Category 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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Compliance and Reporting: The Case for a Single System

by James Pierce Pharmaceutical companies are awash in a sea of compliance regulations that affect their business operations both inside and outside the US. This August, one more compliance wave will crest when the Physician Payments Sunshine Act (PPSA) begins requiring pharmaceutical companies to track and report virtually all payments to health care providers (HCPs). […]
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Breaching the Great Wall: Major Pharma Changes Proposed in China

With a revision of China’s basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation. Dr. Wang Chenguang, Dean of Tsinghua Law School Behind the vaulting growth statistics that make China the centerfold in Big Pharma’s global playbook is a […]
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Lanham Act: Peer-Review on Trial

Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage? The dividing line between fact and fiction becomes increasingly blurry in the age of prolific […]
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Better Safe than Sorry: Assessing Suicide Risk in Clinical Trials

With the FDA striving to avoid post-market reactions to drugs with worrisome side-effect profiles, preventive measures that screen for obvious risks such as suicidal behavior and abuse potential are making their way into the lexicon of regulators and drug developers alike, in tandem with its mandate that stresses safety first and efficacy a close second. […]
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