Using Drug Safety to Push Generics
This article was originally published in RPM Report
The brandname pharmaceutical industry faces a long list of challenges, but two items top the list: concerns about drug safety following the withdrawal of Merck & Co. Inc.'s rofecoxib (Vioxx) and the wave of blockbuster patent expirations coming in the next several years. If Express Scripts Inc. is right, those two challenges can be combined to make life even tougher for Big Pharma.
You may also be interested in...
US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.
Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.
FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?