Life Science Compliance Update – July Issue

This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D. At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to mid-sized companies that generate $3 billion or less in annual revenue. At the same time, the compliance burdens for all…

Saving Independence -“Compliance” vs “Integrity” Officer

It happens every few years.  The top compliance job gets a new title.  Just in the past 25 years in life sciences, I have seen four major changes.  First, there was Compliance Coordinator (my original title).  Then that was changed to Compliance Officer.  Later the “Chief” was added.  A few years ago, we became Compliance and Risk Officers  Now as Maurice Gilbert’s recent article indicates, the latest version is “Integrity…

A Cloudy Future for the Sunshine Act

The due date for posting another year’s worth of Physician Payment  Sunshine Act (a.k.a. Open Payments) data is fast approaching.  But the future for the Sunshine Act is cloudy.  A new Republican President combined with a recent academic study cast doubt on the Act’s future. Sunshine & the Affordable Care Act The Sunshine Act is part of the Affordable Care Act (“ACA”). Repealing the ACA is the top priority for…

Is Drug Price Transparency DOA?

Once again drug price transparency is in the news. Now it appears that efforts to improve pricing visibility are dead on arrival.  If we look at recent actions by Pfizer and Mylan, it may well be.  At the very least, their actions cast doubt Brent Saunders’ notion of a “social contract” between drug companies and patients. [1] Pfizer Sues Texas Pfizer and the Texas Health and Human Services Commission are in court.  Medicaid…