Category Archives: compliance

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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Mapping Opportunities with the Non-Physician Prescriber

They write 92% of their prescriptions without consulting a physician and are often the first provider a patient sees, and yet nurse practitioners, physician’s assistants and other non-physician prescribers (NPPs) are still somehow overlooked by pharma as an opportunity to drive sales. A GSW Worldwide report titled The non-physician prescriber will see you now points […]
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The First, and Last, Word on Medication Adherence: Keep Trying!

Patient adherence to medicine is the eternal puzzle for big Pharma:  what combinations of financial incentives, personalized interventions, and just good information work best to push down that stubborn 50 per cent abandonment threshold after six months of treatment?   Certainly there are plenty of new programs on the market, so Pharm Exec believes it’s time […]
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Congress, FDA Should Consider Tech Solutions for Safer Compounding

By Niels Erik Hansen Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in […]
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