Fill Me Up Buttercup
|Today’s lesson is on a Big Pharma term that may be new to my readers. “Overfill” is the extra drug quantity, over and above the labeled dose, in FDA-approved containers. This is a standard manufacturer’s practice to ensure that clinicians who administer the drug will always be assured the full labeled dose can be extracted. It’s a patient quality assurance control, and overfill is NOT included in the vial price.
A recent article by Jonathan Stempel from Reuters explained how a unit of AmerisourceBergen Corp, a large drug wholesaler, agreed to pay a Department of Justice settlement fine of $625 million relating in part to overfill fraud.
The scheme worked when the drug product was removed from the original FDA-approved glass vials. Then the medication was pooled into untested and unapproved plastic containers. Finally, the drug (which included the overfill) was extracted and repackaged into syringes. Over a million unapproved syringes per year were manufactured, and Big Pharma’s profit was overfilled by $100 million.
The FDA did not take kindly to this process, which they believed risked the safety and efficacy of these medications, and placed greed over the protection of vulnerable patients.
Big Pharma never ceases to amaze.
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Posted in OMCA