Envisioning the Dual Repercussions of FDA’s Accelerated Approval Pathway

ByNitin Jindal

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 licensing stage. Thus, FDA introduced accelerated or expedite approvals to pace up the approval of drugs that treat severe conditions and address unmet medical needs.

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 interventions in the market after comprehensive analysis.

  • Pre-Approval: the regulatory agencies set specific guidelines around study design, volunteer selection, monitoring procedures, informed consent, and data collection, which pharmaceutical industries must adhere to when conducting clinical trials.

 

  • Investigational New Drug (IND) Application: Drugmakers/ sponsors are obliged 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, and a feasible approach to monitor volunteers during the trial.

 

  • Review Process: The regulatory agency thoroughly reviews the statistical data, data quality, results of all phases of pre-clinical and clinical trials, and potential benefits & risks associated with the particular intervention.

 

  • Post-Approval: Even after granting approval for marketing and commercializing medical interventions, the regulatory body continues to monitor the safety and efficacy of approved products through post-marketing surveillance and requires periodic reporting of adverse events.

 

Need for introducing USFDA Accelerated Approval Program
The US FDA’s Accelerated Approval Program (AAP) aims to expedite the development and enable faster access to new therapies that address an unmet need in treating severe ailments. This program is mainly introduced to promote the treatment of chronic diseases, where the course of the condition is extended, and determining the clinical endpoint would take considerable time. The primary objective behind introducing a priority review of specific drugs for accelerated approval is to launch the drugs earlier in the market. To justify, in the case of chronic diseases like HIV and cancer, thoroughly understanding the effect of medications with precision can take a long time, which results in delayed drug approval.

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