Two national agencies representing manufacturers and distributors of generics and biopharmaceuticals in the US are calling on the US Food and Drug Administration (FDA) to re-write its proposed rule on medicines safety labelling.
Regulation on patient labelling should maximize patient safety and minimize the chance for any confusion about safety warnings, urge the Generic Pharmaceutical Association (GPhA) and the Pharmaceutical Research and Manufacturers of America (PhRMA): ‘Especially for medicines that are marketed simultaneously as innovator and/or one or more generic versions (multisource drugs)’.
FDA’s proposed rule in this area would allow generics manufacturers to update label safety information independently [1]. Generics manufacturers fear that this would increase their liability in lawsuits that alleged failure to warn of potential drug dangers [2], which in turn would send generic drug prices skyrocketing [3].
In the agency’s defense, FDA Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, told the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on 1 April 2014, that the proposed rule was intended ‘to improve the communication of important drug safety information about generic drugs to both prescribers and patients’ [2].
One year on, GPhA has joined forces with the PhRMA to offer an alternative to FDA’s proposed rule on safety labelling (Docket No. FDA-2013-N-0500). The two associations have written to FDA, saying their solution will ‘meet all of our shared public health goals regarding multisource drugs – the Expedited Agency Review (EAR)’. EAR proposal is consistent with comments that GPhA and PhRMA have submitted to FDA in the docket.
According to their solution, labelling changes would be based on data from FDA’s Sentinel drug safety surveillance system. FDA would oversee any updates to safety warnings.
In February 2015, FDA announced that it would carry out a public meeting on 27 March 2015 and re-open the comment period on its proposed rule allowing generics makers to change their labelling [4].
GPhA and PhRMA have requested a meeting with FDA and their key Leadership Team members to present a detailed account of the proposal and explain how FDA and stakeholders can work together to improve the labelling change notification and review process when new safety information becomes available.
‘These procedures will help ensure that patients and healthcare professionals receive accurate and timely change notification,’ write Mr Ralph Neas, President and CEO of GPhA and Mr John Castellani, President and CEO of PhRMA.
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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 Mar 27]. Available from: www.gabionline.net/Policies-Legislation/FDA-to-allow-generics-makers-to-change-labelling
2. GaBI Online - Generics and Biosimilars Initiative. FDA defends generics labelling proposal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from: www.gabionline.net/Generics/General/FDA-defends-generics-labelling-proposal%20
3. 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 Mar 27]. Available from: www.gabionline.net/Reports/FDA-s-labelling-proposal-will-increase-cost-of-generics
4. GaBI Online - Generics and Biosimilars Initiative. FDA re-opens comment period on generics labelling rule [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from: www.gabionline.net/Policies-Legislation/FDA-re-opens-comment-period-on-generics-labelling-rule
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