Analysis Group Health Care Experts Publish Articles in Law360 on Payments to Physicians, Opioid Use, and Biosimilar Entry
May 3, 2016
Experts from Analysis Group's Health Care practice have recently published several Law360 articles on pressing issues in the health care sector, including payments to physicians, opioid use, and biosimilar entry.
In “Correlation Or Cause: Brand-Name Drug Prescription Rates,” Managing Principal Paul Greenberg, Vice President Tamar Sisitsky, and Vice President Richard Mortimer take issue with a recent ProPublica report in which a causal connection is implied between payments to physicians and subsequent prescribing. They caution that correlation is not evidence of causation, and that aggregate data are insufficient to establish such relationships in the context of kickback allegations. (March 23)
“Viewing Recent Opioid Regulations In Context,” by Vice President Crystal Pike, Manager Kenneth Weinstein, Manager Pavel Darling, and Paul Greenberg, examines possible consequences for chronic pain patients of recent efforts by the CDC and FDA to curb opioid misuse. They draw on Analysis Group's long-standing empirical assessments in this context to explore existing patterns of use and identify areas where further research would be instructive. (April 1)
In “Can The Life Sciences Industry Bank On Biosimilars?” Richard Mortimer, Tamar Sisitsky, and Paul Greenberg consider the potential economic impact of biosimilars in comparison with small-molecule generics. The recent FDA approval of Inflectra, the second approved biosimilar, has generated substantial interest in this topic as patents on several top-selling biologics are set to expire or are challenged by biosimilar applicants. Further attention is focused on the FDA as it continues to fine-tune its approach to biosimilar approvals. (April 13)
Analysis Group has amassed considerable experience in each of these three areas and has applied this expertise to such issues as government investigations triggered by alleged False Claims Act and Anti-Kickback Statute violations, Drug Enforcement Administration actions, patent challenges and related antitrust litigations, and corporate strategy issues concerning optimal responses to regulatory challenges or optimal pricing practices.