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Blog & Resources Camargo Blog March 29th, 2015

PhRMA and GPhA Team Up (!) to Offer their EAR Proposal to Solve Generic Safety Labeling Issue

FDA held a public hearing this past Friday (27March2015) to air their proposal that generic companies be responsible for updating their labeling whenever ‘new safety information’* is available. Generic companies argue against such a proposal because it would lead to confusion about safety warnings if every multisource product has different labeling (coincidentally, and privately, they worry about litigation). The GPhA and PhRMA have teamed up to present an alternative proposal called the Expedited Agency Review (EAR). Essentially, EAR tasks the NDA and/or ANDA holder(s) to submit to FDA what they consider new safety information. The FDA would review this information in conjunction with information it may have in its Sentinel System and require changes in labeling if needed.

According to their proposal, EAR “would replace the changes being effected process for safety related labeling changes now permitted under 21 CFR §314.70(c)(6)(iii)“. Although commentators (for example, Tavernice in The NY Times : “The proposal would apply only when both a brand-name drug and its generic counterpart were both on the market.”) have suggested that EAR is limited to those situations where there is both an active NDA and one or more ANDAs, my reading is that would also apply even in the case where of a non-genericized NDA. In fact, EAR appears to be a vehicle to demand an expansion of the Sentinel System: “Active surveillance by the Sentinel System will allow FDA to identify an increased risk of common events that healthcare providers may not suspect are related to medical products. Therefore, public health can be protected more effectively by using the Sentinel System and relying far less on the historical passive reporting processes.” This would appear to place the legal burden of what constitutes the correct safety information to the FDA. Public Citizen’s Dr. Micheal Carome is quoted as saying “[n]o other industry is so shielded from liability risk”.

505(b)(2) advocates should consider making their position known by making a submission to the docket.

* All parties seem to agree that “new safety information” has the definition provided in the Guidance for Industry: Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act, dated July 2013.



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