Concerned that differences between the physical characteristics of generic drugs and their reference listed drugs (RLDs) could affect patient outcomes, FDA has issued a draft guidance for industry on the topic. Today’s Federal Register includes a notice announcing the availability of the guidance document, Size, Shape and Other Physical Attributes of Generic Tablets and Capsules, and the opening of a 90-day public comment period. FDA believes differences in characteristics such as product size, shape, weight, coating, surface area and disintegration time may affect patient compliance, the acceptability of medication regimes, and product performance, and could lead to medication errors. For that reason, the draft guidance recommends that manufacturers of generic drugs consider physical attributes in developing quality target product profiles for their products, and provides suggested limits of variation from an RLD, as well as absolute maximums of some characteristics.
The draft guidance would apply to ANDAs and ANDA supplements for additional strengths. Unless there are safety issues, approved generic products would not be expected to change their characteristics to conform to the draft guidance, or to match changes in the RLD.
Comments are due by March 10, 2014, although FDA regulations permit comments on guidances to be submitted at any time. Manufacturers may want to comment on the appropriateness of the identified characteristics (perhaps there are others that FDA missed) or of the amount of variation presented as presumptively acceptable.
The author thanks Katelyn Ruiz for her assistance.