GENE ONLINE|News &
Mounting Criticisms of FDA’s Accelerated Approval Pathway Could Prompt Changes to the System
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.