FDA Staff Return to Work, but Threat of Second Shutdown Looms
January 29, 2019
By Neozene

FDA staff returned to paid work yesterday after the longest government shutdown in U.S. history. But with temporary funding set to lapse Feb. 15 and President Donald Trump skeptical a deal can be reached, the agency may be plunged back into a shutdown in less than three weeks. In signing a temporary funding bill late last week, Trump has enabled furloughed FDA staff to return to work today. FDA Commissioner Scott Gottlieb said he is working to get back pay to staff by the end of the month and is otherwise taking actions

Analysts: Things could get hairy at FDA if shutdown continues
January 23, 2019
By Neozene

The FDA is still holding it together during the longest government shutdown in history but could face big problems if it continues for another month and user fees dry up. That’s according to two FDA experts cited by analysts at Jefferies, who suggest that in a few weeks reviews could come to a halt, affecting dozens of drug applications and potentially creating a “growing backlog” of delayed programs. Notable near-term marketing applications that could be impacted if the government impasse isn’t resolved include Sage’s postpartum depression therapy brexanolone, Karyopharm’s selinexor for

Medical marketing spend is inching toward $30B, and DTC’s share is growing
January 15, 2019
By Neozene

It’s no surprise that medical marketing spending has skyrocketed in the past 20 years. And while marketing to physicians continues to consume the lion’s share of the almost $30 billion spent overall, direct-to-consumer marketing is catching up. Medical marketers spent $29.9 billion to get their messages in front of healthcare providers and consumers in 2016, up from $17.7 billion in 1997, according to a new survey assessing 20 years of industry marketing spending, published this week in the Journal of the American Medical Association. Of the 2016 total, $20.3 billion was spent