Thanks to our friends over at Broken Hartz for Tweeting about this news earlier.
On September 14th, a press release went out stating Perrigo Company planned on acquiring Sergeant’s Pet Care for a cash settlement of $245 million.
In line with almost every other over the counter flea and tick product company, Perrigo Company is a manufacturer of private label OTC pharmaceuticals and focuses on healthcare products, generic prescription drugs, active pharmaceutical ingredients and consumer products. It’s interesting isn’t it? The two enmeshed markets for flea and tick products are the pharmaceutical industry and agricultural pesticide companies.
I was curious about Perrigo and the CEO Joseph C. Papa. Mr. Papa owns a slew of companies, most of which have some variation of Perrigo in them. The FDA investigated his company L. Perrigo of Allegan, Michigan from November 17, 2009 to January 14, 2010 for “significant” violations in the Current Good Manufacturing Practices regulations. Due to their inability to safely make the drugs they sell, the FDA decided their products were caused to be adulterated.
What did the FDA find at L. Perrigo? (Bold is my emphasis added)
1. Your firm failed to reject drug products failing to meet established standards or specifications and any other relevant quality control criteria [21 C.F.R. § 211.165(f)].
For example, your firm failed to reject a lot of lbuprofen Tablets 200 mg (lot 9BE1961) that was contaminated with metal shavings due to an equipment failure. Although your firm segregated a portion of the lot that was affected, you released and shipped a subportion of that segregated lot, resulting in a recall of the entire lot.
2. Your firm failed to thoroughly investigate the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed and extend investigations to other batches of the same drug product and other drug products that may have been associated with the specific failure [21 C.F.R. § 211.192].
For example, your firm did not thoroughly investigate possible foreign tablet contamination in your filling equipment. After finding a brown, round Ibuprofen tablet (lot 8ME1624) in a lot of brown, oval Ibuprofen caplets (lot 8ME1731), you did not inspect the lot of orange, round Ibuprofen tablets (lot 8ME1728) that was packaged between lot 8MEl624 and lot 8ME1731. Without extending your investigation to lot 8MEI728, there is no assurance that this lot was not also contaminated.
It looks like Mr. Papa’s rule of thumb is to snub regulations at the cost of human health. Metal shavings? Really? Who made the decision to release those tablets? And contaminated ibuprofen that no one thought was important enough to look into?
You might think that this man is so far removed from what goes on in his plants that he could not be held personally responsible for the failings of his company. Perhaps. However, as a great boss of mine taught me once when I was very young, “Shit always floats downhill”. What I mean by this is that the CEO hires the people who hires the people and so a culture of misconduct is rarely a middle-management issue. A company creates a culture from the top down, not the other way around.
At some point, this issue is serious enough for Mr. Papa to have at least be read into the issue and potential resolutions available.
The Quality Control department also seems to have some issues. They failed to follow written procedures, and as such allowed mislabeled Milk of Magnesia to be released, and later recalled. Apparently they also can’t be bothered to put the correct values on their product for ingredients.
…verifying the accuracy of label ingredient disclosure quantities of magnesium and calcium in Regular and Mint Flavored Milk of Magnesia and identifying incorrect values as changes from expected label specifications.
Mistakes do happen, but it’s then for responsible companies to fix the issues at hand and put procedures in place so they won’t happen again. Sadly everything in government regulation land takes so very looooooong to get anything done. What does that mean for companies like L. Perrigo? It means they can continue bad behavior, even paying wrist-slap penalties and consider them a “cost of doing business”. This wasn’t the first issue found at this very same plant. (My emphasis added.)
FDA investigators documented your firm’s failure to follow Standard Operating Procedures (SOPs) during the last three FDA inspections, as well as in other inspections since 1998. Although your February 1, 2010 response acknowledges the procedural errors and recalls in both examples above, your response does not provide the corrective actions your firm plans to take to prevent reoccurrences in the future.
According to the FDA, Perrigo has had a long history of “mixups” and has made promises to be good and fix the issues.
Your firm has had an ongoing program since 2005 to address mixups. However, your firm continues to receive complaints regarding this issue, and despite past assurances that previous enhancements would control this problem, deviations continue. Your firm failed to implement sustainable corrective actions to prevent mixups as well as other continuing problems.
What does this have to do with your pet and flea and tick products? Good question. Several times in the history of flea and tick products pets have died at record rates due to packaging being wrong. An example would be a Great Dane dose in a Chihuahua package for weight class. Worse, a dog dose and product in a cat labeled product. Many of the ingredients in dog products are lethal to cats.
There were two other letters from the FDA warning Perrigo Company to clean up it’s act.
This frustrates me. The entire industry and government regulation-that-fails-to-regulate frustrates me. I am angry that companies making human medications can continue to produce to faulty standards for over 15 years and still continue to be in business. If this is how lax the regulations are with human medication, you can image what a hey day Perrigo will have with Sergeant’s. Not only flea and tick products, but also dog toys, animal treats and a slew of thousands of SKUs.
If regulators care so little for you and I, do you think they will care any more about our pets?
I should clarify that over the counter flea and tick products, including many sold at the vet, are regulated as pesticides by the EPA (Environmental Protection Agency). Very few are under FDA purview. However, the dance between profits and protection of health is the same. They write letter, the companies respond, they write more letters, they companies respond. Inspections are few and far in between and are not “surprise” inspections in most cases. This gives the companies who want to pull a fast one, clean up at least some of their act before inspectors arrive. Then more letters go out. Maybe a few off the books meetings. Rarely fines and if the companies are fined then it is so insignificant in the light of the profits made off the back of our health and the health of our pets.
Large corporations have very little incentive to fix issues unless their internal moral compass tells them to.