Tag Archives: OIG

Packaging: Regulators Call for Better Patient Information

By Guest Blogger | Published: February 25, 2013
By Jacob Presson, Research Analyst at Cutting Edge Information. Regulations concerning the contents of patient package inserts (known in the EU as “patient information leaflets” or PILs) have in the past erred on the side of caution, making sure that all of the necessary information about side effects and cross-prescription conflicts was included. Pharmaceutical companies have [...]
Posted in Europe, Global, Guest Blog, Regulatory, Strategy, healthcare, patient education | Also tagged , , , , | Leave a comment

Compliance and Legal Not Always Eye-to-Eye

By Ben Comer | Published: December 19, 2012
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 [...]
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Forest Labs Hit with Bad Ad Tattle

By Ben Comer | Published: August 7, 2012
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 on [...]
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Comply or Die: Introducing GSK's New Corporate Integrity Agreement

By Ben Comer | Published: July 6, 2012
Big pharma talks a lot about the changing business model and placing a new emphasis on patients, but the fact remains that quantity of medicines sold, not quality of care provided, is how to get paid (and how to keep investors happy). Despite its egalitarian trappings, the healthcare “ecosystem” is still dominated by the [...]
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Government Crackdown on the C-Suite

By Walter Armstrong | Published: June 2, 2010
Over the past decade, the drug industry has paid tens of billions of dollars to settle state and federal lawsuits involving the False Claims Act—defrauding Medicare and Medicaid, promoting drugs for unapproved uses, paying kickbacks to doctors and pharmacies, and the like. Stories about off-label promotion of drugs with serious adverse effects and no proven [...]
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