Drugs

Brand, Generic Drug Groups Seek Changes to Approval Pathways Guide

Brand-name and generic drug manufacturers are urging FDA to revise its proposed guidance (see earlier story) on determining whether sponsors should submit an ANDAor a 505(b)(2) application, with the two industry groups emphasizing different concerns about the agency's interpretation of the approval pathways.

In separate just-posted comments on FDA's August draft guidance, the Pharmaceutical Research and Manufacturers of America (PhRMA) called for stricter distinctions between the pathways, while the Association for Accessible Medicines (AAM) urged greater flexibility to facilitate generic drug development and competition.

PhRMA (see comments) generally supported FDA's effort to clarify application requirements but warned that several provisions could blur the statutory distinctions established under the Hatch-Waxman framework.

A central concern involves FDA's discussion of "limited confirmatory studies" that may support ANDA approval. PhRMA said such studies should be narrowly tailored to establish requirements such as active ingredient sameness or bioequivalence, rather than establish a drug's safety or effectiveness, which would require a different approval pathway.

The association also questioned FDA's position that a pending 505(b)(2) application could remain eligible for approval even if FDA subsequently approves a pharmaceutically equivalent product. PhRMA argued that such applications should instead be submitted through the ANDA pathway, citing potential implications for patent certification requirements.

PhRMA further urged FDA to ensure that allowing duplicate and non-duplicate products in a single 505(b)(2) application does not permit sponsors to circumvent ANDA bioequivalence requirements.

AAM, meanwhile, urged FDA (see comments) to broaden the circumstances under which sponsors may use either approval pathway, arguing that a more flexible, science-based approach could reduce development costs and accelerate access to affordable medicines.

One concern involves discontinued reference drugs for which conventional bioequivalence studies cannot be conducted. AAM said FDA should clarify when a 505(b)(2) application would be appropriate if no acceptable alternative method exists to establish bioequivalence.

The association also encouraged FDA to consider additional approaches to demonstrating bioequivalence, including comparisons with reference products sourced from countries with comparable regulatory standards when scientifically justified.

AAM further urged FDA to expand the circumstances in which generic manufacturers may use ANDAs for injectable, ophthalmic and otic drugs containing inactive ingredients that differ from those in the reference product.

The association argued that differences in inactive ingredients do not necessarily affect safety, effectiveness or bioequivalence and that FDA should make broader use of its regulatory waiver authority when sponsors can provide adequate supporting evidence.

AAM said the agency's current approach could unnecessarily push certain products into the more costly 505(b)(2) pathway, potentially discouraging generic competition.

Both associations called for greater regulatory clarity and predictability.

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