Tag Archives: compliance

The Curious Case Of AstraZeneca v. ACE

by Mike Kelly and Andrew Dupre Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned. From 2003 to 2012, AstraZeneca Plc was locked in one of the largest mass tort litigations in the United States, defending its blockbuster second generation atypical antipsychotic product Seroquel from allegations of failure-to-warn of […]
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Changing the DNA of Pharma Patient Adherence Programs

by Grant Corbett Epigenetics is the study of changes in human gene expression, in particular from environmental factors.  Pharma is also experiencing epigenetic change.  Human genes are formed from DNA, which are instructions much like a blueprint.  Similarly, the environment is changing pharmaceutical DNA and how brand marketing is instructed.
Posted in compliance, E-Media, healthcare, Marketing, Patient Communication, patient compliance, patient education | Also tagged , , , , , | 3 Comments

Five Compliance Questions to Ask Yourself, from the DOJ

At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations. Frimpong said non-compliance boils down to a failure of individuals, and offered five questions for chief compliance officers to ask themselves […]
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Compliance and Legal Not Always Eye-to-Eye

As the role and stature of the compliance officer grows, legacy senior management structures and hierarchies can accidentally pit lawyers against one another. What is strictly legal in the context of sales and marketing practices, working with government officials in global markets, and running and reporting on clinical programs, may not always be the last […]
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Forest Labs Hit with Bad Ad Tattle

Forest Labs has had a tough time with regulators over the last two years. The company’s sales reps can’t seem to stop breaking the law. The latest offense, which generated an Untitled Letter from the Office of Prescription Drug Promotion (OPDP), was brought to light through OPDP’s Bad Ad program, which encourages physicians to report […]
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