Category Archives: Regulatory

Stop Making Sense: Aggregate Spend Reporting

Guest Author: Jeff Gaus, Prolifiq

Disclosure: Prolifiq is a sponsor of

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

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

Regulatory and Marketing Symbiosis from Concept to Commercialization (SLIDES)


Recently two Good Promotional Practices’ bloggers, Elsa and I, gave a live webinar for the Regulatory Affairs Professionals’ Society (RAPS), Regulatory and Marketing Symbiosis from Concept to Commercialization: A Good Promotional Practice. It was a fascinating topic to be invited to speak on and fun to create and present. There was much interaction during the webinar, so we would love to hear your input and questions as well. Here are the slides: 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

Regulatory and Marketing Symbiosis from Concept to Launch: How-To RAPS Webinar

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Date: 30 June 2011
Time: 12:00–1:30pm EDT

Regulatory and marketing are the two internal departments at the center of the development and approval of product claims at medical device and diagnostics companies. Product claims are the lifeblood of promotion during commercial launch and beyond. Regulatory presents the point of view of the US Food and Drug Administration (FDA) and other governmental bodies as to the rules and regulations surrounding promotion, education and scientific exchange. Marketing is the voice of the customer—physicians, healthcare providers, patients, payers—as well as sales. In short, regulatory must ensure that the company and patients are safe while marketing must advocate for healthcare providers, sales and revenue generation. This has historically put these important departments at cross-purposes. Continue reading