2022-08-25| PolicySpecial

Mounting Criticisms of FDA’s Accelerated Approval Pathway Could Prompt Changes to the System

by Reed Slater
Share To

The FDA instituted its Accelerated Approval Program in 1992 in response to the AIDS epidemic to provide treatment options for life-threatening diseases faster than traditional drug approval pathways. Since then, hundreds of drugs have gone through the expedited pathway, with drug makers vowing to undergo additional clinical trials after approval to confirm the safety and efficacy of the therapies. Despite that promise, many companies put off these studies, called confirmatory trials, for months or years, profiting off drugs that have not proven their efficacy.

Accelerating drug approvals is a double-edged sword. On one side, the process allows patients with few to no other options a chance to receive treatment for life-threatening diseases. On the other hand, the hastened process does not provide enough time for a thorough investigation, bringing drugs to the market that may not actually benefit the patient and, in a worst-case scenario, potentially harm the patient. 

GO Prime with only $1.49 now

Accelerated Bio and Pluristyx Generate Clinical-Grade Induced Pluripotent Stem Cells from Reprogrammed Human Trophoblast Stem Cells
Novo Nordisk and PT Bio Farma Agree to Enhance Insulin Production for Diabetes Patients in Indonesia
Alzheimer’s Drug LEQEMBI Approved for Treatment in Hong Kong
Foreseen Biotech Strikes $1.03B Deal with Ipsen for First-in-Class ADC
Synthetic Biology’s Innovator Dr. John Cumbers – Addressing Inefficiencies in Biopharma and Economic Sustainability
Delivering Affordable Biologic Medicines Worldwide: An Interview with Tanvex Chairman and CEO, Henry Chen
Roche Secures CE Mark for AI-Powered Glucose Monitoring Solution, Enhancing Diabetes Care with Predictive Insights
Scroll to Top