FDA re-opens comment period on generics labelling rule

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FDA re-opens comment period on generics labelling rule

INICIO/Políticas y legislación | Posted 27/02/2015 0 Post your comment

In a Federal Register notice published on 18 February 2014 the US Food and Drug Administration (FDA) announced that it will carry out a public meeting and re-open the comment period on its proposed rule allowing generics makers to change their labelling.

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

However, generics companies have strongly opposed the rule, saying that it could open them up to billions of dollars in annual legal liabilities and increased pharmacovigilance monitoring costs. In fact, an analysis by economic consulting firm Matrix Global Advisors (MGA) has shown that this change would add US$4 billion to the annual healthcare costs in the US [2].

The original time period for the changes to generics labelling were expected to come into force in December 2014. However, the agency received more than 100 comments in the original comment period, which closed on 13 March 2014.

In this new announcement FDA said it would hold a 1-day public meeting to provide a public forum for FDA to listen to comments on the proposed rule and alternatives offered to this proposed rule. The agency will also re-open the comment period for the proposed rule to allow submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.

The meeting will be held on 27 March 2015 at FDA’s White Oak Campus, Silver Spring, Maryland. Individuals wishing to attend the public meeting must register for the meeting by email to CBESupplements.PublicMeeting@fda.hhs.gov by 16 March 2015.

Comments and suggestions regarding the generics labelling rule can be submitted to www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments and suggestions should be submitted by 27 April 2015.

FDA defends generics labelling proposal

References
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 2015 Feb 27]. 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 2015 Feb 27]. Available from: www.gabionline.net/Reports/FDA-s-labelling-proposal-will-increase-cost-of-generics

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Source: FDA, Federal Register