Vikram Anand on PV Infrastructure Gaps

In the first installment of this video interview series, Vikram Anand, president, compliance services at EVERSANA, laid out the FDA data behind the industry's "hidden gatekeeper reality," showing how pharmacovigilance and operational readiness gaps, not just manufacturing issues, are driving complete response letters. In part two, Anand goes further, explaining how those PV infrastructure gaps translate into concrete commercial delays once a drug clears approval.

His central point is that commercialization depends on tightly integrated systems, spanning safety, medical information and quality management, that all need to interact with each other. When they don't, people end up manually bridging the gaps, and that's precisely where FDA's pre-approval inspections tend to find trouble. Anand notes that many first-time launchers offset PV infrastructure gaps by partnering with outside providers.

According to Anand, PV gaps aren't usually a major blocker at the time of approval. The real trouble starts afterward, when commercial-scale adverse event volumes hit systems that were only built to handle clinical-trial-level safety data. Add manual processes, like staff downloading emails and pushing data between systems by hand, and the result is delayed expedited reports, inspection findings, and in the worst cases, restricted commercial access as FDA continues monitoring how a company processes and reports safety data post-approval.

Anand frames it as the same root cause identified in part one, just showing up at a different point in the timeline: operational readiness gets pushed downstream, and the resulting failures surface twice, once before approval and again immediately after.

Watch the first installment of Anand's interview with PC:

1. Vikram Anand on the "Hidden Gatekeeper" Behind Commercial Delays