Washington. Healthcare. Translated.

Archive for February 2019

Opioids: PS on drugmaker liability

I recently posted some thoughts on the dilemma drugmakers face in balancing their reporting obligations to FDA against their general business model of selling their product. I received feedback that reporting obligations are the least of the drugmakers’ woes.   I’ll stand my ground that drugmakers face a huge task in both policing the drug…

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Opioid Crisis and drugmaker reporting

It’s clear the opioid crisis is real. It’s not as clear, though, what kind of obligation this crisis might trigger for anyone to report their own failings to government enforcers. Let’s take a look.   WE’RE DYING, WHO’S REPORTING? Let’s recall that the catch-phrase “opioid crisis” isn’t a single crisis, but a collection of different…

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