FDA: DSCSA enforcement update

The FDA issued an enforcement policy update for the Drug Supply Chain Security Act, extending the compliance timeline for certain interoperable traceability requirements for wholesale distributors. While primarily a supply chain regulation, the safety implications are direct: traceability is the mechanism by which counterfeit, diverted, or recalled products are identified and removed from distribution.

What this means for practice: Pharmaceutical companies should review their serialization and traceability infrastructure against the updated timeline. Pharmacovigilance teams should ensure that product tracing capabilities support rapid recall execution.

EMA PRAC: PCSK9 inhibitor neurocognitive signal

The PRAC initiated a formal signal evaluation for the PCSK9 inhibitor class — evolocumab and alirocumab — following a cumulative review of spontaneous reports of neurocognitive adverse events including memory impairment, confusion, and attention disorders. The signal was identified through routine EudraVigilance disproportionality screening.

The evaluation will consider data from the FOURIER and ODYSSEY OUTCOMES cardiovascular outcome trials, both of which included pre-specified neurocognitive assessments, as well as post-marketing surveillance data.

What this means for practice: No prescribing changes at this stage. The PRAC evaluation is expected to conclude within two signal assessment cycles.

Health Canada: SGLT2 inhibitor labeling

Health Canada updated the product monographs for all marketed SGLT2 inhibitors to include strengthened warnings about the risk of Fournier gangrene (necrotizing fasciitis of the perineum). The update incorporates Canadian post-marketing data showing 14 confirmed cases since the class was first marketed in Canada, with 3 requiring surgical intervention.