On 8 November 2013 the US Food and Drug Administration (FDA) announced that it had published its proposed rule allowing generics makers to change their labelling in the Federal Register.
The new rule intends to speed the dissemination of new safety information about generics to healthcare professionals and patients by allowing generics makers to use the same process as brand-name drug manufacturers to update safety information in the product labelling.
Generics account for over 80% of prescription drugs dispensed to American patients. But under current regulations generics manufacturers cannot update the labelling of their products until the brand-name manufacturer does so. They can only provide supporting information to FDA, which then determines whether safety information for both the brand-name and generic drugs should be revised before updates can occur.
The new rule being proposed by FDA would allow generics manufacturers to independently update and promptly distribute revised product labelling – in the same way as brand-name manufacturers already do – before FDA reviews or approves the change. Generics manufacturers would also be required to inform the brand-name manufacturer about the change so that they could also consider the information provided by the generics manufacturer as part of its review and evaluation of adverse drug experience information for its drug.
The proposed rule has been welcomed by patient advocacy groups, but has been met with concern from generics groups. Patient Advocacy group Public Citizen, which has been petitioning FDA on generics labelling, was pleased with the FDA announcement, saying that ‘the rule will provide added protection to the tens of millions of people who regularly use generic drugs’. The Generic Pharmaceutical Association (GPhA), which represents generics manufacturers in the US, on the other hand, said that it ‘is very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other healthcare professionals, with harmful consequences for patients.’
The proposed rule could also open up generics companies to liability over product labelling. They had previously been protected from such claims by US Supreme Court rulings made in 2011 and 2013. These stated that generics makers were pre-empted by federal law from being sued for failing to provide adequate label warnings about potential side effects [1] and that generics makers could not be sued by patients for injuries, due to the fact that generics manufacturers either need FDA to order a label change or the brand-name manufacturer to do it first [2].
To enhance transparency while FDA is reviewing any changes, and to make safety-related changes to drug labelling quickly available to healthcare professionals and the public, FDA plans to create a web page where safety-related changes proposed by all drug manufacturers would be posted. Members of the public would also be able to subscribe to the web page to receive updates.
FDA is seeking public comment on the proposed rule, which should be submitted to FDA by 13 January 2014.
Related articles
Brand-name and generics labels don’t match
Generic pre-emption raises its ugly head again
References
1. GaBI Online - Generics and Biosimilars Initiative. Generics manufacturers do not have to change drug safety labels in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 22]. Available from: www.gabionline.net/Generics/News/Generics-manufacturers-do-not-have-to-change-drug-safety-labels-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Generics may be allowed to change drug labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 22]. Available from: www.gabionline.net/Policies-Legislation/Generics-may-be-allowed-to-change-drug-labelling
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Source: FDA, FDA Voice, Federal Register,GPhA, Public Citizen
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