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GPhA Challenges FDA Final Guidance on Pill Shape, Size

Drugmakers are challenging the legality of FDA final guidance, calling for the design of generic tablets and capsules to be similar in size and shape to the reference drug to ensure patient acceptance.

In a letter posted Sept. 11 on, GPhA claims that requirements related to the physical characteristics of generic drugs — unless related to a scientifically supported safety or efficacy concern — exceeds the FDA’s statutory mandate.

GPhA says the FDA’s parameters for how much a generic may vary from its brand counterpart aren’t necessary since standards for bioequivalence and labeling consistency have already been met.

According to the guidance, for tablets smaller than 17 mm, the generic should be no more than 20 percent larger in any single dimension or more than 40 percent larger in overall volume. For tablets equal to or larger than 17 mm, the generic should be no larger in volume or any single dimension (Generic Line, June 24).

GPhA maintains, however, that patent protections could force a generic manufacturer to develop a dosage unit that doesn’t fit the FDA’s parameters in order to make a lower cost product available to consumers. Under the guidance, NDA sponsors would have even greater incentives to design drugs that would not allow generic manufacturers to meet the size and shape requirements, the group says.

The FDA offers no clarity or justification as to what would adequately justify a size increase, GPhA says. Further, the guidance gives manufacturers little opportunity to resolve questions in a timely manner and no mechanism to obtain additional clarification.

Read GPhA’s letter at — John Bechtel




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