Size Matters: New Guidance from FDA Governs Size and Shape of Generic Drugs

On December 9, 2013, the Food and Drug Administration (FDA) released a draft guidance recommending that the size, shape, and physical attributes of generic drugs be of a similar size to the corresponding Reference Listed Drugs (RLD) . Citing concerns over “patient compliance and acceptability of medication regimens,” the FDA has sought to limit variations in the size and shape of generic tablets and capsules.

In its guidance, the FDA noted that it is estimated that over 16 million people in the United States have some difficulty swallowing (a.k.a. dysphagia).   One of the primary reasons for standardizing certain physical characteristics of generic tablets and capsules is to combat problems with ingestion such as pain, gagging, choking, aspiration, and disintegration of the product during esophageal transit. As justification, the FDA cited various studies indicating both that tablets greater than 8mm in diameter provoke increased swallowing-related complaints from patients and that oval tablets may be easier to swallow and have faster esophageal transit times than flat or round tablets of similar weights.

Other reasons to standardize size and shape include patient adherence to medicinal regimens. Unsurprisingly, patients are more likely to stray from their prescribed regimens as complications with swallowing increase. The FDA also acknowledged that characteristics beyond size and shape should be considered (such as tablet coating, weight, surface area, etc.), but declined to address them in its draft guidance. Hopefully, standardizing sizes and shapes to ease swallowing will encourage greater adherence to prescribed regimens.

Of particular concern to generic manufacturers going forward are potential trade dress issues given the FDA’s push for standardization. Trade dress strategies such as the licensing of trade dress take on increased importance as manufacturers of RLDs seek methods to retain market share following the expiration of their market exclusivity.  As trade dress considerations are not addressed during the Abbreviated New Drug Application (ANDA) process, generic manufacturers must be mindful that their adherence to FDA guidance does not expose them to future trade dress claims from RLD manufacturers.