FDA has recently issued a series of guidance documents related to prioritizing and classifying significant post market drug safety issues.
FDA has recently issued a series of guidance documents related to prioritizing and classifying significant post market drug safety issues. One document, intended for regulatory professionals, describes the process that FDA will use to categorize adverse drug events as priority, standard, or emergency. This prioritization structure stems from FDA’s tracking of potential signals of a serious risk from its AERS data on a quarterly basis. When a potential signal is identified for a specific drug, the adverse event is entered as a safety issue into CDER’s Document Archiving, Repoorting, and Regulatory Tracking System (DARRTS).
Once entered into DARRTS, a Tracked Safety Issue (TSI) is opened and the sponsor is notified. This process is described in a Manual of Policies and Procedures (MAPP 6700.9) issued by FDA. Currently, there are approximately 1000 TSIs in FDA’s system and according to FDA’s own guidance, “…[w]ithout sufficient resources to manage all TSIs equally, FDA has been prioritizing them on a case-by-case basis, but without an agreed-to-praiority framework.” The new guidance was issued to “…establish a formal framework for prioritizing TSIs so that CDER can direct resources more effectively toward those issues posing the greatest potential risk to patients.”
The methodology described by FDA in the document will address the relative seriousness of the safety issue, the estimated size of the US population exposed to risk of the drug, and the suspected frequency of harm to patients exposed to risk from the drug.
Another guidance, published around the same time, relates to communication of drug safety information to the public.
These FDA programs will be important for both the Plaintiff and the Defense bar moving forward because they reflect an unbiased view as to the seriousness of specific adverse events experienced in relationship to drugs. They also raise the bar in terms of pharmacogivilence and what a Company might have been expected to know about the potential adverse effects of its drugs.
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