Posted by Michael Wonder on 31 May 2018
Statement from FDA Commissioner on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
31 May 2018 - Our system for developing new drugs is based on a careful equilibrium enshrined in legislation by Congress that seeks to balance access with innovation.
That system enables market-based rewards for novel innovation as a way to create incentives for the time, risk and capital required to develop new medical advances. At the same time, the law allows for brisk competition from safe and effective generic medicines once the period of patent protection or exclusivity has lapsed on a new medicine.
But we know that there are situations where that expected competition isn’t materialising in a timely manner. Sometimes this is the result of tactics that brand drug makers adopt.
