Paul S. Rodriguez Jr. was the CEO of Action Packing and Design Inc. in Santa Ana, California. Between July 2015 and December 2016, Rodriguez intentionally trafficked in counterfeit labels and packaging by manufacturing, and then shipping to Houston, counterfeit and trademarked Frontline, Frontline Plus and Merial veterinary product labels and packaging. The labels and packaging were originally marketed by Merial – an animal health company located in Duluth, Georgia.

During this same period, Rodriguez also intentionally trafficked in counterfeit trademarked Rimadyl labels, a veterinary product that Zoetis marketed. Zoetis is a health company located in Florham Park, New Jersey.

Sentencing is currently set for Oct. 2, 2017, before U.S. District Judge Nancy F. Atlas, at which time Rodriguez faces up to 10 years in federal prison and a possible $2 million fine. He was permitted to remain on bond pending that hearing.

The Food and Drug Administration-Office of Criminal Investigations and the Immigration and Customs Enforcement’s Homeland Security Investigations conducted the investigation. Assistant U. S. Attorney Daniel C. Rodriguez is prosecuting the case.”

Compliance for Dummies

First off, Dr. D wants to acknowledge the agencies that were involved in this case: (a) Food and Drug Administration-Office of Criminal Investigations and (b) the Immigration and Customs Enforcement’s Homeland Security Investigations. Through their hard-work and diligence they were able to stop an individual from profiteering at the expense of our pets. Badger, Marleau and May-Day (Dr. D’s three dogs) are barking a very loud “thank you” for these agencies. All kidding aside, veterinary devices, although not requiring the same level of control as medical devices, fall under the jurisdiction of the FDA. Now granted, manufacturers of veterinary devices are not required to register as an establishment or submit pre-market approval applications (PMA or 510(k)) with the agency. However, FDA does retain regulatory authority to jump in and correct issues associated with misbranded and/or adulterated devices. Henceforth, the criminal charges brought against the offending CJO mentioned in this week’s guidance.

Additionally, the agency strongly suggests that manufacturers of such devices submit their product labeling for FDA review. It is Dr. D’s unbiased opinion that submitted labeling to the FDA for review would be a splendid idea.

On a lighter note, years ago Dr. D got himself in trouble with his old boss at BSC for creating what was deemed an inappropriate label for a probe used for treating animals. At the time, our distribution center insisted that the device in question required a label. However, after some serious due diligence with my evil-twin, we determined there was no requirement for the device in question. A decision was made to create a label to appease our dear friends in the distribution center. Essentially, we used the infamous Taco Bell Chihuahua supported by the text “Yo Quiero la Probe” (please note, the doctor has redacted the actual name of this device to protect the guilty). Needless to say, our dear VP of RA/QA was not happy and the label was never used. It now hangs on the doctor’s home office wall.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. If a CJO, does some really bad things in pursuit of the almighty dollar, bad things will eventually happen. You can call it Karma, bad juju or payback. Folks, the FDA and DOJ are always watching for opportunities to punish bad apples. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) in the guidance provided. Until the next installment of DG,  cheers from Dr. D., and best wishes for continued professional success.

References

1. Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. Washington, D.C.: U.S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
4. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
5. FDA. (April 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. April 3, 2017: United States Department of Justice Press Release. Accessed April 10, 2017. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm550926.htm