Envisioning the Dual Repercussions of FDA’s Accelerated Approval Pathway

1. EnvisioningtheDual RepercussionsofFDA’s AcceleratedApproval Pathway • Clinical trials are comprehensive research studies conducted to ensure that recently developed medical interventions, including novel drugs, surgical & other devices, and treatments/ therapies, are safe and effective for human use before commercialization. These trials provide evidence for regulatory bodies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, UK’s Medicines and Healthcare Products Regulatory Agency, and China’s National Medical Products Administration (NMPA) to ensure that a specific medical intervention is safe for the public use, begets limited adverse effects, and meets quality standards. However, it takes 10 to 15 years or even more to complete all three clinical trial phases before reaching the licensingstage.Thus,FDAintroducedacceleratedorexpediteapprovalstopaceuptheapproval ofdrugsthat treatsevere conditionsandaddressunmetmedicalneeds. • Before proceeding with the pros and cons of the FDA’s expedited program, let’s first understand the full-fledged approval process set by various regulatory agencies to launch any novel medical interventionsinthe marketafter comprehensive analysis. • Pre-Approval: theregulatoryagencies setspecific guidelinesaroundstudydesign, volunteer selection, monitoring procedures, informed consent, and data collection, which pharmaceuticalindustriesmustadheretowhenconductingclinicaltrials. • Investigational New Drug (IND)Application: Drugmakers/ sponsorsareobliged to submit an IND application to the regulatory body before initiating a clinical trial. This application comprises justification, proposed study design, safety data from pre-clinical studies,andafeasible approach tomonitor volunteersduringthe trial. • ReviewProcess: The regulatoryagencythoroughly reviewsthestatisticaldata, data quality, results of all phases of pre-clinical and clinical trials, and potential benefits & risks associatedwith theparticularintervention. • Post-Approval: Even after granting approval for marketing and commercializing medical interventions,theregulatorybodycontinuestomonitorthesafetyandefficacyofapproved products through post-marketing surveillance and requires periodic reporting of adverse events. • NeedforintroducingUSFDA AcceleratedApproval Program • TheUS FDA’sAccelerated ApprovalProgram (AAP)aimstoexpeditethedevelopmentand enable fasteraccess tonewtherapiesthat address anunmetneedintreatingsevere • ailments.Thisprogramismainlyintroducedtopromotethetreatmentof chronicdiseases, where the course ofthe conditionisextended,anddeterminingtheclinicalendpointwould takeconsiderable time.Theprimaryobjective behindintroducing a priorityreviewof • specificdrugsforacceleratedapprovalistolaunchthedrugsearlierinthemarket.To justify, inthe case ofchronicdiseaseslikeHIVandcancer,thoroughlyunderstandingtheeffect of medicationswithprecisioncan take alongtime,whichresults indelayed drugapproval.

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