Senators Ask GAO to Investigate Potential Orphan Drug Act Abuse
In a March 3, 2017, letter to the United States Government Accountability Office, Senators Orrin Hatch, Chuck Grassley, and Tom…
Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
OPDP Picks Up Steam on Enforcement Letters
After a fairly slow 2016, the United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP)…
JAMA Harps on PAOs
JAMA Internal Medicine recently published an article, “Patient Advocacy Organizations, Industry Funding, and Conflicts of…
DOJ Has Third Highest Annual Recovery in FCA History
The United States Department of Justice has announced the fiscal year 2016 recoveries from civil False Claims Act. This…
ACCME President and CEO Calls for Healthcare Leaders to Leverage CME
Graham McMahon, MD, MMSc, President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), recently…
Fourth Promotional Review Committee Compliance and Best Practices – Midwest
On May 16th and 17th, 2017, ExL Events will host the Fourth Promotional Review Committee Compliance and Best Practices Conference…
CDER 2017 Guidance Agenda
In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and…
Access Problems Persist with Open Payments…
With less than two days left to submit and attest to data for the June 30, 2017, publication, manufacturers and group purchasing…
Bristol-Myers Squibb Settles Off-Label Promotion Case for $19.5 Million
Late last year, Bristol-Myers Squibb (BMS) settled with the government to resolve allegations that spanned several states that it…
Medical Devices & False Claims – Shire’s Settlement Is One for the…
We have seen many large False Claims and Anti Kickback settlements with pharmaceutical companies and the prescriptions…