FDA’s Top-Four Tablet Scoring Concerns To Get Advisory Committee Review
This article was originally published in The Pink Sheet Daily
Executive Summary
The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will vote on some aspects of FDA’s draft scoring guidance, potentially giving generic industry a clue of future agency actions.
The generic industry should have a better indication Aug. 9 of where FDA stands and could go on the subject of tablet scoring.
Members of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will consider a number of potential tablet coring requirements during the morning session that are part of a draft guidance issued in August 2011.
The requirements, included in four voting questions, appear to be among the most pressing issues the agency is considering as it determines whether to make changes if and when it issues a final scoring guidance.
FDA plans to present its current thinking about the scoring issue, including statistical considerations for scoring testing and an overview of the existing guidance, and ask the committee for its opinion on future directions.
The committee will vote on whether to recommend:
- Evaluation criteria for scored tablets include splitting by patients
- 90-day stability data be evaluated for split tablet sections
- Friability – the tablet’s ability to be split easily – and loss-of-mass criteria be set for split sections
The fourth question will ask if existing products not meeting functionality criteria should have their scoring removed, whether “criteria and labeling” should be written for products that have a “non-functional” score, and whether FDA should “remain silent” regarding scored products that are already-approved.
The committee’s opinion could help determine whether the draft guidance will change when it is finalized and the extent generic sponsors will have to deal with the increasingly contentious issue.
Scoring has become another potential method for a brand company to block generic competition. FDA’s draft guidance seemed to invite citizen petitions from brands arguing a generic should have to follow its scoring convention to be approved (Also see "FDA Takes Its Tablet-Scoring Guidance To An Advisory Committee" - Pink Sheet, 13 Jul, 2012.).
The guidance said a generic product’s scoring should be the same as the reference product, but does not address scoring equivalence. FDA issued the document after its research indicated tablet splitting could affect stability and result in content variations (Also see "FDA Tablet Scoring Guidance Advises Testing Patient Ability To Split Pills" - Pink Sheet, 5 Sep, 2011.).
USP To Give Its Opinion
The [US Pharmacopeia] also will present its opinion on tablet scoring during the committee meeting, including an overview of a proposed USP general chapter. It is considering establishing criteria for products with functional scoring, according to FDA briefing documents.
A 2009 article from USP’s journal Pharmacopeial Forum recommended the organization adopt the standards imposed by the European Pharmacopeia and apply them to all scored tablets to “ensure adequate content uniformity.”
The article’s authors also suggested scoring testing should be done during the development and registration process, not on a batch-to-batch basis.
The tablet scoring discussion is half of the agenda during the final day of the advisory committee’s two-day meeting. Members will receive an update on FDA’s nanotechnology activities during the afternoon session Aug. 9.
The agency will look at in vitro dissolution testing during the first day of the meeting (Also see "Dissolution Tests As A Drug Development Tool: Concept Gets FDA Panel Review" - Pink Sheet, 6 Aug, 2012.).