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FDA defends generics labelling proposal Posted 25/04/2014

The US Food and Drug Administration’s (FDA) Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, testified before the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on 1 April 2014, to discuss FDA’s proposed labelling rule for generics.

In November 2013, FDA proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers already do [1]. The new rule would ‘speed the dissemination of new safety information about generic drugs to health professionals and patients’, according to FDA.

FDA sought comments from the public on the proposed rule, and is currently reviewing the comments received. The comment period closed on 13 March 2014.

Although the proposed rule has been welcomed by patient advocacy groups, it has been met with concern from generics groups, with fears that liability cases could drive up the costs of generics. Economic consulting firm Matrix Global Advisors (MGA) has calculated that this change would add US$4 billion to annual healthcare costs in the US [2].

Generics account for 84% of all prescriptions dispensed to American patients [1], and in cases where the originator has stopped production may be the only source of ongoing safety information. Therefore, FDA ‘believes it is time to provide generic drug application holders with the means to update product labelling to reflect data obtained through post-marketing surveillance, even though this will result in temporary labelling differences among products’.

The agency believes that ‘concerns related to temporary differences in labelling between generic drugs and their corresponding brand-name drugs are outweighed by the benefit to the public health’ of generics makers being able to update labelling to reflect new information on safety. Dr Woodcock also pointed out that this already occurs when brand-name drugmakers update their labelling, but generics makers have to wait for FDA approval of the changes before changing their labelling.

In her testimony, Dr Woodcock also specified that in cases where the approval of the brand-name drug application has been withdrawn, FDA’s evaluation of any labelling changes proposed by a generics company would consider any submissions related to the proposed labelling change from other application holders, for the same active ingredient.

In an effort to increase transparency and make safety-related changes to drug labelling readily available to prescribing healthcare providers and the public while the FDA is reviewing a ‘changes being effected’ (CBE-0) supplement, the agency proposes to establish a dedicated web page (or, alternatively, to modify an existing FDA web page) on which FDA would promptly post information regarding the labelling changes proposed in a CBE-0 supplement.

Dr Woodcock concluded by emphasizing that ‘this proposed rule, if finalized, is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.’

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1.   GaBI Online - Generics and Biosimilars Initiative. FDA to allow generics makers to change labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Policies-Legislation/FDA-to-allow-generics-makers-to-change-labelling

2.   GaBI Online - Generics and Biosimilars Initiative. FDA’s labelling proposal will increase cost of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 25]. Available from: www.gabionline.net/Reports/FDA-s-labelling-proposal-will-increase-cost-of-generics

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Source: FDA

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