The goal of the PV Legislation is increased access to information and greater transparency of processes, in the wake of the French company Servier’s Mediator scandal. Licensed as an add-on for hyperlipidaemia and diabetes, but used off-label for obesity, Mediator reportedly caused 500 to 2000 deaths in its 33 years on the market. The new legislation aims to prevent similar drug safety issues from lying undetected for so long.
“The implications of the PV Legislation are extensive, with implications for both US and European drug manufacturers,”
“Any company that has a European presence will need to integrate its processes and activities on the collection, monitoring and evaluation of information on the adverse effects of medications. The new legislation will replace Volume 9A of the rules governing medicinal products; that is how extensive the changes will be. Companies have spent the last 9 to 12 months preparing for it, but a full integration will require a lot more time.”
US companies also need to be aware of the recent Investigational New Drug (IND) Final Rule, and the upcoming New Drug Application (NDA) Final Rule and manufacturing supply chain regulations. “Companies must take this very seriously and figure out a way to get adequate control of their supply chains,” Beninger adds.
The Prescription Drug User Fee Act (PDUFA) is also up for changes by September 2012. Beninger noted: “We have a good idea of what it covers on the statutory level, but not at the regulatory level.”
“There has been a paradigm shift from ‘safe and effective’ to ‘benefit-risk’
“Companies should consider how audit ready they are. That has implications for many of their activities. Being audit ready is one of the most important responsibilities that the PV department has. It must be ready to answer any question that an auditor may have. This is more than just compliance, but about all of their processes. Companies need to ask themselves one question: Are they audit ready?” Beninger concludes.
The marcus evans 2nd Global Pharmacovigilance & Adverse Event Reporting Conference will take place at Le Meridien Cambridge, Cambridge, MA, May 22-24, 2012.