By Eric Foxman, AAHP Secretary
Once upon a time, a special creature, the CIAMP (Company Interested in Alternative Medical Products), wanted Phoxman Farmaceuticals (PhoxFarm) to contract manufacture a product for it. Over cheesecake and ice cream, they discussed the project and agreed to do business together.
The CIAMP created the formula, designed the labeling and gave both to PhoxFarm for production and packaging. PhoxFarm agreed to make the product as formulated but gave feedback to the CIAMP that the labeling did not comply with HPUS and CFR requirements, and even made suggestions for changes the CIAMP should incorporate to bring the label into compliance. The CIAMP received the suggestions but would make no changes to the labeling. PhoxFarm then proceeded to make and package the product as designed by the CIAMP.
Eventually, the dreaded PoThaBe (the POwers THAt BE, known in some versions of this tale as the U.S. FDA), saw the noncompliant labeling and told the CIAMP to cease and desist as the product was woefully “misbranded according to the meaning of the Act” and threatened sanctions against the CIAMP, including possible jail time.
But the story doesn’t end here. Oh, no, no, no! For the dreaded PoThaBe also knew that PhoxFarm had been the contract manufacturer for the product. The PoThaBe could also have let PhoxFarm know that the Act considers PhoxFarm to be responsible for any and all products it makes, whether under contract for others or not. PhoxFarm might have claimed that its contract with the CIAMP clearly stated that the CIAMP was 100% responsible for label content, and therefore PhoxFarm should be absolved of all liability for noncompliance. But the PoThaBe would have insisted that such a contract doesn’t change PhoxFarm’s legal culpability. And, not only in stories but in real life, too, the PoThaBe would have had the force of the law to back it.
However this tale doesn’t go down that path, even though it could have. In this story, the PoThaBe directed PhoxFarm’s attention to a literary thriller entitled Contract Manufacturing Arrangements for Drugs: Quality Agreements, in which the protagonist plots a path for good compliance. However, the CIAMP did go to jail because of the violations. PhoxFarm, of course, was under no obligation to visit the incarcerated. Yet, because we like stories to have some kind of happy ending, PhoxFarm at least had cheesecake and ice cream delivered to the federal facility.
But the cheesecake and ice cream are not the moral of the story.
Rather, the tale is told to remind us: contract manufacturers are responsible for whatever goes out their doors. They need to make the products as if their own name was on the label. Because, in the eyes of the law, it is.