Tag Archives: rules

Live Monitoring of Speaker Programs: Expert How-Tos


It is a tortuous path for pharmaceutical, medical device and diagnostics companies to produce industry-sponsored speaker programs that are up to ethical and legal guidelines. In recent CIAs, training and promotional review of slide presentations are no longer enough. Live monitoring is required.

Dan Koerner does a great job summarizing which companies are required Continue reading

Stop Making Sense: Aggregate Spend Reporting

Guest Author: Jeff Gaus, Prolifiq

Disclosure: Prolifiq is a sponsor of goodpromotionalpractices.com

I spent two days in Chicago at the Q1 Productions Pharmaceutical & Medical Device Sales & Marketing Compliance seminar; approximately 80 senior executives of the who’s who in life sciences regulatory compliance participated.

My biggest take away from the professional industry presentations has to do with Aggregate Spend Reporting. This Federal legislation, while well-intentioned and clearly designed to remove “commercial incentives” from influencing clinical decisions made by physicians and healthcare organizations, has created mind-boggling requirements on the entire life sciences industry.

The relationship between life sciences companies and healthcare providers is complex. Healthcare providers can simultaneously be development collaborators, agents, and customers. Continue reading

Medical Devices: The New Low-Hanging Fruit for Healthcare Fraud?


A highlight from the 7th Annual Medical Device and Diagnostic Compliance Congress in June was the talk by Jeremy Sternberg, deputy chief of the healthcare fraud unit, U.S. Attorney’s Office for the District of Massachusetts. His succinct and compelling story to medical device manufacturers, sales agents and distributors can be summarized as: We are smarter than ever (thanks pharma!), and we are coming after the new low-hanging fruit: medical devicesContinue reading

From Policy to Behavioral Change: 4 How-Tos from ex-AIG CCO


“Policies are not enough,” said Suzanne Rich Folsom, former Chief Compliance Officer for AIG, speaking at the recent Dow Jones Global Compliance Symposium .

Policies are only the very first step in an organizational culture that is truly compliant with regulatory requirements. If you want to protect your company, here are four insightful how-tos from Suzanne Rich Folsom and other @dj_gcs speakers to move your policies from paper documents to meaningful behavioral change: Continue reading

FDA Ready to Rumble: 3 To Dos for CEOs


For CEOs of companies regulated by the Food and Drug Administration (FDA), the message is clear: If you aren’t working to seek out and prevent off-label marketing within your company, you could be charged with a crime.

Rick Blumberg, Deputy Chief Counsel for Litigation at FDA, recently  spoke at the 7th Annual Medical Device and Diagnostic Compliance Congress. He said the FDA is looking for opportunities to prosecute individuals — and he gave CEOs as examples – using the Park strict liability doctrine. Continue reading