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Bad Alchemy: Turning Estimates Into Fraud

Client Alert | less than 1 min read | 02.08.06

Building on comments at the Nash & Cibinic Roundtable, David Bodenheimer challenges the oxymoronic trend of government agencies and qui tam whistleblowers to assert defective pricing or false claims based upon second-guessing poor estimates. In his article "'False' or 'Inaccurate' Estimates" published in the December 2005 Briefing Paper (http://www.crowell.com/pdf/Expertise/GovtContracts/BriefingPapers_Bodenheimer.pdf), he explains that estimating -- due to its inherently risky and predictive nature -- requires judgmental forecasts long recognized as appropriate by government pricing guidelines and not suitable for defective pricing and fraud suits complaining about bad estimates of future events.

Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....