A Generic Manufacturer’s Current Pressures and Opportunities Consolidation of purchase power in the past 20 years has dramatically changed the landscape for generic manufacturers; and recent events are making it worse: active prosecution for price-fixing, the FDA...
New York Opioid Tax & Minnesota Regulatory Fee Changes As the changes to state laws per DSCSA continues to sweep the country, the Opioid Epidemic has now also begun to significantly impact the state regulation of the pharmaceutical supply chain. Specifically,...
10 Key Takeaways from the 2019 Controlled Substances Summit ACI Controlled Substances Summit 1. Suspicious Order Monitoring (“SOM”) Systems: DEA cannot and will not endorse a SOM System. Just because the DEA has not made notifications on your legacy SOM...
Could OptumRx’s 2016 Requirement Be a Quid Pro Quo Arrangement? The ongoing legal case has shed new light on the motivations behind, and the execution of, OptumRx’s 2016 requirement. Due Diligence Our observations from the court hearing shows lack of due diligence:...
What the OptumRx Litigation Means to Industry We have received a lot of questions over the past few weeks on how the lawsuit is progressing and what it will mean for the industry. Although we do not have any definitive answers yet (a court decision could come as early...
