Size Matters… Even To FDA Reviewers

Size Matters… Even To FDA Reviewers

January 6th, 2012 // 1:14 pm @

Now that we have your attention, we must confess this is not about penile matters. Rather, the issue involves generic tablets and the extent to which these differ in size from brand-name meds. To put it simply, generic tablets that are clearly much larger may pose safety and efficacy problems for patients, according to the FDA Office of Generic Drugs.

Recently, the agency issued letters to several drugmakers with pending abbreviated new drug applications, or ANDAs, for a particular med and wrote that the applications are not approvable. Why? The tablet sizes differ significantly compared to corresponding strengths of the brand-name drug, according to the FDA Law Blog, which has reviewed the letters. The agency has not released these.

One letter reads: “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 brand-name medicine.

However, there appears to be a problem, because the agency has not provided any guidance to the companies about acceptable differences in size. In fact, the letters did not indicate whether this recent decision reflected details specific to this situation or something more sweeping that might apply to difference in size for any number of proposed generics.

“Absent guidance on an acceptable size difference, ANDA sponsors will be stumbling around in a dark room, unable to make informed decisions on how to redesign their products. Such concerns are heightened when there is a patent on the (brand-name medicine) that covers size or shape,” writes Kurt Karst on the FDA Law Blog. He notes this may also raise questions about existing meds.

Whichever direction the agency takes, the issue of difference in size can be legitimate. Of course, this may well mean that generic drugmakers will have to invest more to readily duplicate the physical features of a brand-name med. Size matters in so many ways.

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