CLSA Report: Tracking FDA Drug Review Performance
The FDA has an important and difficult job: Ensuring timely and efficient drug review processes while maintaining rigorous scientific and safety standards. Overall, agency performance has improved markedly, a reflection of the work by FDA leadership, industry, Congress and other stakeholders. Refinements, such as the most recent user fee legislation (the 2012 FDA Safety and Innovation Act) and the breakthrough therapy mechanism, have accelerated approvals.
Still, there are wide variations across therapeutic areas, with some indications, such as oncology and infectious disease (e.g., Hepatitis C), benefiting more than others. As we approach the next user fee reauthorization and recognize the differences across therapeutic areas, there is a real opportunity to identify managerial, procedural and other practices that will promote more consistency across the agency.
Improved Review Times…
Since 2009, FDA review times have steadily declined.
…With a Caveat
Over the last ~15 years the fastest reviews have been in oncology, infectious and rare diseases (although the gap has significantly narrowed over the last 5 years).
Some Therapeutic Areas Still Need Improvement
Despite consistent decreases in average approval times, endocrine, gastrointestinal and CNS therapies have lagged behind in recent years.
Pharmaceutical and biotechnology innovators seek the breakthrough designation because it provides a faster path to patients. Since its inception, breakthrough therapies have been concentrated in oncology, rare diseases and infectious conditions. That said, 2015 marks an increase in the diversity of breakthrough designated approvals.
The FDA has worked diligently to improve overall drug review times and processes — a success to be applauded. As Congress, the agency and the biopharmaceutical industry look toward the next user fee round, we have a great opportunity to replicate those improvements across all therapeutic areas.