Vikram Anand on the "Hidden Gatekeeper" Behind Commercial Delays

Manufacturing bottlenecks and logistics snags get most of the attention when the industry talks about why drugs are late to market. But according to Vikram Anand, president, compliance services at EVERSANA, there's a less visible force stalling launches: what he calls the "hidden gatekeeper reality" of regulatory readiness, particularly around pharmacovigilance and safety infrastructure.

In the first installment of this video interview series, Anand points to newly public data on why applications stall, particularly around pharmacovigilance and safety infrastructure. Under the FDA's transparency initiative, the agency has centralized nearly 350 complete response letters (CRLs) in a public database hosted on openFDA, giving the industry an unprecedented look at why applications stall, Anand says.

According to Anand, roughly 37% of applications receive a CRL, and the average time from CRL to eventual approval runs approximately two and a half years. Of those letters, 74% cite quality and manufacturing-related gaps, a pattern Anand says often reflects operational readiness rather than scientific failure. He also flags a transparency gap on the sponsor side: citing FDA findings, he notes that 85% of companies don't disclose to the public why they received a CRL, and roughly 40% don't reveal that the agency has required an additional clinical trial.

For manufacturers preparing to commercialize a biopharma asset, Anand's message is that readiness needs to be defined broadly, extending well beyond the plant floor to encompass the safety and pharmacovigilance functions that regulators are increasingly scrutinizing before approval.