CBI’s 16th annual Pharmaceutical Compliance Congress was April 16th – April 18th. I was honored to be the keynote speaker on the last day of the conference but attended many of the sessions. As an ethics expert, I live and breathe ethics in Corporate America, so I am always looking at the current trends. I’ve known that the pharma industry has unique challenges, but never realized the depth of compliance and ethics risk until this month. The pharma industry continues to get hit on all sides from the alphabet soup of government agencies including the DOJ, SEC, FDA, HHS, FTC and all 50 state AG’s, not to mention regulators in other countries where they operate.
Take-Away #1 – Recent Pharma settlements are probably an indication of risks that are not going away anytime soon.
According to Potomac River Partners “Year-in-Review” presentation that kicked off the conference, recent US federal civil and criminal settlements include False Claim Act (FCA) violations for DJO Global ($7.6M), Alere ($33.2M), Rotech ($10M), Pfizer ($23.9M), Jazz ($57M pending resolution), Lundbeck ($52.6M pending resolution), Angiodynamics ($12.5M), Actelion ($360M) and AmerisourceBergen ($625M). Insys settled kickback allegations for $150M. Clovis Oncology paid $20M to settle SEC allegations. Olympus Medical paid $85M to settle Federal Drug and Cosmetic Act (FDCA) violations. An FCPA settlement cost Sanofi $25M. EV3 and Covidien paid a combined $30.9 million for FDCA and FCA violations.
Some states have already passed, or are considering, bills for drug price transparency, allowance of off-label promotion, and banning manufacturer co-pay assistance for opioids.
California passed a data privacy law, so look for other states to follow suit. Other nations are already following the EU’s GDPR guidelines on data privacy. This area will be ripe for future enforcement.
Product liability suits have hit AbbVie’s AndroGel and J&J’s talc powder. Anti-opioid actions enjoy bipartisan support at the federal and state level. Expect more litigation and legislative action to crank up this year and next for these issues.
All these actions indicate the pharma industry has on-going problems with off-label selling, kickbacks related to medical provider dinners, speaking fees and grants, market access and technical violations of various federal laws. The personnel posing the greatest risks are domestic and foreign salespeople and third-parties hired outside the U.S.
Part II will follow tomorrow.