'Size Matters,' says FDA, when it comes to generic drug-RLD sameness

In what appears to be a further sign of the US Food and Drug Administration’s efforts to clamp down on differences between brand-name Reference Listed Drugs (RLDs) and their proposed generic counterparts, the FDA’s Office of Generic Drugs (OGD) is now looking more closely at tablet size differences. The increased scrutiny may be intended to address, at least in part, criticism about some generic drugs not acting the same as their brand-name counterparts, notes Kurt Karst, writing on law firm Hyman, Phelps & McNamara’s FDA Law Blog.

He notes that the OGD recently issued letters to companies with pending Abbreviated New Drug Applications for one product, stating that the applications are not approvable because of tablet size differences when compared to the corresponding strengths of the RLD. According to the letters:

The larger tablet size poses greater potential safety issues such as choking, tablet arrest and prolonged transit time, which could result in esophageal injury and/or pain. The larger tablet size also raises product efficacy concerns due to patients’ inability or unwillingness to swallow the larger tablets…Therefore, from a clinical standpoint, this product is unacceptable for approval as a generic and we recommend that you redesign your product to be closer in size to the relevant strengths of the RLD.