Industry Official Warns Trial Transparency Push Could Delay EU Drug Applications

If EU regulators and pharma cannot agree on how to handle publication of clinical trial data, drugmakers may delay filing applications in the EU to preserve exclusivity, a Pfizer official says. Speaking during a PhRMA-sponsored meeting of stakeholders in Washington, D.C., Tuesday, Justin McCarthy, a senior vice president at Pfizer and its chief counsel for R&D, said release of potential commercially confidential information could force firms “to make a choice between filing in Europe and potentially losing the ability to get exclusivity in other parts of the world, or filing in those other countries first to preserve exclusivity.”
Drug Industry Daily